Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System

{0} FDA U.S. FOOD & DRUG ADMINISTRATION August 6, 2026 Howmedica Osteonics Corp., Dba Stryker Orthopaedics Elizabeth Jodon Principal Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430 Re: K261898 Trade/Device Name: Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System Regulation Number: 21 CFR 888.3510 Regulation Name: Knee Joint Femorotibial Metal/Polymer Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KRO, JWH, MBH Dated: June 2, 2026 Received: June 5, 2026 Dear Elizabeth Jodon: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K261898 - Elizabeth Jodon Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See {2} K261898 - Elizabeth Jodon Page 3 the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, LIXIN LIU -S Lixin Liu, Ph.D Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. 510(k) Number (if known) K261898 Device Name Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System Indications for Use (Describe) Triathlon® Knee System General Total Knee Arthroplasty (TKR) Indications: - Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. - Post-traumatic loss of knee joint configuration and function. - Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. - Revision of previous unsuccessful knee replacement or other procedure. - Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture -management techniques. The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented and cemented use. The Triathlon® Total Knee System beaded and beaded with Peri-Apatite components are intended for uncemented use only. The Triathlon® All Polyethylene tibial components are indicated for cemented use only. Additional Indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components: - Ligamentous instability requiring implant bearing surface geometries with increased constraint. - Absent or non-functioning posterior cruciate ligament. - Severe anteroposterior instability of the knee joint. Additional Indications for Total Stabilizer (TS) Components: - Severe instability of the knee secondary to compromised collateral ligament integrity or function. Indications for Bone Augments: - Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss. - Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss. Additional Indications for Cone Augments: - Severe degeneration or trauma requiring extensive resection and replacement - Femoral and Tibial bone voids - Metaphyseal reconstruction The Triathlon TS Cone Augment components are intended for cemented or cementless use. FORM FDA 3881 (8/23) Page 1 of 4 PSC Publishing Services (301) 443-6740 EF {4} ## Triathlon® Hinge Knee System Triathlon® Hinge Knee System is intended to be implanted with bone cement for the following condition(s): - There is destruction of the joint surfaces, with or without significant bone deformity. - The cruciate and/or collateral ligaments do not stabilize the knee joint. - The ligaments are inadequate and/or the musculature is weak. And/or - Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue. When used with MRH femur and/or MRH tibial baseplate replacement indicated in revision of an existing prosthesis: - Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue. When used with compatible GMRS components: - Where segmental resection and/or replacement of femur and/or proximal tibia is required ## Scorpio® Total Knee System Indications for the Scorpio-Flex Cruciate Retaining Tibial Insert: - Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis - Post-traumatic loss of knee joint configuration and function - Moderate varus, valgus, or flexion deformity in which the ligaments structures can be returned to adequate function and stability - Revision of previous unsuccessful knee replacement or other procedure Indications for the Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized Insert: The Scorpio NRG Knee system components are for use in total knee arthroplasty as a result of: - Painful, disabling joint disease of the knee resulting from degenerative arthritis; rheumatoid arthritis or post-traumatic arthritis - Post-traumatic loss of knee joint configuration and function - Moderate varus, valgus, or flexion deformity in which the ligaments structures can be returned to adequate function and stability - Revision of previous unsuccessful knee replacement or other procedure Additional indications for the Posterior stabilized components include: - Ligamentous instability requiring implant bearing surface geometries with increased constraint - Absent or non-functioning posterior cruciate ligament. Indications for the Scorpio-Flex Posterior Stabilized Tibial Insert: - Painful, disabling joint disease of the knee resulting from degenerative arthritis; rheumatoid arthritis or post-traumatic arthritis - Post-traumatic loss of knee joint configuration and function; moderate varus, valgus, or flexion deformity in which the ligaments structures can be returned to adequate function and stability - Revision of previous unsuccessful knee replacement or other procedure - Ligamentous instability requiring implant bearing surface geometries with increased constraint - Absent or non-functioning posterior cruciate ligament. Indications for the Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert: The Scorpio NRG Knee system components are for use in total knee arthroplasty as a result of - Painful, disabling joint disease of the knee resulting from degenerative arthritis; rheumatoid arthritis or post-traumatic arthritis - Post-traumatic loss of knee joint configuration and function - Moderate varus, valgus, or flexion deformity in which the ligaments structures can be returned to adequate function and stability - Revision of previous unsuccessful knee replacement or other procedure Additional Indications for Posterior Stabilized Devices: - Ligamentous instability requiring implant bearing surface geometries with increased constraint - Absent or non-functioning posterior cruciate ligament FORM FDA 3881 (8/23) Page 2 of 4 PSC Publishing Services (301) 443-6740 EF {5} Indications for the Osteonics Scorpio Universal Dome Patella: - Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis - Post-traumatic loss of knee joint configuration and function - Moderate varus, valgus, or flexion deformity in which the ligaments structures can be returned to adequate function and stability - Revision of previous unsuccessful knee replacement or other procedure Indications for the Scorpio Total Stabilizer Insert: General TKR Indications - Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis - Post-traumatic loss of knee joint configuration and function - Moderate varus, valgus, or flexion deformity in which the ligaments structures can be returned to adequate function and stability - Revision of previous unsuccessful knee replacement or other procedure Additional Indications for Posterior Stabilized (PS) or Total Stabilized (TS) Components: - Ligamentous instability requiring implant bearing surface geometries with increased constraint - Absent or non-functioning posterior cruciate ligament - Severe anteroposterior instability of the knee joint - For Total Stabilizer (TS) Components Only: Severe instability of the knee secondary to compromised collateral ligament integrity or function Indications for Bone Augmentation Wedges: - Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss - Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss FORM FDA 3881 (8/23) Page 3 of 4 PSC Publishing Services (301) 443-6740 EF {6} Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (8/23) Page 4 of 4 PSC Publishing Services (301) 443-6740 EF {7} K261898 # **510(k) Summary** **Sponsor** Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430 **Contact Person** Elizabeth Jodon Principal Regulatory Affairs Specialist Howmedica Osteonics Corp 325 Corporate Drive Mahwah, NJ 07430 elizabeth.jodon@stryker.com **Alternate Contact** Ka Zoua Xiong Regulatory Affairs Consultant Howmedica Osteonics Corp 325 Corporate Drive Mahwah, NJ 07430 kazoua.xiong@stryker.com **Date Prepared:** 04-August-2026 **Proprietary Name:** Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System **Common Name:** Artificial Knee Replacement Components – Tibial Inserts and All Poly Tibial Components **Classification Name:** Knee joint femorotibial metal/polymer constrained cemented prosthesis (21 CFR §888.3510) Knee joint patellofemorotibial polymer/metal/polymer semi- constrained cemented prosthesis (21 CFR §888.3560) Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis (21 CFR §888.3565) **Primary Product Code:** KRO Page 1 of 8 {8} K261898 Subsequent Product Codes: JWH, MBH Legally Marketed Primary Predicate Device to Which Substantial Equivalence is Claimed: Primary predicate: K242831 Device Name: Triathlon Knee System Product Code: JWH Legally Marketed Additional Predicate Device Used to Support Substantial Equivalence: | Device | Previous Premarket Notifications | | --- | --- | | **Triathlon® Knee System** | | | Tibial Inserts | | | Triathlon® Tibial Bearing Insert - CR (Cruciate Retaining Insert) | K040267 K042883 K141056 K172326 K173849 K201343 K242831 | | Triathlon® Tibial Bearing Insert - CS (Condylar Stabilizing Insert) | K063423 K141056 K172326 K173849 K201343 K242831 | | Triathlon® Tibial Bearing Insert - PS (Posterior Stabilized Insert) | K031729 K050539 K141056 K173849 K172326 K201343 K242831 | | Triathlon® All Poly Tibial Component - CS (Condylar Stabilizing Insert) | K123166 K141056 K172326 K201343 K242831 | | Triathlon® All Poly Tibial Component - PS (Posterior Stabilized Insert) | K123166 K141056 K172326 K201343 K242831 | | **Triathlon® Hinge Knee System** | | | Hinge Knee Tibial Components | | | Triathlon® Bushing and Axle STD | K230416 K251665 | | Triathlon® Hinge Insert with Sleeve | K223528 K230416 K251665 | | **Scorpio® Total Knee System** | | | Tibial Inserts | | | Scorpio-Flex™ Posterior Stabilized Tibial Insert | K041591 K243817 | | Scorpio-Flex™ Cruciate Retaining Tibial Insert | K011643 K243817 | | Scorpio® NRG® Tibial Bearing Insert – Cruciate Retaining Insert | K042343 K243817 | | Scorpio® NRG® Tibial Bearing Insert – Posterior Stabilized Insert | K030978 K243817 | Legally Marketed Reference Devices Used to Support scientific methodology or standard reference values in terms of testing and labeling in the Magnetic Resonance (MR) Environment: K242831 – Triathlon® Knee System and K230416 – Triathlon® Hinge Knee System. Page 2 of 8 {9} K261898 The Scorpio Total Knee System