# K233261: Global Modular Replacement System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
- Decided: Dec 8, 2023 after 70 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K023087 (2002). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222056: Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2023) Summary page 9.

## Most influential descendants
- K241716: Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component (2024), 0 descendants of its own

## Indications for use
This device is intended for use in patients requiring extensive reconstruction of the femur and/or proximal tibia, including the hip or knee joint, resulting from extensive bone loss. Tumor resection for skeletal lesions (Oncology patients where radical bone resection and replacement may be required), revision surgery for failed arthroplasty, and acute trauma are the primary causes of extensive bone loss. These prostheses are intended for use with bone cement. The Intercalary System is intended for use in situations arising from in femoral mid-shaft tumor resection, or for prosthetic knee fusion. Femoral and/or proximal tibial replacement and total femoral replacement in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of the bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. Femoral replacement in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. This component may also be used with the Distal Femoral segment components of the GMRS in total femoral replacement. Femoral and/or proximal tibial replacement due to: Trauma Failed previous prosthesis Tumor resection

Source page: https://510kreport.com/device/K233261
Methodology: https://510kreport.com/methodology