# K800207: Uhr UNIVERSAL6HIP Replacement

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Feb 11, 1980 after 12 days
- Product code: KWL (Prosthesis, Hip, Hemi-, Femoral, Metal)
- Device class: 2
- Regulation: 21 CFR 888.3360
- Recalls of this device: 36 (0 Class I)
- 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; 6 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
- K112019: Bencox ID Stem, Bencox Metal Head, Bencox Bipolar Cup (2011), 10 descendants of its own
- K121665: Bencox Foret & Bencox Delta (2012), 8 descendants of its own
- K150007: Modified Bencox Hip System (2015), 7 descendants of its own
- K162127: Bencox M Stem Lateralized & Bencox Mirabo Cup System (2016), 6 descendants of its own
- K222632: UHR Bipolar Implants, Restoration GAP II Implants (2022), 5 descendants of its own

## Recalls of this device
- Oct 26, 2007 · Not classified · Z-0621-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0626-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0642-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0643-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0644-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0622-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0627-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0628-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0629-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0636-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0639-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0623-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0624-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0631-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0632-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0635-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0645-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0647-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0651-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0652-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0653-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0654-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0655-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0625-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0630-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0633-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0634-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0637-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0638-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0640-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0641-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0646-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0648-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0649-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0650-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.
- Oct 26, 2007 · Not classified · Z-0656-2008: Incorrect part: Device may have an incorrect locking ring assembled with the UHR bipolar head.

Source page: https://510kreport.com/device/K800207
Methodology: https://510kreport.com/methodology