# K993025: Modification to Bone Mulch Screw System

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Oct 8, 1999 after 29 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K941941 (1995). 2 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941941: Bone Mulch Screw, Biomet, Inc. (1995) Summary page 1.
- K991298: Bone Mulch Screw System, Biomet, Inc. (1999) Summary page 1.

## Most influential descendants
- 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
- K130716: Bioretec Activascrew Interference (2013), 0 descendants of its own

## Indications for use
The Bone Mulch Screw System is indicated for use in anterior cruciate ligament (ACL) reconstruction using semigracilis/semitendinosus or fasc ... lata (namstring tendons) graft. It is intended for use in fixing the graft within the femoral graft tunnel.

Source page: https://510kreport.com/device/K993025
Methodology: https://510kreport.com/methodology