# K103124: Series II X3 Large Diameter Accetabular Inserts

- Pathway: 510(k) (Special)
- Applicant: Stryker Corporation
- Decided: Nov 19, 2010 after 28 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002575 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052748: System 12 X3 Acetabular Inserts; Series II X3 Acetabular Inserts, Howmedica Osteonics Corp. (2005) Summary page 2.
- K062419: Trident Large Diameter Acetabular Inserts, Howmedica Osteonics Corp. (2006) Summary page 2.

## Indications for use
The Series II X3® Large Diameter Acetabular Inserts are single use sterile components, intended for use in conjunction with an associated Howmedica Osteonics metal acetabular shell, femoral bearing, and femoral hip stem as part of a cemented or cementless total hip arthroplasty. The indications for use of total hip replacement prostheses include: 1) Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis. 2) Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. 3) Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. 4) 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/K103124
Methodology: https://510kreport.com/methodology