# K000817: Omega II Modular Total Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Osteoimplant Technology, Inc.
- Decided: Jun 8, 2000 after 87 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- May 8, 2008 · Not classified · Z-1868-2008: Product not manufactured to specifications; modular femoral necks found to contain 24 scallops, instead of the standard 12.
- Apr 12, 2007 · Not classified · Z-1064-2007: Sterility/Package Integrity : Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions.
- Apr 12, 2007 · Not classified · Z-1065-2007: Sterility/Package Integrity: Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions.
- Apr 12, 2007 · Not classified · Z-1066-2007: Sterility/Package Integrity: Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions.
- Apr 12, 2007 · Not classified · Z-1063-2007: Sterility/Package Integrity : Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions.

Source page: https://510kreport.com/device/K000817
Methodology: https://510kreport.com/methodology