# K052917: Stryker Compartmental Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Dec 27, 2005 after 71 days
- Product code: NPJ (Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
178 later devices descend from it; 5 cite it directly.
0 of 179 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K070695: Zimmer Patellofemoral Joint Prosthesis (2007), 122 descendants of its own
- K073286: Gender Solutions Natural-Knee Flex System (2008), 117 descendants of its own
- K113369: Zimmer Persona Knee System (2012), 96 descendants of its own
- K061648: Depuy Graduated Compartmental Knee (GCK) (2006), 61 descendants of its own
- K121771: Zimmer Persona the Personalized Knee System (2012), 59 descendants of its own

## Recalls of this device
- Jul 30, 2026 · Class II · Z-3206-2026: Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which m
- Dec 1, 2023 · Class II · Z-0893-2024: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Dec 1, 2023 · Class II · Z-0895-2024: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Dec 1, 2023 · Class II · Z-0896-2024: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Dec 1, 2023 · Class II · Z-0897-2024: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Dec 1, 2023 · Class II · Z-0900-2024: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Dec 1, 2023 · Class II · Z-0894-2024: Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
- Aug 17, 2011 · Not classified · Z-0606-2012: Two National Joint Registries suggest that the EIUS Unicompartmental System is associated with a higher revision rate then the unicompartmental devices.

## Indications for use
The Stryker® Compartmental Knee System is intended to be used in cemented patellofemoral and/or unicondylar arthroplasty in patients where conditions exist that cannot be addressed by a single device to treat the femorotibial or patellofemoral regions of the knee. The indications for the different components of the Stryker® Compartmental Knee System include conditions when the patellofemoral and/or condylar region(s) have been affected by one or more of the tollowing conditions: * Degenerative arthritis in the distal femur and patella, * Patients with a history of patellar dislocation or patella fracture, * Patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists, * Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis, * Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis, * As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis, or Vhere bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the femoral condyle/tibial plateau. These components are single use only and are intended for implantation with bone cement.

Source page: https://510kreport.com/device/K052917
Methodology: https://510kreport.com/methodology