Px Posterior Lumbar Interbody Fusion System
Px PEEK INTERBODY FUSION SYSTEM INDICATIONS FOR USE The Innovasis Px PEEK IBF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2- S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via either a posterior (PLIF) or modified transforaminal (T-PLIF) approach. This device is intended to be used in pairs and with internal supplemental spinal fixation systems such as the Innovasis Excella Spinal System. The interior of the Px implant is intended to be packed with autograft. For additional product information including warnings, precautions and adverse effects concerning spinal fixation implants refer to the product insert. CONTRAINDICATIONS (EXCLUSION CRITERIA): Use of this system is contraindicated when there is active systemic infection, infection localized to the site of the proposed implantation, or when the patient has demonstrated allergy or foreign body sensitivity to any of the implant materials. Severe osteoporosis may prevent adequate fixation and thus preclude the use of this or any other orthopaedic implant. Conditions that may place excessive stress on the bone and implant, such as severe obesity or degenerative diseases are relative contraindications. The decision whether to use these devices under these conditions must be made by the physician taking into account the risks versus the benefits to the patient. Use of these implants is relatively contraindicated in patients whose activity, mental capacity, mental illness, alcoholism, drug abuse, occupation, or lifestyle may interfere with their ability to follow postoperative restrictions and who may place undue stresses on the implant during bone healing and may be at a higher risk of implant failure. INNOVASIS Px Guide / PG 1
Px PEEK INTERBODY FUSION SYSTEM WARNING: Correct selection of the implant is EXTREMELY Important. The potential for satisfactory anterior column support is increased by the selection of the proper size device. While proper selection can help minimize risks, the size and shape of human bones present limitations on the size, shape and strength of implants. Internal fixation devices cannot withstand activity levels equal to those placed on normal healthy bone. No implant can be expected to withstand indefinitely the unsupported stress of full weight bearing. Implants can break when subjected to the increased loading associated with delayed union. Internal fixation appliances are load sharing devices which are used to obtain an alignment until normal healing occurs. If healing is delayed, or does not occur, the implant may eventually break due to material fatigue. The degree of success of union, loads produced by weight bearing, and activity levels will among other conditions, dictate the longevity of the implant. Notches, scratches or bending of the implant during the course of surgery may also contribute to early failure. Patients should be fully informed of the risks of implant failure. INNOVASIS Px Guide / PG 2
Px PEEK INTERBODY FUSION SYSTEM PRODUCT OVERVIEW The Px system is for Posterior Lumbar Interbody Fusion (PLIF). The implants are made from either standard PEEK per ASTM F2026 or Invibio PEEK-OPTIMA HA Enhanced. The HA Enhanced version is integrated with an osteoconductive hydroxyapatite (HA). The implant is radiolucent allowing straightforward assessment of the fusion process, while three tantalum spheres enable implant visualization during the surgical procedure. The device is available in multiple size options to facilitate a more precise anatomical fit. It has a tapered leading edge which aids in implant insertion due to limited anatomical space, and features a slightly convex profile to match the anatomy and anti-migration teeth to ensure implant stability during the fusion process. The large graft cavity provides increased volume for autograft loading. The Px system features a unique inserter design which helps prevent cross threading and minimizes implant breakage. MARKER LOCATIONS Lordosis Height 2 mm 2 mm INNOVASIS Px Guide / PG 3
