Cleared Traditional

K971544 - SYNTHES (USA) COMPACT AIR DRIVE II (CAD II)

K971544 is an FDA 510(k) clearance for SYNTHES (USA) COMPACT AIR DRIVE II (CAD II), manufactured by Synthes (Usa). The device is a Class 1 Orthopedic device with product code HWE cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K971544 · Synthes (Usa) · Orthopedic device
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May 1997
Decision
30d
Days
Class 1
Risk

K971544 is an FDA 510(k) clearance for the SYNTHES (USA) COMPACT AIR DRIVE II (CAD II). Classified as Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (product code HWE), Class I - General Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on May 28, 1997 after a review of 30 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 Synthes (Usa) devices

FDA 510(k) Submission Details - K971544

510(k) Number K971544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1997
Decision Date May 28, 1997
Days to Decision 30 days
Submission Type Traditional
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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

HWE Device Classification - Class 1, General Controls

Product Code HWE Instrument, Surgical, Orthopedic, Ac-powered Motor And 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 - HWE Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment

All 52
Devices cleared under the same product code (HWE) and FDA review panel - the closest regulatory comparables to K971544.
BONE GRAFT HARVESTER
K973560 · Ds Mfg., Inc. · Nov 1997
SURGICAL BURS AND SURGICAL DRILL BITS
K972508 · Synvasive Technology, Inc. · Aug 1997
DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD)
K971342 · Disk Whisk, Inc. · Jul 1997
SERVOTRONIC EC100 SYSTEM
K962087 · Medicon, Inc. · Apr 1997
RIWO DRIVE WITH FOOTSWITCH/MOTOR HANDLE, COOMPLETE,6000RPM/3000RPM/ROTARY BLADES AND ABRADERS SEE SECTION 1:
K970088 · Richard Wolf Medical Instruments Corp. · Apr 1997
MEDNEXT SURGICAL BUR
K970023 · Mednext, Inc. · Feb 1997