Cleared Traditional

K840831 - ENDOTOME PNEUMATIC ORTHOPAEDIC CUT

K840831 is an FDA 510(k) clearance for ENDOTOME PNEUMATIC ORTHOPAEDIC CUT, manufactured by Cabot Medical Corp.. The device is a Class 1 Orthopedic device with product code HSZ cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K840831 · Cabot Medical Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1984
Decision
40d
Days
Class 1
Risk

K840831 is an FDA 510(k) clearance for the ENDOTOME PNEUMATIC ORTHOPAEDIC CUT. Classified as Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (product code HSZ), Class I - General Controls.

Submitted by Cabot Medical Corp. (Walker, US). The FDA issued a Cleared decision on April 4, 1984 after a review of 40 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 Cabot Medical Corp. devices

FDA 510(k) Submission Details - K840831

510(k) Number K840831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1984
Decision Date April 04, 1984
Days to Decision 40 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 122d · This submission: 40d
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 K840831.
REPLACEMENT HOSES
K861405 · Micro-Aire Surgical Instruments, Inc. · Apr 1986
MICRO-AIRE OSCILLATING SAW, 1740-000 & WIRE DRIVER
K851443 · Micro-Aire Surgical Instruments, Inc. · May 1985
ACUFEX ARTHROSCOPIC SHAVER
K844130 · Acufex Microsurgical, Inc. · Mar 1985
ANSPACH 65,000
K831756 · The Anspach Effort, Inc. · Sep 1983
MICRO OSCILLATING SAW
K811834 · Micro-Aire Surgical Instruments, Inc. · Jul 1981
CORB TM COUNTERROTATING BIOPSY NEEDLE
K811005 · Zimmer, Inc. · Jun 1981