# K864912: PDS (Polydioxanon) Absorbable Pin

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Professionals, Inc.
- Decided: Jul 9, 1987 after 206 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.
10 later devices descend from it; 2 cite it directly.
0 of 11 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
- K993074: Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525 (1999), 7 descendants of its own
- K012000: 1.5MM Bone Fixation Kit (2001), 5 descendants of its own
- K013546: Modification to: 1.5 Bone Fixation Kit, Models BXS6114, BXS6214 (2001), 4 descendants of its own
- K031981: 2.4 Smartnail, Models 532416, 532425, 532435, 532445 (2003), 3 descendants of its own
- K041288: Modification to Smartpin (2004), 2 descendants of its own

Source page: https://510kreport.com/device/K864912
Methodology: https://510kreport.com/methodology