510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K905298Substantially Equivalent

Titan Total Hip Device

Dr. Jean-Marc Guichet, New York City NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905298 is the FDA 510(k) clearance record for TITAN TOTAL HIP DEVICE, a class II device, cleared for Dr. Jean-Marc Guichet on under FDA product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented). FDA records list one 510(k) clearance for Dr. Jean-Marc Guichet. As of , FDA records show no recalls naming K905298.

Clearance record

Decision date
Received
(202 days to decision)
Product code
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Regulation
21 CFR 888.3350
Device class
Class II
Review panel
Orthopedic
Applicant
Dr. Jean-Marc Guichet 500 Riverside Dr., #2n, New York City NY
Third party review
No

Clearances, product code JDI

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