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StarFuse Interphalangeal Pin

by Phalanx Innovations

510(k) K160194

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK160194 Date26 Apr 2016ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HTY
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The StarFuse Interphalangeal Pin is an intramedullary bone fixation fastener used for lesser toe digit correction. It is indicated for use with osteotomies, arthrodeses, and reconstruction procedures involving the correction of the lesser digits of the toes.

The device is available in various diameters (3-4 mm) and lengths (16-30 mm), with straight or pre-bent configurations. It is a bioabsorbable intramedullary arthrodesis implant intended for adaptation-capable or exercise-capable fixation of small bone reconstruction limited to interphalangeal fusion of the toes. The device has FDA 510(k) clearance with number K160194.

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