# K954598: Osteonics Offset Hip Stems

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Apr 4, 1996 after 184 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
No predicates in its family tree.
20 later devices descend from it; 1 cites it directly.
0 of 21 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) Osteonics® Omnifit® Plus Cemented Hip Stems: named in the summary without a submission number
- (no number) Osteonics® ODC Hip Stems: named in the summary without a submission number
- (no number) Osteonics® Restoration Cemented Hip Stems: named in the summary without a submission number

## Most influential descendants
- K031744: Omnifit HFX Hip Stem Series (2003), 19 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
- K211703: Insignia Hip Stem (2021), 7 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

## Indications for use
The Osteonics® Offset Hip Stems are intended for single use in patients requiring either a Total Hip Replacement or a Hemi- or Bipolar Hip Replacement. The Osteonics® Offset Hip Stems are intended to be implanted in cemented or cementless applications. The specific intended uses of the Osteonics® Offset Hip Stems include the following: % head/neck mg or non-unions. Aseptic necrosis of the femoral head. Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion. Other considerations for use as a Bipolar or Hemi-Hip Replacement. Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum. Salvage of failed total hip arthroplasty. Painful, i g 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.

Source page: https://510kreport.com/device/K954598
Methodology: https://510kreport.com/methodology