# K023087: Global Modular Replacement System (GMRS)

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Dec 16, 2002 after 90 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
29 later devices descend from it; 12 cite it directly.
0 of 30 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 its predicate without a number.
- (no number) Modular Replacement System: named in the summary without a submission number
- (no number) Distal Stems of the Restoration Hip System: named in the summary without a submission number
- (no number) Modular Rotating Hinge Knee System: named in the summary without a submission number
- (no number) Kinematic Rotating Hinge Knee System: named in the summary without a submission number
- (no number) MOST System: named in the summary without a submission number

## Most influential descendants
- K092138: JTS Extendeable Implant (2011), 7 descendants of its own
- K222056: Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee (2023), 5 descendants of its own
- K151008: Link® Megasystem-C® (2015), 4 descendants of its own
- K181778: MUTARS Proximal Femur Replacement System (2019), 3 descendants of its own
- K121029: Mets Modular Distal Femur (2012), 3 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.
- May 5, 2005 · Not classified · Z-2624-2010: Mislabeled package: Package labeled as GMRS Extension Piece 60 mm, lot ZYCOC1 actually contains a GMRS Extension Piece 70 mm extension piece.

## Indications for use
The Global Modular Replacement System (herein referred to as the GMRS) is intended to be used with the components of Howmedica Osteonics' Modular Replacement System, Modular Rotating Hinge Knee System, and/or Kinematic Rotating Hinge Knee System in situations where replacement of extensive bone loss in the femur and/or proximal tibia is required. The Proximal Femoral Module and Distal Femoral Module of the GMRS may be used together, or with the components of the MRS, in replacement of the total femur. Indications and contraindications for this type of replacement are listed below: Femoral and/or proximal tibial replacement and total femoral replacement in Omology 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.

Source page: https://510kreport.com/device/K023087
Methodology: https://510kreport.com/methodology