510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K931131Substantially Equivalent for Some Indications

The Richards Wrist

Smith & Nephew Richards, Inc., Memphis TN / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K931131 is the FDA 510(k) clearance record for THE RICHARDS WRIST, a class II device, cleared for Smith & Nephew Richards, Inc. on under FDA product code JWJ (Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained). FDA records list 87 510(k) clearances for Smith & Nephew Richards, Inc., from to . As of , FDA records show no recalls naming K931131.

Clearance record

Decision date
Received
(532 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
Smith & Nephew Richards, Inc. 1450 Brooks Rd., Memphis TN
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