Cleared Traditional

K922142 - FX-CABLELOK SYSTEM

K922142 is an FDA 510(k) clearance for FX-CABLELOK SYSTEM, manufactured by Bio-Tech Co.. The device is a Class 2 Orthopedic device with product code JDQ cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K922142 · Bio-Tech Co. · Orthopedic device
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Nov 1992
Decision
198d
Days
Class 2
Risk

K922142 is an FDA 510(k) clearance for the FX-CABLELOK SYSTEM. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Bio-Tech Co. (Arlington, US). The FDA issued a Cleared decision on November 20, 1992 after a review of 198 days - an extended review 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: 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 Bio-Tech Co. devices

FDA 510(k) Submission Details - K922142

510(k) Number K922142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1992
Decision Date November 20, 1992
Days to Decision 198 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 122d · This submission: 198d
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 111
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K922142.
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
OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM
K921480 · Acu Med, Inc. · Jun 1992
TITANIUM ALLOY SONGER CABLE SYSTEM
K920201 · Sofamor Danek Mfg., Inc. · Apr 1992
FX-CABLELOK SYSTEM, MODIFICATION
K915259 · Biodynamic Technologies, Inc. · Feb 1992