510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K020554Substantially Equivalent

Modification to Universal Total Wrist System

Kinetikos Medical, Inc., San Diego CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020554 is the FDA 510(k) clearance record for MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM, a class II device, cleared for Kinetikos Medical, Inc. on under FDA product code JWJ (Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained). FDA records list 19 510(k) clearances for Kinetikos Medical, Inc., from to . As of , FDA records show no recalls naming K020554.

Clearance record

Decision date
Received
(72 days to decision)
Product code
JWJ Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
Regulation
21 CFR 888.3800
Device class
Class II
Review panel
Orthopedic
Applicant
Kinetikos Medical, Inc. 4329 Graydon Rd., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JWJ

Trailing 12 months

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

FDA records show no clearances under product code JWJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JWJ, 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