# K982936: Osteonics Extended Femoral Bearing Head

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Oct 21, 1998 after 61 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.
56 later devices descend from it; 1 cites it directly.
0 of 57 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® Morse Taper Heads: named in the summary without a submission number
- (no number) Osteonics® C-Taper Heads: named in the summary without a submission number
- (no number) DePuy Articule-Eze® Total Hip Balls: named in the summary without a submission number

## Most influential descendants
- K021310: 36MM C-Taper Femoral Head Components (Lfit and Non-Lfit) (2002), 55 descendants of its own
- K061434: Trident Large Diameter Hip System (2006), 54 descendants of its own
- K110290: Exeter Hip Stem (2011), 37 descendants of its own
- K153345: Stryker Orthopaedics Hip Systems Labeling Update (2016), 17 descendants of its own
- K093363: Cocr and Oxinium Femoral Heads and R3 Xlpe Liners (2010), 16 descendants of its own

## Indications for use
The Osteonics® Extended Femoral Bearing Heads are intended for single use in patients requiring either a Total Hip Replacement or Hemi- or Bipolar Hip Replacement. The Osteonics® Extended Femoral Bearing Heads are designed to accommodate a patient population requiring extended offset provided by a plus 12.5mm or a plus 15mm femoral head option when used in conjunction with the Osteonics® Femoral Stems specified in this submission. Indications: For use as a Bipolar or Hemi-Hip R;bglacement: ® Femoral head/neck fractures or non-unions. ® Aseptic necrosis of the femoral head. ® Osteo-, theumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion. Other considerations for use as a Bipolar or Hemi-Hip Replacement: e 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. For use as a Total Hip Replacement: e 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.

Source page: https://510kreport.com/device/K982936
Methodology: https://510kreport.com/methodology