# K961608: Synthes (U.S.a.) Polypin

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: May 9, 1997 after 379 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.
577 later devices descend from it; 4 cite it directly.
0 of 578 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Kirschner wires: named in the summary without a submission number
- (no number) small screws: named in the summary without a submission number
- (no number) Johnson & Johnson OrthoSorb® Absorbable Pin: named in the summary without a submission number
- (no number) Biosciences, Inc. BIOFIX® Bioabsorbable Pin: named in the summary without a submission number

## Most influential descendants
- K974876: Bionx Distal Radius Screw (1998), 419 descendants of its own
- K992947: Cannulated Smartscrew Models 224540C, 224570C (1999), 413 descendants of its own
- K031712: Inion Otps Biodegradable Pin (2003), 382 descendants of its own
- K012001: Smartscrew (2001), 337 descendants of its own
- K030900: Inion Otps Biodegradable Fixaton System (2003), 333 descendants of its own

## Indications for use
The Polypin is intended for use in the fixation of small bone fragments in cases of low-load fractures, such as apical fragments, osteochondral fragments and cancellous/non-load-bearing fragments. Specific applications include the following: Apical fragments: radial head patellar rim navicular metacarpal/metatersal * proximal or distal ends) Osteochondral fragments: talus vault temoral condyle Spongy/non-load bearing fragments: talus

Source page: https://510kreport.com/device/K961608
Methodology: https://510kreport.com/methodology