INSTRUMENTS OVERVIEW INSTRUMENTS LS-181 8mm Inserter LS-240 10mm Inserter LS-258 Implant Pusher LS-211 Implant Pusher LS-209 Disc Shaver, Sizes 8mm - 16mm LS-210 Paddle Distractor, Sizes 7mm - 16mm INNOVASIS Px Guide / PG 4
INSTRUMENTS OVERVIEW INSTRUMENTS (CONT.) LS-223 T-Handle LS-216 Bone Graft Tamp LS-215 Graft Block INNOVASIS Px Guide / PG 5
INSTRUMENTS OVERVIEW INSTRUMENTS (CONT.) LS-242-8 8mm Box Chisel LS-263 Slide Hammer LS-226 9mm Straight Rasp LS-227 5mm Slotted Teeth Curette LS-228 5mm Down Curette INNOVASIS Px Guide / PG 6
INSTRUMENTS OVERVIEW INSTRUMENTS (CONT.) LS-229 5mm Up Curette LS-230 10mm Left Angled Curette LS-231 10mm Right Angled Curette LS-232 5mm Bayonet Straight Curette LS-233 5mm Bayonet Down Curette LS-234 5mm Bayonet Up Curette INNOVASIS Px Guide / PG 7
INSTRUMENTS OVERVIEW INSTRUMENTS (CONT.) LS-235 8mm Teardrop Straight Curette LS-236 8mm Teardrop Down Curette LS-237 8mm Teardrop Angled Curette LS-238 9.5mm Straight Osteotome LS-239 9.5mm Curved Osteotome INNOVASIS Px Guide / PG 8
INSTRUMENTS OVERVIEW INSTRUMENTS (OPTIONAL) LS-241 12mm Inserter LS-261 8mm Wide Implant Trial, Sizes 8mm - 16mm LS-264 10mm Wide Implant Trial, Sizes 8mm - 16mm LS-265 12mm Wide Implant Trial, Sizes 8mm - 16mm CLEANING: The Px inserter must be disassembled prior to cleaning. To disassemble, simply pull on the knob to separate the inner shaft from the inserter body. INNOVASIS Px Guide / PG 9
APPROACH Upon proper targeting of the affected level(s) a skin incision is made. The soft tissues are retracted to provide the desired visualization of the bony anatomy. The lateral inferior portion of the inferior facet of the superior vertebrae is removed with an osteotome, bur or kerrison. For a bilateral PLIF approach repeat the process on the contralateral side. A conventional discectomy is then performed by incising the annulus with a scalpel blade lateral to the dural sac. Soft fragments are then removed from the intradiscal space with rongeurs. If there is significant disc space collapse, a complete discectomy may not be possible until disc space distraction is accomplished. SITE PREPARATION Remove disc material using the disc shavers. Attach the appropriate size disc shaver to the large Hudson T-Handle and insert the shaver until the cutting edge is completely within the disc space. Rotate the disc shaver to remove disc and endplate cartilage. The disc shavers feature cutting flutes that allow the instrument to cut in two directions by rotating the T-Handle clockwise and counterclockwise as needed to scrape end-plate material and promote bleeding. INNOVASIS Px Guide / PG 10
DISTRACTION Distraction of the disc space can be achieved using either the paddle distractors or disc shavers. To use the paddle distractors for distraction, attach the smallest paddle distractor to the large Hudson T-Handle and insert it into the disc space horizontally and rotate 90, using larger sizes until the desired distraction is achieved. To use the disc shavers for distraction, attach the smallest disc shaver to the large Hudson T-handle and insert it into the disc space horizontally and rotate 90, using larger sizes until the desired distraction is achieved. Note: use caution while using the paddle distractors or disc shavers for distraction to avoid damage to the endplates. INNOVASIS Px Guide / PG 11
