# K980774: Osteonics Gap-II Restoration Acetabular Shells

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Apr 29, 1998 after 58 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 3 cite it directly.
0 of 12 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® Restoration Acetabular Cup Series: named in the summary without a submission number
- (no number) Osteonics® Omnifit® Cup Inserts: named in the summary without a submission number
- (no number) Osteonics® Concentric Polyethylene Acetabular Cup: named in the summary without a submission number
- (no number) Osteonics® Flanged Polyethylene Acetabular Cup: named in the summary without a submission number

## Most influential descendants
- K222632: UHR Bipolar Implants, Restoration GAP II Implants (2022), 5 descendants of its own
- K233498: Stryker Orthopaedics Hip Systems Labeling Update (2023), 4 descendants of its own
- K163441: Locking Cage, Full XPE Cup (2017), 3 descendants of its own
- K243784: Stryker Orthopaedics Hip Devices Labeling Update (2025), 2 descendants of its own
- K172833: E-XPE Acetabular Components and U-Motion II Acetabular Cup (2018), 2 descendants of its own

## Indications for use
The indications for the use of the Osteonics® GAP-II Restoration Acetabular Shells, in keeping with those of other legally marketed Osteonics acetabular components, are as follows: 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 arthreplasty- or-other -- procedure. Clinical management problems where arthrodesxs or alternative reconstructive techniques are less likely to achieve satisfactory results:- A Where bone stock is of poor quality or is madequate for other reconstructive techniques as indicated by deficiencies of the acetabulum. Class III cavitary and segmental defects.

Source page: https://510kreport.com/device/K980774
Methodology: https://510kreport.com/methodology