has not been evaluated for safety and compatibility in the MR environment." Legally Marketed Reference Devices Used to Support scientific methodology or standard reference values in terms of Packaging Configuration Update: K252898 - Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper. ### Rationale for Bundling: The change proposed is related to updating the packaging configuration of the Ultra High Molecular Weight Polyethylene (UHMWPE) knee devices that are packaged in a Nitrogen Vacuum (N₂Vac) environment. The same proposed packaging configurations may be used among multiple generic product types, and the same supporting data can be used across all product types. In all testing performed to support the proposed packaging change, worst-case devices, representative of all products, were used. Therefore, the testing data represents all products currently bundled in the subject 510(k) submission. ### Device Description: The devices covered by this Traditional 510(k) Premarket Notification are Stryker Ultra High Molecular Weight Polyethylene (UHMWPE) knee devices (Tibial Inserts and All-Poly Tibial Components) that are packaged in a Nitrogen Vacuum (N₂Vac) environment. The packaging for these devices consists of an impermeable foil pouch in a Polyethylene Terephthalate Glycol (PETG) blister sealed with a Tyvek lid. All subject devices are commercially available and have been found to be substantially equivalent in previous 510(k)s. ### Intended Use: The subject devices have the same intended use as those specified in the 510(k) submissions for the predicate devices listed. In general, these devices are intended for use in primary or revision knee arthroplasty. ### Indications: Triathlon® Knee System General Total Knee Arthroplasty (TKR) Indications: - Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. - Post-traumatic loss of knee joint configuration and function. Page 3 of 8 {10} K261898 - Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. - Revision of previous unsuccessful knee replacement or other procedure. - Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture - management techniques. The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented and cemented use. The Triathlon® Total Knee System beaded and beaded with Peri-Apatite components are intended for uncemented use only. The Triathlon® All Polyethylene tibial components are indicated for cemented use only. Additional Indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components: - Ligamentous instability requiring implant bearing surface geometries with increased constraint. - Absent or non-functioning posterior cruciate ligament. - Severe anteroposterior instability of the knee joint. Additional Indications for Total Stabilizer (TS) Components: - Severe instability of the knee secondary to compromised collateral ligament integrity or function. Indications for Bone Augments: - Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss. - Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss. Additional Indications for Cone Augments: - Severe degeneration or trauma requiring extensive resection and replacement - Femoral and Tibial bone voids - Metaphyseal reconstruction The Triathlon TS Cone Augment components are intended for cemented or cementless use. Triathlon® Hinge Knee System Triathlon® Hinge Knee System is intended to be implanted with bone cement for the following condition(s): - There is destruction of the joint surfaces, with or without significant bone deformity. - The cruciate and/or collateral ligaments do not stabilize the knee joint. - The ligaments are inadequate and/or the musculature is weak. And/or - Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue. Page 4 of 8 {11} K261898 When used with MRH femur and/or MRH tibial baseplate replacement indicated in revision of an existing prosthesis: - Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue. When used with compatible GMRS components: - Where segmental resection and/or replacement of femur and/or proximal tibia is required. # Scorpio® Total Knee System Indications for the Scorpio-Flex Cruciate Retaining Tibial Insert: - Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis - Post-traumatic loss of knee joint configuration and function - Moderate varus, valgus, or flexion deformity in which the ligaments structures can be returned to adequate function and stability - Revision of previous unsuccessful knee replacement or other procedure Indications for the Scorpio NRG Tibial Bearing Insert – Posteriorly Stabilized Insert: The Scorpio NRG Knee system components are for use in total knee arthroplasty as a result of: - Painful, disabling joint disease of the knee resulting from degenerative arthritis; rheumatoid arthritis or post-traumatic arthritis - Post-traumatic loss of knee joint configuration and function - Moderate varus, valgus, or flexion deformity in which the ligaments structures can be returned to adequate function and stability - Revision of previous unsuccessful knee replacement or other procedure Additional indications for the Posterior stabilized components include: - Ligamentous instability requiring implant bearing surface geometries with increased constraint - Absent or non-functioning posterior cruciate