Cleared Traditional

K881954 - CONCEPT POWER SYSTEM

K881954 is an FDA 510(k) clearance for CONCEPT POWER SYSTEM, manufactured by Concept, Inc.. The device is a Class 1 Orthopedic device with product code HSZ cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K881954 · Concept, Inc. · Orthopedic device
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Nov 1988
Decision
183d
Days
Class 1
Risk

K881954 is an FDA 510(k) clearance for the CONCEPT POWER SYSTEM. Classified as Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment (product code HSZ), Class I - General Controls.

Submitted by Concept, Inc. (Clearwater, US). The FDA issued a Cleared decision on November 9, 1988 after a review of 183 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 Concept, Inc. devices

FDA 510(k) Submission Details - K881954

510(k) Number K881954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1988
Decision Date November 09, 1988
Days to Decision 183 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
61d slower than avg
Panel avg: 122d · This submission: 183d
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 K881954.
THE KIRSCHNER UNIVERSAL POWER TOOL SYSTEM
K901455 · Kirschner Medical Corp. · May 1990
BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500
K900210 · Micro-Aire Surgical Instruments, Inc. · Feb 1990
INTERMEDICS POWER BROACH IMPACTOR
K895121 · Intermedics Orthopedics · Sep 1989
ARTUS DISPOSABLE SHEATHS/CUTTERS
K880881 · Acufex Microsurgical, Inc. · May 1988
ACE PNEUMATIC OSCILLATING SAW
K881250 · Buckman Co., Inc. · Apr 1988
MICRO-AIRE CEMENT REMOVAL TOOLS
K880324 · Micro-Aire Surgical Instruments, Inc. · Feb 1988