# K050937: Trabecular Metal Acetabular Revision Shells

- Pathway: 510(k) (Special)
- Applicant: Zimmer Trabecular
- Decided: May 11, 2005 after 27 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
No predicates in its family tree.
14 later devices descend from it; 2 cite it directly.
0 of 15 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 no predicate by number.

## Most influential descendants
- K150790: REDAPT Porous Acetabular Shell and Cemented Liner (2015), 13 descendants of its own
- K171073: Smith & Nephew, Inc. REDAPT Augments (2017), 5 descendants of its own
- K182109: REDAPT Modular Acetabular Shell (2018), 4 descendants of its own
- K160923: REDAPT Anteverted Cemented Liner (2016), 4 descendants of its own
- K211176: Smith & Nephew Hip Systems (2022), 3 descendants of its own

## Indications for use
The Indications for Use of the Trabecular Metal Acetabular Revision Shells are: For cemented or cementless use. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis or late stage avascular necrosis. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. Clinical management problem where arthrodesis or alternative reconstruction techniques are less likely to achieve satisfactory results. Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Source page: https://510kreport.com/device/K050937
Methodology: https://510kreport.com/methodology