# K983502: Osteonics Secur-Fit AD Generation II Acetabular Component System

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Dec 16, 1998 after 71 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- 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.
72 later devices descend from it; 5 cite it directly.
0 of 73 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® Secur-Fit™-AD Acetabular Components: named in the summary without a submission number
- (no number) Osteonics® Modular Acetabular Cup System: named in the summary without a submission number
- (no number) Osteonics® Omnifit® Series II Cup Inserts: named in the summary without a submission number

## Most influential descendants
- K001449: Trident Acetabular Shells: PS (2000), 69 descendants of its own
- K013676: Trident Hemispherical Acetabular Shells (2001), 68 descendants of its own
- 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

## Recalls of this device
- Jul 30, 2026 · Class II · Z-3204-2026: Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which m

## Indications for use
The Osteonics® Secur-Fit™-AD Generation II Acetabular Components are single-use devices. The shells are intended for cemented or cementless fixation within the prepared acetabulum. The Osteonics® Secur-Fit™-AD Generation II Acetabular Component System is compatible with any appropriately selected Osteonics hip stem/femoral head combination. 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 failed 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/K983502
Methodology: https://510kreport.com/methodology