Cleared Traditional

K921480 - OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM

K921480 is an FDA 510(k) clearance for OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM, manufactured by Acu Med, Inc.. The device is a Class 2 Orthopedic device with product code JDQ cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K921480 · Acu Med, Inc. · Orthopedic device
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Jun 1992
Decision
88d
Days
Class 2
Risk

K921480 is an FDA 510(k) clearance for the OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Acu Med, Inc. (Beaveton, US). The FDA issued a Cleared decision on June 26, 1992 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3010 - 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 Acu Med, Inc. devices

FDA 510(k) Submission Details - K921480

510(k) Number K921480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1992
Decision Date June 26, 1992
Days to Decision 88 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDQ Device Classification - Class 2, Special Controls

Product Code JDQ Cerclage, Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3010
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - JDQ Cerclage, Fixation

All 108
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K921480.
CODMAN SOFWIRE(TM) KIT
K926116 · Codman & Shurtleff, Inc. · Mar 1993
TITANIUM SONGER CABLE SYSTEM
K925812 · Sofamor Danek Mfg., Inc. · Mar 1993
SONGER CABLE SYSTEM
K922952 · Pioneer Surgical Technology · Feb 1993
TITANIUM ALLOY SONGER CABLE SYSTEM
K920201 · Sofamor Danek Mfg., Inc. · Apr 1992
FX-CABLELOK SYSTEM, MODIFICATION
K915259 · Biodynamic Technologies, Inc. · Feb 1992
CODMAN SOF'WIRE (TM) KIT
K915581 · Codman & Shurtleff, Inc. · Jan 1992