# K970957: Osteonics Restoration Acetabular Ring

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Jun 3, 1997 after 78 days
- Product code: JDJ (Mesh, Surgical, Acetabular, Hip, Prosthesis)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 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
- K040680: Contour HA Coated Reconstruction Ring (2004), 6 descendants of its own
- K211176: Smith & Nephew Hip Systems (2022), 3 descendants of its own
- K092098: Patient Specific Acetabular Reconstruction Prosthesis (2010), 1 descendant of its own
- K240783: Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems (2024), 0 descendants of its own
- K242375: OR3O Dual Mobility System (2024), 0 descendants of its own

## Indications for use
The indications for the use of the Osteonics® Restoration Acetabular Rings, 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 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. Class II cavitary or protrusio defects.

Source page: https://510kreport.com/device/K970957
Methodology: https://510kreport.com/methodology