510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K061681Substantially Equivalent

Repicci II Metal Back Inlay Unicompartmental Tibial Bearing Component

Biomet Manufacturing Corp, Warsaw IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061681 is the FDA 510(k) clearance record for REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT, a class II device, cleared for Biomet Manufacturing Corp on under FDA product code HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer). FDA records list 128 510(k) clearances for Biomet Manufacturing Corp, from to . As of , FDA records show no recalls naming K061681.

Clearance record

Decision date
Received
(126 days to decision)
Product code
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Regulation
21 CFR 888.3530
Device class
Class II
Review panel
Orthopedic
Applicant
Biomet Manufacturing Corp P.O. Box 587, Warsaw IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HRY

Trailing 12 months

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

FDA records show no clearances under product code HRY in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HRY, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260