Cleared Special

K020761 - POWER TEK II

K020761 is the FDA 510(k) clearance for POWER TEK II by Biomet, Inc.. It is a Class 2 Orthopedic device (product code HRX) cleared through the Special 510(k) pathway after a 27-day FDA review.

K020761 · Biomet, Inc. · Orthopedic device
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Apr 2002
Decision
27d
Days
Class 2
Risk

K020761 is an FDA 510(k) clearance for the POWER TEK II. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on April 3, 2002 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Biomet, Inc. devices

Submission Details

510(k) Number K020761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2002
Decision Date April 03, 2002
Days to Decision 27 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition 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 At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HRX Arthroscope

All 388
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K020761.
ENDIUS ATAVI SYSTEM
K022199 · Endius, Inc. · Oct 2002
ENDIUS FLEXTIP BLADE
K022578 · Endius, Inc. · Aug 2002
ENDIUS ATAVI SYSTEM
K021748 · Endius, Inc. · Jun 2002
RESECTION ABLATOR
K013117 · Linvatec Corp. · Nov 2001
REPROCESSED DYONICS ARTHROSCOPIC BURS
K012652 · Alliance Medical Corp. · Nov 2001
REPROCESSED ATHROSCOPICS BURS
K012605 · Alliance Medical Corp. · Nov 2001