510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K111635Substantially Equivalent

Smith & Nephew Rj Constrained Liners

Smith & Nephew, Inc., Memphis TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111635 is the FDA 510(k) clearance record for SMITH & NEPHEW RJ CONSTRAINED LINERS, a class II device, cleared for Smith & Nephew, Inc. on under FDA product code KWZ (Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer). FDA records list 572 510(k) clearances for Smith & Nephew, Inc., from to . As of , FDA records show no recalls naming K111635.

Clearance record

Decision date
Received
(88 days to decision)
Product code
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Regulation
21 CFR 888.3310
Device class
Class II
Review panel
Orthopedic
Applicant
Smith & Nephew, Inc. 1450 Brooks Rd., Memphis TN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KWZ

Trailing 12 months

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

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