# K873251: Omnifit Bone Screw

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Sep 18, 1987 after 32 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 29 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K173380: b-ONE® Total Hip System (2018), 0 descendants of its own

## Recalls of this device
- Jun 26, 2009 · Not classified · Z-2176-2009: Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
- Jun 26, 2009 · Not classified · Z-2137-2009: Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
- Jun 26, 2009 · Not classified · Z-2123-2009: Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
- Jun 26, 2009 · Not classified · Z-2126-2009: Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
- Jun 26, 2009 · Not classified · Z-2124-2009: Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
- Jun 26, 2009 · Not classified · Z-2117-2009: Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
- Jun 26, 2009 · Not classified · Z-2119-2009: Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
- Jun 26, 2009 · Not classified · Z-2120-2009: Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
- Jun 26, 2009 · Not classified · Z-2140-2009: Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
- Jun 26, 2009 · Not classified · Z-2142-2009: Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
- Jun 26, 2009 · Not classified · Z-2130-2009: Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
- Jun 26, 2009 · Not classified · Z-2134-2009: Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
- Jun 26, 2009 · Not classified · Z-2125-2009: Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
- Jun 26, 2009 · Not classified · Z-2136-2009: Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
- Jun 26, 2009 · Not classified · Z-2121-2009: Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
- Jun 26, 2009 · Not classified · Z-2135-2009: Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
- Jun 26, 2009 · Not classified · Z-2143-2009: Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
- Jun 26, 2009 · Not classified · Z-2139-2009: Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
- Jun 26, 2009 · Not classified · Z-2138-2009: Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
- Jun 26, 2009 · Not classified · Z-2127-2009: Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
- Jun 26, 2009 · Not classified · Z-2129-2009: Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
- Jun 26, 2009 · Not classified · Z-2122-2009: Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
- Jun 26, 2009 · Not classified · Z-2141-2009: Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
- Jun 26, 2009 · Not classified · Z-2128-2009: Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
- Jun 26, 2009 · Not classified · Z-2133-2009: Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
- Jun 26, 2009 · Not classified · Z-2132-2009: Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
- Jun 26, 2009 · Not classified · Z-2131-2009: Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
- Jun 26, 2009 · Not classified · Z-2118-2009: Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
- Dec 20, 2005 · Not classified · Z-2007-2008: The firm has been made aware that one lot of 6.5 Cancellous Bone Screws 25mm was packaged and labeled as 25 mm in length when it maybe 20 mm in length.

Source page: https://510kreport.com/device/K873251
Methodology: https://510kreport.com/methodology