# K971422: Osteonics Acetabular Wedge System

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: May 22, 1997 after 35 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
22 later devices descend from it; 1 cites it directly.
0 of 23 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) MARS (Modular Acetabular Reconstruction System) Device: named in the summary without a submission number
- (no number) Osteonics® Secur-Fit™ HA Acetabular Shells: named in the summary without a submission number

## Most influential descendants
- K102019: Restoration Acetabular Wedge Augments (2011), 21 descendants of its own
- K153345: Stryker Orthopaedics Hip Systems Labeling Update (2016), 17 descendants of its own
- K173499: Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads (2018), 8 descendants of its own
- K182468: Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System (2019), 7 descendants of its own
- K220731: Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem (2022), 6 descendants of its own

## Indications for use
The Osteonics® Acetabular Wedges because they are accessory components to an existing total hip replacement system, are subject to the general indications of their mating acetabular shell components, as follows: General Indications for Total Hip Replacement Components Painful, disabling joint disease of the hip resulting from degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum. Indications Specific to the Acetabular Wedges As an alternative to structural allograft in cases of superior and superior/posterior segmental acetabular deficiencies. The assembled acetabular wedge-to-shell construct can be affixed to the acetabulum either with or without bone cement, according to the specific fixation methods already determined substantially equivalent by FDA for the commercially available, mating acetabular shell components.

Source page: https://510kreport.com/device/K971422
Methodology: https://510kreport.com/methodology