# K952471: Biofix Bioabsorabable Self-Reinforced Poly-L-Lactide, Threaded Fixation Rod

- Pathway: 510(k) (Traditional)
- Applicant: Bioscience, Inc.
- Decided: Aug 7, 1995 after 73 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
501 later devices descend from it; 6 cite it directly.
0 of 502 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
- K992947: Cannulated Smartscrew Models 224540C, 224570C (1999), 413 descendants of its own
- K012001: Smartscrew (2001), 337 descendants of its own
- K030900: Inion Otps Biodegradable Fixaton System (2003), 333 descendants of its own
- K043248: Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS (2005), 306 descendants of its own
- K052776: Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257, AR-TBD (2005), 217 descendants of its own

Source page: https://510kreport.com/device/K952471
Methodology: https://510kreport.com/methodology