# K941941: Bone Mulch Screw

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Feb 2, 1995 after 287 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 3 cite it directly.
0 of 8 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
- K993025: Modification to Bone Mulch Screw System (1999), 6 descendants of its own
- K042552: Bio-Core Interference Screw (2004), 4 descendants of its own
- K140879: Biosure Healicoil PK Interference Screw (2014), 1 descendant of its own
- K071464: Inion Hexalon Biodegradable Acl/PCL Screw (2007), 1 descendant of its own
- K142948: BIOSURE REGENESORB interference Screw (2015), 0 descendants of its own

## Recalls of this device
- Dec 22, 2009 · Not classified · Z-0779-2010: The screw may not have the hex dimension inside of the head of the screw, which will prevent the device from being implantable. This may cause a delay in the procedure while another screw is obtained.

Source page: https://510kreport.com/device/K941941
Methodology: https://510kreport.com/methodology