ENDPLATE PREPARATION Once the disc space is distracted, final discectomy and endplate preparation can be performed by thoroughly decorticating the endplate above and below the disc space using rasps or curettes. With osteotomes, remove osteophytes and the posterior lip of adjacent vertebral bodies. With the dura safely retracted, a box chisel is attached to the T-handle and used to prepare a rectangular channel for the Interbody Spacer. The box chisel should be oriented so that the cutting edges are parallel with the endplates and then gently tapped into the disc space with a mallet to the desired depth. The box chisel can be removed from the disc space with the use of the slide hammer. INNOVASIS Px Guide / PG 12
INSTRUMENT REMOVAL SLIDE HAMMER OPTIONS The slide hammer offers two options for attaching to instruments in the system. OPTION 1 The Slide Hammer is designed to remove the inserter. One end of the Slide Hammer attaches to the inserter as shown. OPTION 2 The opposite end of the Slide Hammer is designed to remove instruments with a large hudson connection such as the Distractors, Shavers and Box Chisels. The Slide Hammer attaches as shown. Note: When attaching the Slide Hammer to instruments with a large hudson connection the button must be pressed while connecting it. The button must also be pressed when disconnecting the instrument. INNOVASIS Px Guide / PG 13
SIZING THE DISC SPACE The disc space height is sized using a series of trials or paddle distractors. The trials and paddle distractors are serially increased until the appropriate fit within the disc space is acheived. The trials and paddle distractors should fit snugly within the disc space; however, care should be taken not to oversize the implant, as this may result in difficult insertion of the implant and possible subsidence. Note: The Px trials and paddle distractors match the overall height of the corresponding implant. INNOVASIS Px Guide / PG 14
IMPLANT PREPARATION The Px Interbody Spacer is mounted on the inserter by fitting the spacer over the two stabilizing fingers and then turning the knurled thumbwheel clockwise until a snug fit is acheived. INNOVASIS Px Guide / PG 15
IMPLANT PREPARATION After the Interbody Spacer has been selected and attached to the inserter, it is filled with bone graft by means of the graft block and graft tamp. Bone graft material is loaded into the cavity of the Px Interbody Spacer by placing it into the corresponding graft block cavity and impacting graft material into the Interbody Spacer with the bone graft tamp. INNOVASIS Px Guide / PG 16
IMPLANT INSERTION When the Interbody Spacer has been inserted, it can be detached from the inserter by rotating the knurled thumbwheel counterclockwise. If necessary, the position of the Interbody Spacer can be improved with the implant pusher. Fluoroscopy may be useful in determining the appropriate trajectory for insertion and appropriate final positioning. The presence of tantalum markers enables the spacer position to be precisely determined in the sagittal, coronal and axial planes. Before the second spacer is placed, the anterior and medial sides of the intervertebral space are filled with autogenous cancellous bone or with a bone substitute material. Note: should it become necessary to remove the Interbody Spacer, it may be