ORTHOLOC CROSSCHECK TECHNOLOGY OVERVIEW FOR HOSPITAL VALUE ANALYSIS COMMITTEE

Transcription

1 ORTHOLOC CROSSCHECK TECHNOLOGY OVERVIEW FOR HOSPITAL VALUE ANALYSIS COMMITTEE

2 Indications for Use The ORTHOLOC 3Di Foot Reconstruction System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet. Specific examples include: Mid / Hindfoot Fusions LisFranc Arthrodesis and/or Stabilization 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions Intercuneiform Fusions Navicular-Cuneiform (NC) Fusion Talonavicular (TN) Fusion Calcaneo-Cuboid (CC) Fusion Medial Column Fusion First metatarsal osteotomies for hallux valgus correction including: Opening base wedge osteotomy Closing base wedge osteotomy Crescentic osteotomy Proximal Chevron osteotomy Distal Chevron osteotomy (Austin) First metatarsal fracture fixation Arthrodesis of the first metatarsal cuneiform joint (Lapidus Fusion) Arthrodesis of the first metatarsophalangeal joint (MTP) including: Primary MTP Fusion due to hallux rigidus and/or hallux valgus Revision MTP Fusion Revision of failed first MTP Arthroplasty implant Flatfoot Osteotomies Lateral Column Lengthening (Evans Osteotomy) Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy) HCPCS Device Codes Disclaimer The coding and reimbursement information and data provided by Wright Medical is presented for informational purposes only and is accurate as of its date of publication. It is the provider s responsibility to report the codes that accurately describe the products and services furnished to individual patients. Reimbursement is dynamic. Laws and regulations regarding reimbursement change frequently and providers are solely responsible for all decisions related to coding and billing including determining, if and under what circumstances, it is appropriate to seek reimbursement for products and services and obtaining pre-authorization, if necessary. For these reasons, providers are advised to contact Medicare and/or specific payers if they have any questions regarding billing, coverage and payment. Likewise, providers should contact a medical specialty society or the AMA for coding clarification. Providers should check the complete and current HCPCS and/or CPT manual to see and consider all possible HCPCS and/ or CPT codes. Wright Medical makes no representation or warranty regarding this information or its completeness or accuracy and will bear no responsibility for the results or consequences of the use of this information. To view codes for ORTHOLOC 3Di CROSSCHECK, visit the reimbursement page at

3 How do you make a great system better? ORTHOLOC 3Di Foot Reconstruction System The ORTHOLOC 3Di Foot Reconstruction System is a multi-indication foot reconstruction solution providing indication specific implants and instruments designed to address the unique demands of the forefoot and midfoot. Each ORTHOLOC 3Di implant has been designed with a focus on strength, versatility, and low profile anatomic contours. Additionally, the employment of the ORTHOLOC 3Di Polyaxial Locking Technology allows the surgeon the option of 2.7mm or 3.5mm locking screws capable of locking at up to 15 off axis to the plate. MTP Fusion Plate Lapidus Fusion Plate Medial Displacement Calcaneal Osteotomy (MDCO) Plate N/C Plate BOW Opening Wedge Plate 1st Metatarsal Plate Medial Column Plate Cotton Osteotomy Plate Evans Osteotomy Plate T - Plate Straight Plate U - Plate By adding ORTHOLOC 3Di CROSSCHECK The ORTHOLOC 3Di CROSSCHECK Plating System is a modular addition comprised of 5 uniquely designed plates which offer an inter-fragmentary or cross screw through the plate solution. The new module expands the overall capabilities of the ORTHOLOC 3Di Foot Reconstruction Plating System which enables surgeons and hospitals to confidently and efficiently treat their patients. MTP Plate Lapidus Plate 0mm Lapidus Plate 2mm Y-Plate Utility Plate 5 Hole 3.5mm Partially Threaded Cross Screw STRENGTH / VERSATILITY / LOW PROFILE ANATOMIC CONTOURS

4 ORTHOLOC 3Di Foot Reconstruction System Unsurpassed Surgical Versatility Innovative, Low Profile Designs for Unique Demands Precise Correction Strength, Rigidity, and Tapered Implant Contours with Soft Angles for Minimal Soft Tissue Complication Dynamic Compression S T R E N G T H V E R S A T I L I T Y

