510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K160194Substantially Equivalent

StarFuse Interphalangeal Pin

Phalanx Innovations, Marietta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160194 is the FDA 510(k) clearance record for StarFuse Interphalangeal Pin, a class II device, cleared for Phalanx Innovations on under FDA product code HTY (Pin, Fixation, Smooth). FDA records list 2 510(k) clearances for Phalanx Innovations, from to . As of , FDA records show no recalls naming K160194.

Clearance record

Decision date
Received
(90 days to decision)
Product code
HTY Pin, Fixation, Smooth
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Phalanx Innovations 200 Cobb Pkw N, Bldg. 200, Suite 210, Marietta GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HTY

Trailing 12 months
2 clearances under product code HTY in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HTY, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260