retrieved from the disc space by re-attaching it to the inserter. This can be accomplished by threading the inserter fully into the Interbody Spacer. Once the Interbody Spacer is attached to the inserter, the Px slide hammer can be attached to the proximal end of the inserter, then with controlled impact, the implant can be carefully removed from the disc space. Caution: an explanted Interbody Spacer must never be re-used or re-implanted. Even though the device may appear to be undamaged, it may have defects which can lead to failure of the device. Sagittal view INNOVASIS Px Guide / PG 17
IMPLANTS Catalog # Description Catalog # Description X20808255 8W x 8H x 25L x 5 X20808250 8W x 8H x 25L x 0 X20809255 8W x 9H x 25L x 5 X20809250 8W x 9H x 25L x 0 X20810255 8W x 10H x 25L x5 X20810250 8W x 10H x 25L x 0 X20811255 8W x 11H x 25L x 5 X20811250 8W x 11H x 25L x 0 X20812255 8W x 12H x 25L x 5 X20812250 8W x 12H x 25L x 0 X20813255 8W x 13H x 25L x 5 X20813250 8W x 13H x 25L x 0 X20814255 8W x 14H x 25L x 5 X20814250 8W x 14H x 25L x 0 X20815255 8W x 15H x 25L x 5 X20815250 8W x 15H x 25L x 0 X20816255 8W x 16H x 25L x 5 X20816250 8W x 16H x 25L x 0 X21008255 10W x 8H x 25L x 5 X21008250 10W x 8H x 25L x 0 X21009255 10W x 9H x 25L x 5 X21009250 10W x 9H x 25L x 0 X21010255 10W x 10H x 25L x 5 X21010250 10W x 10H x 25L x 0 X21011255 10W x 11H x 25L x 5 X21011250 10W x 11H x 25L x 0 X21012255 10W x 12H x 25L x 5 X21012250 10W x 12H x 25L x 0 X21013255 10W x 13H x 25L x 5 X21013250 10W x 13H x 25L x 0 X21014255 10W x 14H x 25L x 5 X21014250 10W x 14H x 25L x 0 X21015255 10W x 15H x 25L x 5 X21015250 10W x 15H x 25L x 0 X21016255 10W x 16H x 25L x 5 X21016250 10W x 16H x 25L x 0 X21008280 10W x 8H x 28L x 0 X21008320 10W x 8H x 32L x 0 X21009280 10W x 9H x 28L x 0 X21009320 10W x 9H x 32L x 0 X21010280 10W x 10H x 28L x 0 X21010320 10W x 10H x 32L x 0 X21011280 10W x 11H x 28L x 0 X21011320 10W x 11H x 32L x 0 X21012280 10W x 12H x 28L x 0 X21012320 10W x 12H x 32L x 0 X21013280 10W x 13H x 28L x 0 X21013320 10W x 13H x 32L x 0 X21014280 10W x 14H x 28L x 0 X21014320 10W x 14H x 32L x 0 X21015280 10W x 15H x 28L x 0 X21015320 10W x 15H x 32L x 0 Note: All sizes listed are also available in HA PEEK material. The catalog numbers and descriptions are the same for the HA PEEK with exception of the prefix in the catalog numbers - the HA PEEK sizes have an HA prefix instead of X2. INNOVASIS Px Guide / PG 18
IMPLANTS (OPTIONAL SIZES) Catalog # Description Catalog # Description X20808225 8W x 8H x 22L x 5 X20808220 8W x 8H x 22L x 0 X20809225 8W x 9H x 22L x 5 X20809220 8W x 9H x 22L x 0 X20810225 8W x 10H x 22L x 5 X20810220 8W x 10H x 22L x 0 X20811225 8W x 11H x 22L x 5 X20811220 8W x 11H x 22L x 0 X20812225 8W x 12H x 22L x 5 X20812220 8W x 12H x 22L x 0 X20813225 8W x 13H x 22L x 5 X20813220 8W x 13H x 22L x 0 X20814225 8W x 14H x 22L x 5 X20814220 8W x 14H x 22L x 0 X20815225 8W x 15H x 22L x 5 X20815220 8W x 15H x 22L x 0 X20816225 8W x 16H x 22L x 5 X20816220 8W x 16H x 22L x 0 X21008225 10W x 8H x 22L x 5 X21008220 10W x 8H x 22L x 0 X21009225 10W x 9H x 22L x 5 X21009220 10W x 9H x 22L x 0 X21010225 10W x 10H x 22L x 5 X21010220 10W x 10H x 22L x 0 X21011225 10W x 11H x 22L x 5 X21011220 10W x 11H x 22L x 0 X21012225 10W x 12H x 22L x 5 X21012220 10W x 12H x 22L x 0 X21013225 10W x 13H x 22L x 5 X21013220 10W x 13H x 22L x 0 X21014225 10W x 14H x 22L x 5 X21014220 10W x 14H x 22L x 0 X21015225 10W x 15H x 22L x 5 X21015220 10W x 15H x 22L x 0 X21016225 10W x 16H x 22L x 5 X21016220 10W x 16H x 22L x 0 X21208280 