5 Customized Configuration for Every Surgery Build the kit with any module you need Lapidus BOW / First Ray MTP Medial Column Midfoot Flatfoot MDCO New Addition: 3Di CROSSCHECK L O W P R O F I L E A N A T O M I C C O N T O U R S

6 ORTHOLOC 3Di CROSSCHECK A new module within the ORTHOLOC 3Di Foot Reconstruction platform that further expands surgical plating options while minimizing trays per procedure. This is a unique solution that is different by design. Low Profile, Anatomic Plate Designs Joint Line for Placement MTP and Lapidus 0mm only Type II Anodized Titanium Alloy Plates Tapered Contours and Soft Angles to minimize soft tissue complication Utilizes 2.7mm and 3.5mm (Locking and Non-locking Screws) Dynamic, Mechanical Compression Generated by Cross-Joint Lag Screw All Plates Feature 3Di Polyaxial Locking Technology S T R E N G T H V E R S A T I L I T Y

7 Why are the plates TYPE II Anodized? MTP Plate The plates are gray in color because they are TYPE II Anodized Titanium Alloy plates, which offers better strength in fatigue compared to color anodized and stainless steel plates TYPE II Anodized Load Material Fatigue Strength* Color Anodized Load Stainless Steel Load 60% Greater 20% Greater Lapidus Plate 0mm Lapidus Plate 2mm Type II Anodized Color Anodized Stainless Steel * Internal data on file ASTM 136 ASTM 136 ASTM 138 Fatigue Strength at 10 million Cycles Y-Plate CrossGrip ridges designed for powerful purchase Utility Plate 5 Hole Cross-joint compression facilitated by a 3.5mm non-locking Cross Screw Conical Tip 2/3 threaded 1/3 smooth 3.5mm diameter T8 Hex 1mm thread pitch L O W P R O F I L E A N A T O M I C C O N T O U R S

8 General Goals of Foot & Ankle Surgery Reduce or correct foot deformity Reduce pain Preserve or improve function Facilitate a return to daily activities Leading Procedures and Pathologies Treated by ORTHOLOC 3Di Foot Reconstruction System Tarso- Metatarsal Fusions Lapidus Arthrodesis MTP Joint Arthrodesis Flatfoot Osteotomies Revisions of Primary Fusions or Arthroplasty Utility Plate 5 Hole for TMT Fusions ORTHOLOC 3Di CROSSCHECK Y-Plate for TMT Fusions MTP Plate for 1st MTP Fusions Lapidus Plate for Lapidus Arthrodesis S T R E N G T H V E R S A T I L I T Y

9 Medical Education and Training for Surgeons and Hospital Staff Wright Medical offers hospital staff a number of training opportunities on safe and effective use of our products, including training on technologies, pathologies, procedures, and processes. Surgeon education and training events are offered through the year at various locations featuring the ORTHOLOC 3Di Plating System. In-service training on Wright products is available through WRIGHT Medical sales representatives. Training includes, but is not limited to, the following: Intended medical use of the system Expedient identification of implants and instruments in the sets Correct assembly and disassembly of instruments, and cleaning and sterilization procedures Surgeons and hospital staff will also be provided with ORTHOLOC 3Di Foot Plating System surgical techniques and other technology materials for review. Please contact your local Wright Medical sales representative for more information. Please refer to the package insert for information on sterilization, cleaning, and handling Wright Medical instruments that can be found at L O W P R O F I L E A N A T O M I C C O N T O U R S

10 Product Ordering Information To order the ORTHOLOC 3Di Foot Reconstruction System, contact your local Wright Medical sales representative. Below is a list of implant modules and instrumentation available for order within the ORTHOLOC 3Di Foot Reconstruction System. MTP Plate Y-Plate 5886KITH/2 must be ordered with 5885KITA/1 and 5886KITA/1 Lapidus Plate 0mm Utility Plate 5 Hole Lapidus Plate 2mm ORTHOLOC 3Di CROSSCHECK Implants Kit #5886KITH 5820MPX1L MTP Plate Left MPX1R MTP Plate Right LPX0L Lapidus Plate - Neutral, Left LPX0R Lapidus Plate - Neutral, Right LPX2L Lapidus 2mm Step, Left LPX2R Lapidus 2mm Step, Right UTN5 Utility Plate 5 Hole YPX1 Y-Plate X3518 Lag Screw 3.5 x 18mm X3520 Lag Screw 3.5 x 20mm X3522 Lag Screw 3.5 x 22mm X3524 Lag Screw 3.5 x 24mm X3526 Lag Screw 3.5 x 26mm X3528 Lag Screw 3.5 x 28mm X3530 Lag Screw 3.5 x 30mm X3532 Lag Screw 3.5 x 32mm X3534 Lag Screw 3.5 x 34mm X3536 Lag Screw 3.5 x 36mm X3538 Lag Screw 3.5 x 38mm X3540 Lag Screw 3.5 x 40mm 2 ORTHOLOC 3Di CROSSCHECK Instruments Kit #5886KIT2 5820CX25 Plating System 2.5mm Screw Drill Guide PRO-TOE C2 DRIVER T8 HEX ORTHOLOC 3Di CROSSCHECK Caddy 1 S T R E N G T H V E R S A T I L I T Y

