# K082567: Stryker Compartmental Knee System Line Extension

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Oct 3, 2008 after 29 days
- Product code: HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 1 cites it directly.
0 of 11 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
- K093056: Smith & Nephew, Inc. Journey Select Knee System (2009), 9 descendants of its own
- K160738: ZUK Select Knee System (2016), 8 descendants of its own
- K190085: Journey II Unicompartmental Knee System (2019), 7 descendants of its own
- K230653: Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates (2023), 3 descendants of its own
- K191211: JOURNEY II Unicompartmental Knee System (2019), 1 descendant of its own

## Indications for use
The Stryker ® Compartmental Knee System line extension is intended for use 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 line extension include conditions when the patellofemoral and/or condylar region(s) have been affected by one or more of the following 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 4 Where 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/K082567
Methodology: https://510kreport.com/methodology