# K983382: Osteonics HA Generation II Acetabular Component System

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Dec 11, 1998 after 77 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: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
153 later devices descend from it; 10 cite it directly.
0 of 154 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™-HA Acetabular Components (previously known as the Osteonics® Secur-Fit™ AD-HA Acetabular Component System): 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® Secur-Fit™ HA X’tra Acetabular Component System: named in the summary without a submission number
- (no number) Osteonics® Threaded HA Acetabular Shells: 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
- K001448: Trident Acetabular Shells: PS-HA (2000), 150 descendants of its own
- K060437: Excia Total Hip System with U-Cap (2006), 90 descendants of its own
- K080584: Metha Short Stem Hip System (2008), 83 descendants of its own
- K071916: Metha Hip System (2008), 68 descendants of its own
- K013676: Trident Hemispherical Acetabular Shells (2001), 68 descendants of its own

## Recalls of this device
- Dec 15, 2014 · Class II · Z-1043-2015: Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-11-50E lot 49073501) alleging that when the packages were opened there were no dome holes plugs present
- Aug 30, 2007 · Not classified · Z-0073-2008: Stryker Orthopaedics had identified that specific lots of Trident PSL Acetabular shells may have a dimensional discrepancy. The deviation regarding the difference in wall thickness will increase the g
- Aug 30, 2007 · Not classified · Z-0072-2008: Stryker Orthopaedics had identified that specific lots of Trident PSL Acetabular shells may have a dimensional discrepancy. The deviation regarding the difference in wall thickness will increase the g
- Mar 13, 2006 · Not classified · Z-1261-2007: Dimensional anomaly

## Indications for use
The Osteonics® HA Generation II Acetabular Components are single-use devices. The shells are intended for cementless fixation within the prepared acetabulum. The Osteonics® HA 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/K983382
Methodology: https://510kreport.com/methodology