11 Product Ordering Information for Kit# 5885KITA and 5886KITA Hallux Set Kit# 5886KITA RT MTP Fusion Small 0Dg Rt RT MTP Fusion Small 5Dg Rt RT MTP Fusion Small 10Dg Rt LT MTP Fusion Small 0Dg Lt LT MTP Fusion Small 5Dg Lt LT MTP Fusion Small 10Dg Lt RT MTP Fusion Medium 0Dg Rt RT MTP Fusion Medium 5Dg Rt RT MTP Fusion Medium 10Dg Rt LT MTP Fusion Medium 0Dg Lt LT MTP Fusion Medium 5Dg Lt LT MTP Fusion Medium 10Dg Lt RT MTP Fusion Revision Rt LT MTP Fusion Revision Lt RT MTP Fusion Revision Large Rt LT MTP Fusion Revision Large Lt BOW Plate 0mm BOW Plate 2mm BOW Plate 3mm BOW Plate 4mm BOW Plate 5mm Lapidus Plate 0mm Lapidus Plate 1mm Lapidus Plate 2mm Lapidus Plate 3mm Lapidus Plate 4mm First Ray Plate Small First Ray Plate Medium 1 Midfoot Set Kit# 5886KITB R Midfoot Fusion U-Plate Sm Rt L Midfoot Fusion U-Plate Sm Lt R Midfoot Fusion U-Plate Md Rt L Midfoot Fusion U-Plate Md Lt R Midfoot Fusion U-Plate Lg Rt L Midfoot Fusion U-Plate Lg Lt R Midfoot Fusion T-Plate Rt L Midfoot Fusion T-Plate Lt Midfoot Fusion Straight Plate 1 Medial Column Set Kit# 5886KITC Medial Column Fusion Plate Sm Medial Column Fusion Plate Md Medial Column Fusion Plate Lg N/C Fusion Plate Sm N/C Fusion Plate Lg 1 Flatfoot Set Kit# 5886KITD and 5886KITF/ CLAW II Plate Tack Evans Opening Wedge Plate 0mm Evans Opening Wedge Plate 6mm Evans Opening Wedge Plate 8mm Evans Opening Wedge Plate 10mm Cotton Wedge Plate 0mm Cotton Wedge Plate 4.5mm Cotton Wedge Plate 6.5mm Cotton Wedge Plate 5.5mm MDCO Plate 1 L O W P R O F I L E A N A T O M I C C O N T O U R S

