510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K781091Substantially Equivalent

Knee Instrumentation, Condylar

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

K781091 is the FDA 510(k) clearance record for KNEE INSTRUMENTATION, CONDYLAR, a class I device, cleared for Biomet, Inc. on under FDA product code HWT (Template). FDA records list 872 510(k) clearances for ZIMMER GMBH, from to . As of , FDA records show no recalls naming K781091.

Clearance record

Decision date
Received
(14 days to decision)
Product code
HWT Template
Regulation
21 CFR 888.4800
Device class
Class I
Review panel
Orthopedic
Applicant
Biomet, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code HWT

Trailing 12 months

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

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