Cleared Traditional

K931246 - CERCLAGE WIRE CRIMP SLEEVE (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K931246 · Acu Med, Inc. · Orthopedic device
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Feb 1994
Decision
348d
Days
Class 2
Risk

K931246 is an FDA 510(k) clearance for the CERCLAGE WIRE CRIMP SLEEVE. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Acu Med, Inc. (Beaverton, US). The FDA issued a Cleared decision on February 22, 1994 after a review of 348 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Acu Med, Inc. devices

Submission Details

510(k) Number K931246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1993
Decision Date February 22, 1994
Days to Decision 348 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
226d slower than avg
Panel avg: 122d · This submission: 348d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 128
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K931246.
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VariTrax Sternal CircumFixation System
K232986 · Circumfix Solutions, Inc. · Jan 2024
Arthrex Radiopaque FiberTape Cerclage sutures
K230976 · Arthrex, Inc. · Aug 2023