# K091955: Stryker Sonicpin System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Apr 2, 2010 after 275 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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) INION OTPS Pin: named in the summary without a submission number
- (no number) Synthes POLYPIN 2.0: named in the summary without a submission number
- (no number) Howmedica Bioabsorbable Pin: named in the summary without a submission number
- (no number) KLS-Martin, L.P. RESORB-X SF: named in the summary without a submission number

## Most influential descendants
- K143063: Stryker SonicPin System, Stryker SonicAnchor System (2015), 1 descendant of its own
- K170418: Stryker SonicPin System (2017), 0 descendants of its own

## Indications for use
The Stryker SonicPin System is intended to maintain alignment and fixation of bone fractures, osteotomies, or bone grafts in hallux valgus applications in the presence of appropriate immobilization (e.g. rigid fixation implants, cast, brace). The Stryker SonicPin is designed only to be inserted with the ultrasonic driver of the Stryker SonicPin System.

Source page: https://510kreport.com/device/K091955
Methodology: https://510kreport.com/methodology