Cleared Traditional

K811005 - CORB TM COUNTERROTATING BIOPSY NEEDLE

K811005 is an FDA 510(k) clearance for CORB TM COUNTERROTATING BIOPSY NEEDLE, manufactured by Zimmer, Inc.. The device is a Class 1 Orthopedic device with product code HSZ cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K811005 · Zimmer, Inc. · Orthopedic device
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Jun 1981
Decision
62d
Days
Class 1
Risk

K811005 is an FDA 510(k) clearance for the CORB TM COUNTERROTATING BIOPSY NEEDLE. Classified as Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (product code HSZ), Class I - General Controls.

Submitted by Zimmer, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 15, 1981 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4820 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Zimmer, Inc. devices

FDA 510(k) Submission Details - K811005

510(k) Number K811005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1981
Decision Date June 15, 1981
Days to Decision 62 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 122d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

HSZ Device Classification - Class 1, General Controls

Product Code HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment

All 31
Devices cleared under the same product code (HSZ) and FDA review panel - the closest regulatory comparables to K811005.
ENDOTOME PNEUMATIC ORTHOPAEDIC CUT
K840831 · Cabot Medical Corp. · Apr 1984
ANSPACH 65,000
K831756 · The Anspach Effort, Inc. · Sep 1983
MICRO OSCILLATING SAW
K811834 · Micro-Aire Surgical Instruments, Inc. · Jul 1981
OSTEO OSCILAIR
K803284 · Richard'S Medical Equip., Inc. · Jan 1981
ANSPACH INSTRUMENT CADDY
K801329 · The Anspach Effort, Inc. · Jun 1980
CEBOTOME DRILL
K800275 · American Sterilizer Co. · Feb 1980