# K974685: Osteonics Polyethylene Acetabular Components

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Sep 22, 1998 after 280 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: 1 (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; 4 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) Osteonics Polyethylene Acetabular Components fabricated from standard polyethylene: named in the summary without a submission number

## Most influential descendants
- K993352: Crossfire System 12 Acetabular Inserts (1999), 18 descendants of its own
- K111546: U2 Hip System (2011), 13 descendants of its own
- K150007: Modified Bencox Hip System (2015), 7 descendants of its own
- K122185: U-Motion II Acetabular System (2013), 7 descendants of its own
- K162127: Bencox M Stem Lateralized & Bencox Mirabo Cup System (2016), 6 descendants of its own

## Recalls of this device
- Nov 7, 2019 · Class II · Z-0811-2020: May have a missing locking wire causing delay in surgery while retrieving a back-up device or implantation of a device that is missing a locking wire

## Indications for use
Osteonics® Crossfire™ Polyethylene Acetabular Components are single use components, intended for use in conjunction with an associated Osteonics® metal acetabular shell, femoral bearing, and femoral hip stem, as part of a cemented or cementless total hip arthroplasty. Indications for use, in keeping with those of other commercially available Class II total hip devices, are as follows: 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 inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Source page: https://510kreport.com/device/K974685
Methodology: https://510kreport.com/methodology