# K081171: Tritanium Acetabular Shell System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jul 22, 2008 after 89 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: 5 generations back to K941141 (1994). 24 ancestors in all.
61 later devices descend from it; 6 cite it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013676: Trident Hemispherical Acetabular Shells, Howmedica Osteonics Corp. (2001) Summary page 2.
- K010170: Trident Porous Titanium Acetabular Component, Howmedica Osteonics Corp. (2001) Summary page 2.
- K001759: Hedrocel Revision Cup, Model 02-2YY-ZZZZ, Implex Corp. (2000) Summary page 2.

## Most influential descendants
- K101072: Tritanium Peri-Apatitie Acetabular Solid-Backed Shell, Tritanium Peri-Apatite (2011), 22 descendants of its own
- K143085: Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach (2015), 21 descendants of its own
- K122158: PBP Total Hip System (2012), 21 descendants of its own
- K131237: Pipeline Total Hip System (2013), 20 descendants of its own
- K161184: iNSitu Total Hip System (2016), 19 descendants of its own

## Indications for use
The indications for use of the total hip replacement prostheses include: 1. Painful, disabling joint disease of the hip resulting from: non-inflammatory degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, or late stage avascular necrosis. 2. Revision of previous failed femoral head replacement, shell arthroplasty or other procedure. 3. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. 4. Where bone saock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum. This acetabular shell is intended for cementless use only.

Source page: https://510kreport.com/device/K081171
Methodology: https://510kreport.com/methodology