510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K823051Substantially Equivalent

Metal Knee & Hip Prosthesis

Zimmer GmbH, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K823051 is the FDA 510(k) clearance record for METAL KNEE & HIP PROSTHESIS, a class II device, cleared for Zimmer, Inc. on under FDA product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal). FDA records list 872 510(k) clearances for Zimmer, Inc., from to . As of , FDA records show no recalls naming K823051.

Clearance record

Decision date
Received
(46 days to decision)
Product code
KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Regulation
21 CFR 888.3360
Device class
Class II
Review panel
Orthopedic
Applicant
Zimmer, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code KWL

Trailing 12 months
3 clearances under product code KWL in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KWL, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20261
August 20260
September 20260
October 20260