# K003758: Allofit Acetabular System

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Orthopedics, Inc.
- Decided: Mar 7, 2001 after 91 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 4 cite it directly.
0 of 13 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
- K190660: G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E Highly Crosslinked Polyethylene (2019), 4 descendants of its own
- K103352: Versafitcup CC Trio (2011), 4 descendants of its own
- K120531: Versafitcup CC Trio-Additional Liners (2012), 2 descendants of its own
- K122911: Versafitcup CC Trio Extension (2012), 1 descendant of its own
- K261453: G7® Acetabular System (2026), 0 descendants of its own

Source page: https://510kreport.com/device/K003758
Methodology: https://510kreport.com/methodology