# K222056: Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics
- Decided: Jan 26, 2023 after 198 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K023087 (2002). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023087: Global Modular Replacement System (GMRS), Howmedica Osteonics Corp. (2002) Summary page 4.

## Most influential descendants
- K251665: Triathlon® Hinge Knee System (2025), 2 descendants of its own
- K233261: Global Modular Replacement System (2023), 1 descendant of its own
- K261898: Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System (2026), 0 descendants of its own
- K252898: Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper (2025), 0 descendants of its own
- K241716: Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component (2024), 0 descendants of its own

## Recalls of this device
- Aug 5, 2024 · Class II · Z-2732-2024: A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.

## 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. Proximal femoral reconstruction secondary to: Trauma Failed previous prosthesis Tumor resection 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 The Modular Rotating Hinge Knee System is intended for use with bone cement in cases where 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 revision of a failed previous prosthesis where there is instability, with or without bone loss or inadequate soft tissue. Expanded indications include for use with bone cement in situations where there is extensive bone loss, including limb salvage procedures for severe trauma, failed previous prosthesis, and/or Oncology indications.

Source page: https://510kreport.com/device/K222056
Methodology: https://510kreport.com/methodology