12 Product Ordering Information ORTHOLOC 3Di 2.7mm Locking Screws (Screw Color: Grey) Locking Lg Hd Screw 2.7 x 10mm Locking Lg Hd Screw 2.7 x 12mm Locking Lg Hd Screw 2.7 x 14mm Locking Lg Hd Screw 2.7 x 16mm Locking Lg Hd Screw 2.7 x 18mm Locking Lg Hd Screw 2.7 x 20mm Locking Lg Hd Screw 2.7 x 22mm Locking Lg Hd Screw 2.7 x 24mm Locking Lg Hd Screw 2.7 x 26mm Locking Lg Hd Screw 2.7 x 28mm Locking Lg Hd Screw 2.7 x 30mm 2 ORTHOLOC 2.7mm Low-Profile Screws (Screw Color: Grey) Low-Pro Cort Screw 2.7 x 10mm Low-Pro Cort Screw 2.7 x 12mm Low-Pro Cort Screw 2.7 x 14mm Low-Pro Cort Screw 2.7 x 16mm Low-Pro Cort Screw 2.7 x 18mm Low-Pro Cort Screw 2.7 x 20mm Low-Pro Cort Screw 2.7 x 22mm Low-Pro Cort Screw 2.7 x 24mm Low-Pro Cort Screw 2.7 x 26mm Low-Pro Cort Screw 2.7 x 28mm Low-Pro Cort Screw 2.7 x 30mm 2 ORTHOLOC 3Di 3.5mm Locking Screws Locking Screw 3.5 x 10mm Locking Screw 3.5 x 12mm Locking Screw 3.5 x 14mm Locking Screw 3.5 x 16mm Locking Screw 3.5 x 18mm Locking Screw 3.5 x 20mm Locking Screw 3.5 x 22mm Locking Screw 3.5 x 24mm Locking Screw 3.5 x 26mm Locking Screw 3.5 x 28mm Locking Screw 3.5 x 30mm Locking Screw 3.5 x 32mm Locking Screw 3.5 x 34mm Locking Screw 3.5 x 36mm Locking Screw 3.5 x 38mm Locking Screw 3.5 x 40mm Locking Screw 3.5 x 42mm Locking Screw 3.5 x 44mm Locking Screw 3.5 x 46mm Locking Screw 3.5 x 48mm Locking Screw 3.5 x 50mm Locking Screw 3.5 x 55mm Locking Screw 3.5 x 60mm 3 ORTHOLOC 3.5mm Low-Profile Screws Kit# 5885KIT1 (Screw Color: Purple) (Screw Color: Bronze) Low-Pro Cort Screw 3.5 x 10mm Low-Pro Cort Screw 3.5 x 12mm Low-Pro Cort Screw 3.5 x 14mm Low-Pro Cort Screw 3.5 x 16mm Low-Pro Cort Screw 3.5 x 18mm Low-Pro Cort Screw 3.5 x 20mm Low-Pro Cort Screw 3.5 x 22mm Low-Pro Cort Screw 3.5 x 24mm Low-Pro Cort Screw 3.5 x 26mm Low-Pro Cort Screw 3.5 x 28mm Low-Pro Cort Screw 3.5 x 30mm Low-Pro Cort Screw 3.5 x 32mm Low-Pro Cort Screw 3.5 x 34mm Low-Pro Cort Screw 3.5 x 36mm Low-Pro Cort Screw 3.5 x 38mm Low-Pro Cort Screw 3.5 x 40mm Low-Pro Cort Screw 3.5 x 42mm Low-Pro Cort Screw 3.5 x 44mm Low-Pro Cort Screw 3.5 x 46mm Low-Pro Cort Screw 3.5 x 48mm Low-Pro Cort Screw 3.5 x 50mm Low-Pro Cort Screw 3.5 x 55mm Low-Pro Cort Screw 3.5 x 60mm 3 S T R E N G T H V E R S A T I L I T Y

13 Product Ordering Information Intrumentation Kit# 5885KIT1 Disposables K-Wire Tissue Protector Drill Guide 2.0 / Drill Guide 2.8 / Drill Guide 3.5 / Drill Guide 2.5mm Insert Drill Guide 2.5mm Insert Drill Guide 2.8mm Insert Locking 2.0mm Drill Guide Locking 2.8mm Drill Guide Poly Locking Drill Guide Screw Gripper Depth Gauge 60mm Slotted Plate Bender Threaded Bending Iron AO Quick Connect Cannulated 1 Dc4197 Forceps Angled Tip Ratcheting Driver Handle Torque Limiting Driver Handle Core ORTHOLOC 3Di Core Tray Single Trocar Wire 1.6 x 150mm K-Wire 1.2 x 150mm Drill Bit 2.0mm x 30mm Drill Bit 2.5mm x 60mm Drill Bit 2.8mm x 60mm Drill Bit 3.5mm x 60mm Drill Bit 4.0mm x 60mm Temp Fixation Pin 1.4mm Sm Temp Fixation Pin 1.4mm Lg T15 Driver Star 15 Straight CLAW II Plate Tack 2 L O W P R O F I L E A N A T O M I C C O N T O U R S

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16 For more information visit Cherry Road Memphis, TN Quai Charles de Gaulle Lyon France +33 (0) Unit 1, Campus Five Letchworth Garden City Hertfordshire SG6 2JF United Kingdom (0) Trademarks and Registered marks of Wright Medical Group N.V. or its affiliates Wright Medical Group N.V. or its affiliates. All Rights Reserved A 01-Mar-2016