# K010983: Plla Pin

- Pathway: 510(k) (Special)
- Applicant: Bionx Implants, Inc.
- Decided: Jun 13, 2001 after 72 days
- Product code: HTY (Pin, Fixation, Smooth)
- 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
No predicates in its family tree.
385 later devices descend from it; 4 cite it directly.
0 of 386 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
- K031712: Inion Otps Biodegradable Pin (2003), 382 descendants of its own
- K033717: Transet Fracture Fixation System (2004), 309 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
- K083070: Toggleloc System (2008), 94 descendants of its own

Source page: https://510kreport.com/device/K010983
Methodology: https://510kreport.com/methodology