Cleared Traditional

K833940 - TORQUE PLUS CATALOG 30120

K833940 is an FDA 510(k) clearance for TORQUE PLUS CATALOG 30120, manufactured by Concept, Inc.. The device is a Class 1 Orthopedic device with product code HWE cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K833940 · Concept, Inc. · Orthopedic device
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Dec 1983
Decision
43d
Days
Class 1
Risk

K833940 is an FDA 510(k) clearance for the TORQUE PLUS CATALOG 30120. Classified as Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (product code HWE), Class I - General Controls.

Submitted by Concept, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 28, 1983 after a review of 43 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 Concept, Inc. devices

FDA 510(k) Submission Details - K833940

510(k) Number K833940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1983
Decision Date December 28, 1983
Days to Decision 43 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
79d faster than avg
Panel avg: 122d · This submission: 43d
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 33
Devices cleared under the same product code (HWE) and FDA review panel - the closest regulatory comparables to K833940.
3M ARTHROSCOPIC SURGICAL SYSTEM
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K853489 · Chattanooga Group, Inc. · Sep 1985
C-BLADE
K802105 · Cutter Laboratories, Inc. · Sep 1980
INTRA-ARTICULATED EDGER-PLANER SYSTEM
K792353 · Richard Wolf Medical Instruments Corp. · Dec 1979
CHARNLEY FEMUR DRILL #1 AND #2
K760977 · Codman & Shurtleff, Inc. · Nov 1976