12W x 8H x 28L X 0 X21209300 12W x 9H x 30L x 0 X21209280 12W x 9H x 28L X 0 X21210300 12W x 10H x 30L x 0 X21210280 12W x 10H x 28L X 0 X21211300 12W x 11H x 30L x 0 X21211280 12W x 11H x 28L X 0 X21212300 12W x 12H x 30L x 0 X21212280 12W x 12H x 28L X 0 X21213300 12W x 13H x 30L x 0 X21213280 12W x 13H x 28L X 0 X21214300 12W x 14H x 30L x 0 X21214280 12W x 14H x 28L X 0 X21215300 12W x 15H x 30L x 0 X21215280 12W x 15H x 28L X 0 X21216300 12W x 16H x 30L x 0 X21216280 12W x 16H x 28L X 0 X21209320 12W x 9H x 32L x 0 X21210320 12W x 10H x 32L x 0 X21211320 12W x 11H x 32L x 0 X21212320 12W x 12H x 32L x 0 X21213320 12W x 13H x 32L x 0 X21214320 12W x 14H x 32L x 0 X21215320 12W x 15H x 32L x 0 X21216320 12W x 16H x 32L x 0 INNOVASIS Px Guide / PG 19
INSTRUMENTS Catalog # LS-242-8 LS-210-7 LS-210-8 LS-210-9 LS-210-10 LS-210-11 LS-210-12 LS-210-13 LS-210-14 LS-210-15 LS-210-16 LS-209-8 LS-209-9 LS-209-10 LS-209-11 LS-209-12 LS-209-13 LS-209-14 LS-209-15 LS-209-16 LS-181 LS-240 LS-263 LS-211 LS-258 LS-215 LS-216 LS-223 LS-226 LS-227 LS-228 LS-229 LS-230 LS-231 LS-232 LS-233 LS-234 LS-235 LS-236 LS-237 LS-238 LS-239 Description BOX CHISEL, 8mm PADDLE DISTRACTOR, 7mm PADDLE DISTRACTOR, 8mm PADDLE DISTRACTOR, 9mm PADDLE DISTRACTOR, 10mm PADDLE DISTRACTOR, 11mm PADDLE DISTRACTOR, 12mm PADDLE DISTRACTOR, 13mm PADDLE DISTRACTOR, 14mm PADDLE DISTRACTOR, 15mm PADDLE DISTRACTOR, 16mm DISC SHAVER, 8mm DISC SHAVER, 9mm DISC SHAVER, 10mm DISC SHAVER, 11mm DISC SHAVER, 12mm DISC SHAVER, 13mm DISC SHAVER, 14mm DISC SHAVER, 15mm DISC SHAVER, 16mm INSERTER, 8mm INSERTER, 10mm SLIDE HAMMER IMPLANT PUSHER, STRAIGHT IMPLANT PUSHER, STRAIGHT GRAFT BLOCK BONE GRAFT TAMP HANDLE, STANDARD T, LARGE HUDSON 9mm STRAIGHT RASP 5mm SLOTTED TEETH CURETTE 5mm DOWN CURETTE 5mm UP CURETTE 10mm LEFT ANGLED CURETTE 10mm RIGHT ANGLED CURETTE 5mm BAYONET STRAIGHT CURETTE 5mm BAYONET DOWN CURETTE 5mm BAYONET UP CURETTE 8mm TEARDROP STRAIGHT CURETTE 8mm TEARDROP DOWN CURETTE 8mm TEARDROP ANGLED CURETTE 9.5mm STRAIGHT OSTEOTOME 9.5mm CURVED OSTEOTOME INNOVASIS Px Guide / PG 20
INSTRUMENTS (OPTIONAL) Catalog # LS-261-8 LS-261-9 LS-261-10 LS-261-11 LS-261-12 LS-261-13 LS-261-14 LS-261-15 LS-261-16 LS-264-8 LS-264-9 LS-264-10 LS-264-11 LS-264-12 LS-264-13 LS-264-14 LS-264-15 LS-264-16 LS-265-8 LS-265-9 LS-265-10 LS-265-11 LS-265-12 LS-265-13 LS-265-14 LS-265-15 LS-265-16 LS-241 LS-242-9 LS-242-10 LS-242-11 LS-242-12 LS-242-13 LS-242-14 LS-242-15 LS-242-16 Description IMPLANT TRIAL, 8mm x 8mm IMPLANT TRIAL, 8mm x 9mm IMPLANT TRIAL, 8mm x 10mm IMPLANT TRIAL, 8mm x 11mm IMPLANT TRIAL, 8mm x 12mm IMPLANT TRIAL, 8mm x 13mm IMPLANT TRIAL, 8mm x 14mm IMPLANT TRIAL, 8mm x 15mm IMPLANT TRIAL, 8mm x 16mm IMPLANT TRIAL, 10mm x 8mm IMPLANT TRIAL, 10mm x 9mm IMPLANT TRIAL, 10mm x 10mm IMPLANT TRIAL, 10mm x 11mm IMPLANT TRIAL, 10mm x 12mm IMPLANT TRIAL, 10mm x 13mm IMPLANT TRIAL, 10mm x 14mm IMPLANT TRIAL, 10mm x 15mm IMPLANT TRIAL, 10mm x 16mm IMPLANT TRIAL, 12mm x 8mm IMPLANT TRIAL, 12mm x 9mm IMPLANT TRIAL, 12mm x 10mm IMPLANT TRIAL, 12mm x 11mm IMPLANT TRIAL, 12mm x 12mm IMPLANT TRIAL, 12mm x 13mm IMPLANT TRIAL, 12mm x 14mm IMPLANT TRIAL, 12mm x 15mm IMPLANT TRIAL, 12mm x 16mm INSERTER, 12mm BOX CHISEL, 9mm BOX CHISEL, 10mm BOX CHISEL, 11mm BOX CHISEL, 12mm BOX CHISEL, 13mm BOX CHISEL, 14mm BOX CHISEL, 15mm BOX CHISEL, 16mm INNOVASIS Px Guide / PG 21
M Innovasis, Inc. 614 East 3900 South Salt Lake City, UT 84107 Tel: +1 801.261.2236 Tel: 1 877.261.2236 Fax: +1 801.261.0573 Info@Innovasis.com L00041 REV D : Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands