510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K020761Substantially Equivalent

Power Tek II

Zimmer GmbH, Warsaw IN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K020761 is the FDA 510(k) clearance record for POWER TEK II, a class II device, cleared for Biomet, Inc. on under FDA product code HRX (Arthroscope). FDA's definition for product code HRX reads: "Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available...". FDA records list 872 510(k) clearances for ZIMMER GMBH, from to . As of , FDA records show no recalls naming K020761.

Clearance record

Decision date
Received
(27 days to decision)
Product code
HRX Arthroscope
Regulation
21 CFR 888.1100
Device class
Class II
Review panel
Orthopedic
Applicant
Biomet, Inc. 56 E Bell Dr., Warsaw IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HRX

Trailing 12 months
9 clearances under product code HRX in the twelve months to November 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code HRX, trailing twelve months
MonthClearances
December 20252
January 20260
February 20260
March 20261
April 20261
May 20261
June 20260
July 20260
August 20262
September 20260
October 20262
November 20260