# K241716: Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics
- Decided: Aug 2, 2024 after 49 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: 3 generations back to K023087 (2002). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 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 6.
- K233261: Global Modular Replacement System, Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics (2023) Summary page 7.
- K023087: Global Modular Replacement System (GMRS), Howmedica Osteonics Corp. (2002) Summary page 4.
- K952970: Howmedica Femoral & Proximal Tibial Modular Replacement Sytesm, Howmedica Corp. (1996) Summary page 4.
- K032581: Global Modular Replacement System Anteverted Promimal Femoral Component, Howmedica Osteonics Corp. (2003) Summary page 4.
- K040749: Modular Replacement System Cemented Stems, Howmedica Osteonics Corp. (2004) Summary page 4.
- K022403: GMRS Press Fit Stems with Purefix HA, Howmedica Osteonics Corp. (2002) Summary page 4.
- K031217: GMRS Press Fit Stems with Purefix HA, Howmedica Osteonics (2003) Summary page 4.
- K002552: Howmedica Osteonics Modular Rotating Hinge Knee, Howmedica Osteonics Corp. (2000) Summary page 5.

## Indications for use
Indications for the MRS Stems and lntercalary Stems presented in K952970: 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 lntercalary System is intended for use in situations arising from in femoral mid-shaft tumor resection, or for prosthetic knee fusion. Indications for the Global Modular Replacement System (presented in K023087): 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. Indications for the GMRS Anteverted Proximal Femoral Component (presented in K032581 ): 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. Indications for the Global Modular Replacement System Press Fit Stems with HA Coating (presented in K022403, and K031217): Proximal femoral reconstruction secondary to: o Trauma o Failed previous prosthesis o Tumor resection Indications for the Modular Replacement System Cemented Stems (presented in K040749): Femoral and/or proximal tibial replacement due to: o Trauma o Failed previous prosthesis o Tumor resection Indications for the Modular Rotating Hinge Knee System (cleared in K002552) 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/K241716
Methodology: https://510kreport.com/methodology