# K943549: Restoration Acetabular Cup

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Dec 19, 1994 after 151 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
25 later devices descend from it; 4 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K153345: Stryker Orthopaedics Hip Systems Labeling Update (2016), 17 descendants of its own
- K161569: Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws (2016), 11 descendants of its own
- K171768: Trident® II Acetabular System (2017), 10 descendants of its own
- K173499: Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads (2018), 8 descendants of its own
- K182468: Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System (2019), 7 descendants of its own

Source page: https://510kreport.com/device/K943549
Methodology: https://510kreport.com/methodology