510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061465Unknown

Kmi Cement Restrictor Implant

Kinetikos Medical, Inc., Carlsbad CA / Traditional, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061465 is the FDA 510(k) clearance record for KMI CEMENT RESTRICTOR IMPLANT, a class II device, cleared for Kinetikos Medical, Inc. on under FDA product code JDK (Prosthesis, Hip, Cement Restrictor). FDA records list 19 510(k) clearances for Kinetikos Medical, Inc., from to . As of , FDA records show no recalls naming K061465.

Clearance record

Decision date
Received
(132 days to decision)
Product code
JDK Prosthesis, Hip, Cement Restrictor
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Kinetikos Medical, Inc. 6005 Hidden Valley Rd., Suite 180, Carlsbad CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JDK

Trailing 12 months

FDA records hold no clearances under product code JDK in the trailing twelve months.

FDA records show no clearances under product code JDK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JDK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260