ligament. Indications for the Scorpio-Flex Posterior Stabilized Tibial Insert: - Painful, disabling joint disease of the knee resulting from degenerative arthritis; rheumatoid arthritis or post-traumatic arthritis - Post-traumatic loss of knee joint configuration and function; moderate varus, valgus, or flexion deformity in which the ligaments structures can be returned to adequate function and stability - Revision of previous unsuccessful knee replacement or other procedure - Ligamentous instability requiring implant bearing surface geometries with increased constraint - Absent or non-functioning posterior cruciate ligament. Indications for the Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert: Page 5 of 8 {12} K261898 The Scorpio NRG Knee system components are for use in total knee arthroplasty as a result of - Painful, disabling joint disease of the knee resulting from degenerative arthritis; rheumatoid arthritis or post-traumatic arthritis - Post-traumatic loss of knee joint configuration and function - Moderate varus, valgus, or flexion deformity in which the ligaments structures can be returned to adequate function and stability - Revision of previous unsuccessful knee replacement or other procedure Additional Indications for Posterior Stabilized Devices: - Ligamentous instability requiring implant bearing surface geometries with increased constraint - Absent or non-functioning posterior cruciate ligament. Indications for the Osteonics Scorpio Universal Dome Patella: - Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis - Post-traumatic loss of knee joint configuration and function - Moderate varus, valgus, or flexion deformity in which the ligaments structures can be returned to adequate function and stability - Revision of previous unsuccessful knee replacement or other procedure Indications for the Scorpio Total Stabilizer Insert: General TKR Indications - Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis - Post-traumatic loss of knee joint configuration and function - Moderate varus, valgus, or flexion deformity in which the ligaments structures can be returned to adequate function and stability - Revision of previous unsuccessful knee replacement or other procedure Additional Indications for Posterior Stabilized (PS) or Total Stabilized (TS) Components: - Ligamentous instability requiring implant bearing surface geometries with increased constraint - Absent or non-functioning posterior cruciate ligament - Severe anteroposterior instability of the knee joint - For Total Stabilizer (TS) Components Only: Severe instability of the knee secondary to compromised collateral ligament integrity or function Indications for Bone Augmentation Wedges: - Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss - Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss **Summary of Technological Characteristics:** Page 6 of 8 {13} K261898 The subject devices are substantially equivalent in intended use, indications for use, product design, product materials, and operational principles to their corresponding predicates. The only difference between the subject devices and corresponding predicate devices is their packaging configurations. The packaging components of the predicate devices contain an inner and outer blister of Barex \( ^{a} \) Modified Acrylonitrile copolymer sealed with inner and outer foil lids purged with alternating vacuum and nitrogen (N \( _{2} \) Vac). The packaging of the subject devices consist of an impermeable foil pouch in a Polyethylene Terephthalate Glycol (PETG) blister sealed with a Tyvek lid followed by vacuum and nitrogen (N \( _{2} \) Vac) purging. ### Non-Clinical Testing: The following non-clinical laboratory testing was performed to determine substantial equivalence: Studies were performed on the subject UHMWPE knee devices to evaluate the effect of the proposed packaging modifications. The studies compared the following material properties of the subject UHMWPE devices for the proposed and current packaging configurations: • Small Punch per ASTM F2977 - Oxygen Content - Oxidation Index per ASTM F2102 Design Verification Distribution (ship) and Packaging Performance testing were completed on the subject devices to qualify the proposed packaging configurations. Testing was completed per ISO 11607-1, ASTM F88 / F88M, and ASTM F2096. Accelerated Aging studies were completed to validate a shelf-life of five (5) years (inclusive of final month) for the subject devices marketed as STERILE per ISO 11607-1, ISO 11607-2, and ASTM F1980. Product endotoxin and cytotoxicity testing were executed as the proposed packaging configuration constitutes a change in packaging materials that contact the product after final cleaning. Endotoxin testing was completed per AAMI ST72, and cytotoxicity testing was completed per ISO 10993-5. ### Clinical Testing: Clinical testing was not required as a basis for substantial equivalence. ## Conclusion: Page 7 of 8 {14} K261898 Based upon a comparison of the intended use, indications for use, design, material, sterilization method, technical and performance characteristics, and operational principles, the subject devices are substantially equivalent to the predicate devices identified in this Premarket Notification. Page 8 of 8