# K023692: Global Modular Replacement System Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Mar 20, 2003 after 136 days
- Product code: LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Femoral Body Segments of the MRS System: named in the summary without a submission number
- (no number) T3 Femoral Component: named in the summary without a submission number

## Indications for use
The GMRS Adapter is intended to mate the Proximal Femoral Components and Femoral Bodies of the MRS or Proximal Femoral Body or Extension Pieces of the GMRS to the distal femoral stems of the Restoration Modular Hip System. The GMRS adapter is intended for use with the above-noted components in proximal femoral replacement indicated 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. Adequate bone stock must be present to allow the use of the Restoration Modular Distal Femoral Stems. Indications and contraindications of the GMRS Adapter when used with the Proximal Femoral Bodies of the MRS and GMRS, and the distal femoral stems of the Restoration Modular Hip System follow: Indications Proximal 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. Contraindications A. As related to Bone Tumors Not all bone tumors may be treated successfully by segmental resection. Any condition that may have already resulted in either local or distant spread of the tumor may be a contraindication. Examples of such conditions include: pathological fracture; overt infection; inopportune placement of biopsy incision; and, rapid disease progression beyond a respectable margin. B. As related to Failed Previous Prosthesis and Trauma Any active or suspected latent infection in or about the hip joint. Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complication in postoperative care. Bone stock compromised by disease, infection, or prior implantation that cannot provide adequate support and fixation of the prosthesis. For the use of GMRS Adapter with the Distal Stems of the Restoration Modular Hip System, the following additional contraindication should be noted: Inadequate bone stock to allow the use of a press fit stem The GMRS Adapter is intended to be used in a press fit mode.

Source page: https://510kreport.com/device/K023692
Methodology: https://510kreport.com/methodology