510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K970733Substantially Equivalent

Synthes Titanium Diastal Femoral Nail (Ti Dfn) System

Synthes (USA) Products LLC, Paoli PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970733 is the FDA 510(k) clearance record for SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEM, a class II device, cleared for Synthes (Usa) on under FDA product code HTY (Pin, Fixation, Smooth). FDA records list 479 510(k) clearances for Synthes (USA) Products LLC, from to . As of , FDA records show one recall naming K970733.

Clearance record

Decision date
Received
(33 days to decision)
Product code
HTY Pin, Fixation, Smooth
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Synthes (Usa) 1690 Russell Rd., Paoli PA
510(k) summary
Summary
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