T-PAL Spacer System. Transforaminal posterior atraumatic lumbar spacer system. One instrument, one technique Accommodates both open and MIS approaches A PEEK implant that works with patient anatomy Streamlined trial sizing process Familiar instrument sets
T-PAL Spacer System. Transforaminal posterior atraumatic lumbar spacer system. The T-PAL Spacer System enhances the benefits of traditional kidney bean style implants and TLIF surgery by employing several ease-of-use features. True trial sizing and placement testing Rigid or pivoting spacer control Synthes 1
T-PAL and MIS Accommodates both open and MIS approaches Traditionally, TLIF surgery with kidney bean shaped implants often required stick trials, an implant inserter, straight impactors, angled impactors, and multiple instrument changes to insert the spacer and move it into final position. The T-PAL Spacer System instead uses the pivoting implant applicator to trial size and to position the implant. The shaft of the applicator, in the rigid position, is streamlined to fit through a tube. The same tool then allows the trial or spacer to pivot into final position. The T-PAL spacer and instruments may be used through 22 mm diameter Insight tubes, found in the Insight Access Tube Set (01.615.101). Surgeons can also use the Insight Access Retractor Set (01.615.100). 2 Synthes T-PAL Spacer System
Pivoting Implant Applicator One instrument, one technique Familiar Process Approach, disc preparation, and final implant location are the same as traditional TLIF procedures Versatility Trial sizing and implant placement use the same tool and technique No need for angle impactors Fewer tool transitions True Sizing Allows true trial sizing and placement testing Control Rigid, streamlined position during insertion Pivoting during positioning Security ring designed to prevent unintentional implant release Synthes 3
Spacers A PEEK implant that works with patient anatomy The next generation of kidney bean spacers includes several new features: Positioning Contoured guide rails steer implant into position Self-distracting, bullet-shaped nose Contoured guide rails Visualization Radiographic markers to verify placement Performance Pyramidal teeth to resist implant migration 5 lordotic angle (except 7 mm height) Axial window for packing with autograft material Test results show that the T-PAL Spacer can withstand clinically relevant loads in the lumbar spine 1 Note: Mechanical test results are not necessarily indicative of clinical performance. 1 T-PAL Spacer can endure compressive loads in excess of 18 kn. Test data on file at Synthes. 4 Synthes T-PAL Spacer System
Trials A streamlined trial sizing process Trial sizing and implant placement use the same tool and technique Trials are not detachable Two applicator tools included in the instrument set to facilitate tool transitions Trials and implants in 11 heights and 2 footprints accommodate patient anatomy Synthes 5
Instrumentation Familiar instrument sets The T-PAL Spacer Instrument and Implant Set is a straightforward set that features bayoneted instruments, silicone grips, matte finish, and the new pivoting implant applicator. Slap hammer Slotted mallet Spacer remover 01.812.001 T-PAL Spacer Instrument and Implant Set Compatible Sets 01.605.500 Minimally Invasive Posterior Instrument Set (MIPI) 01.803.100 OPAL System 105.151 T-PLIF Minimally Invasive Instrument Set 105.152 T-PLIF Auxiliary Instrument Set Bayoneted scalpel handle Bayoneted impactor (Knob) (Inner shaft) (Handle) Pivoting implant applicator (x 2) Spacers Trial spacers 12 mm x 32 mm, 7 mm 17 mm height Trial spacers 10 mm x 28 mm, 7 mm 17 mm height 6 Synthes T-PAL Spacer System
T-PAL Instrument and Implant Set (01.812.001) Graphic Case 60.812.001 Graphic Case, for T-PAL Instruments and Implants Instruments 03.605.500 Impactor, standard, bayoneted 03.809.972 Oracle Slap Hammer 03.809.973 Bayoneted Scalpel Handle 03.812.001 T-PAL Spacer Applicator Handle, 2 ea. 03.812.003 T-PAL Spacer Applicator Inner Shaft, 2 ea. 03.812.004 T-PAL Spacer Applicator Knob, 2 ea. 03.812.005 T-PAL Spacer Remover 03.812.307 T-PAL Trial Spacers, 10 mm x 28 mm, 03.812.317 7 mm 17 mm heights 03.812.507 T-PAL Trial Spacers, 12 mm x 32 mm, 03.812.517 7 mm 17 mm heights PDL102 Slotted Mallet T-PAL Spacers, 10 mm x 28 mm, 2 ea. Height Posterior Autograft (mm) Height (mm) Volume (cc)* 08.812.007 7 7.0 0.39 08.812.008 8 7.2 0.42 08.812.009 9 8.2 0.50 08.812.010 10 9.2 0.58 08.812.011 11 10.2 0.66 08.812.012 12 11.2 0.77 08.812.013 13 12.2 0.88 08.812.014 14 13.2 0.99 08.812.015 15 14.2 1.09 08.812.016 16 15.2 1.20 08.812.017 17 16.2 1.31 T-PAL Spacers, 12 mm x 32 mm, 2 ea. Height Posterior Autograft (mm) Height (mm) Volume (cc)* 08.812.207 7 7.0 0.63 08.812.208 8 7.0 0.68 08.812.209 9 8.0 0.81 08.812.210 10 9.0 0.94 08.812.211 11 10.0 1.08 08.812.212 12 11.0 1.24 08.812.213 13 12.0 1.40 08.812.214 14 13.0 1.56 08.812.215 15 14.0 1.73 08.812.216 16 15.0 1.89 08.812.217 17 16.0 2.05 All spacers have 5 lordotic angle, except the 7 mm heights, which are parallel. * Approximate autograft volume that T-PAL spacers can hold. Note: For additional information, please refer to package insert. For detailed cleaning and sterilization instructions, please refer to http://www.synthes.com/sites/na/medicalcommunity/pages/ Cleaning_and_Sterilization.aspx or to the below listed inserts, which will be included in the shipping container: Processing Synthes Reusable Medical Devices Instruments, Instrument Trays and Graphic Cases DJ1305 Processing Non-sterile Synthes Implants DJ1304 Synthes 7
Indications and Contraindications Intended Use The T-PAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the T-PAL Spacer should be packed with autogenous bone graft (i.e., autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment. The T-PAL Spacer is intended to be used with Synthes supplemental fixation, e.g., TSLP, ATB, Antegra, Synthes USS (including MATRIX, USS Small Stature, Click X, Pangea, USS Polyaxial, USS Iliosacral, and ClampFix). Contraindications Use of the Synthes T-PAL Spacer implant 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 stresses on bone and implants, such as severe obesity or degenerative diseases, are relative contraindications. The decision whether to use these devices in patients with such 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. These patients may place undue stresses on the implant during bony healing and may be at higher risk of implant failure. Prior fusion at the level(s) to be treated. Any condition not described in the indications for use. Please refer to the package insert for the full list of indications, contraindications, warnings and/ or precautions. 8 Synthes T-PAL Spacer System
Synthes Spine 1302 Wrights Lane East West Chester, PA 19380 Telephone: (610) 719-5000 To order: (800) 523-0322 Fax: (610) 251-9056 Synthes (Canada) Ltd. 2566 Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) 567-0440 To order: (800) 668-1119 Fax: (905) 567-3185 www.synthes.com 2011 Synthes, Inc. or its affiliates. All rights reserved. Click X, Pangea and Synthes are trademarks of Synthes, Inc. or its affiliates. Printed in U.S.A. 9/11 J10120-B