Cleared Traditional

K902525 - ACE/WILLIAMS MICROSURGERY SAW SYSTEM

K902525 is an FDA 510(k) clearance for ACE/WILLIAMS MICROSURGERY SAW SYSTEM, manufactured by Buckman Co., Inc.. The device is a Class 1 Orthopedic device with product code HWE cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K902525 · Buckman Co., Inc. · Orthopedic device
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Nov 1990
Decision
174d
Days
Class 1
Risk

K902525 is an FDA 510(k) clearance for the ACE/WILLIAMS MICROSURGERY SAW SYSTEM. Classified as Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (product code HWE), Class I - General Controls.

Submitted by Buckman Co., Inc. (Concord, US). The FDA issued a Cleared decision on November 26, 1990 after a review of 174 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Buckman Co., Inc. devices

FDA 510(k) Submission Details - K902525

510(k) Number K902525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1990
Decision Date November 26, 1990
Days to Decision 174 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
52d slower than avg
Panel avg: 122d · This submission: 174d
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 K902525.
ARTHREX AR-8200 SHAVER SYSTEM
K932699 · Arthrex, Inc. · Jan 1994
ACUFEX STERILE DRILLS
K931837 · Acufex Microsurgical, Inc. · Jan 1994
CKS OSCILLATING SAW BLADE
K921131 · Techmedica, Inc. · Jun 1992
OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305
K903650 · Micro-Aire Surgical Instruments, Inc. · Sep 1990
HALL MODULAR ACETABULAR REAMER SYSTEM
K902332 · Zimmer, Inc. · Jun 1990
HALL VERSIPOWER SURGICAL INSTRUMENT SYSTEM
K895198 · Zimmer, Inc. · Sep 1989