# K013676: Trident Hemispherical Acetabular Shells

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Dec 5, 2001 after 28 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K941141 (1994). 21 ancestors in all.
68 later devices descend from it; 5 cite it directly.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001448: Trident Acetabular Shells: PS-HA, Howmedica Osteonics Corp. (2000) Summary page 1.
- K001449: Trident Acetabular Shells: PS, Howmedica Osteonics Corp. (2000) Summary page 1.
- K943054: Osteonics Secure-Fit AD Acetabular Component System, Osteonics Corp. (1994) Summary page 1.
- K942900: Osteonics Secure-Fit AD-HA Acetabular Component System, Osteonics Corp. (1995) Summary page 1.

## Most influential descendants
- K081171: Tritanium Acetabular Shell System (2008), 61 descendants of its own
- K040412: Trident T Acetabular Shells (2004), 23 descendants of its own
- 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

## Recalls of this device
- Jan 21, 2008 · Not classified · Z-1174-2008: Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals.
- Jan 21, 2008 · Not classified · Z-1170-2008: Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals.
- Jan 21, 2008 · Not classified · Z-1168-2008: Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals.
- Jan 21, 2008 · Not classified · Z-1172-2008: Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals.
- Jan 21, 2008 · Not classified · Z-1173-2008: Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals.
- Jan 21, 2008 · Not classified · Z-1169-2008: Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals.
- Jan 21, 2008 · Not classified · Z-1171-2008: Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals.
- May 29, 2007 · Not classified · Z-1685-2009: Stryker Orthopaedics became aware that Trident Hemispherical Shells, Catalog Number 508-11-74J, are actually marked and labeled as Catalog Number 598-11-72J, Lot Code 20282301

## Indications for use
The subject Trident Acetabular Shells are single-use devices intended for cementless fixation within the prepared acetabulum. The subject acetabular shells are intended for use with mating Trident Polyethylene Cup Inserts. Indications: . 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 is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Source page: https://510kreport.com/device/K013676
Methodology: https://510kreport.com/methodology