Cleared Traditional

K934058 - DALL MILES SYSTEM MINICLEAT

K934058 is an FDA 510(k) clearance for DALL MILES SYSTEM MINICLEAT, manufactured by Howmedica Corp.. The device is a Class 2 Orthopedic device with product code JDQ cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K934058 · Howmedica Corp. · Orthopedic device
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Feb 1994
Decision
188d
Days
Class 2
Risk

K934058 is an FDA 510(k) clearance for the DALL MILES SYSTEM MINICLEAT. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on February 23, 1994 after a review of 188 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 Howmedica Corp. devices

FDA 510(k) Submission Details - K934058

510(k) Number K934058 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 19, 1993
Decision Date February 23, 1994
Days to Decision 188 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
66d slower than avg
Panel avg: 122d · This submission: 188d
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 K934058.
FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEM
K935646 · Biodynamic Technologies, Inc. · Mar 1994
FX-CABLELOK CABLE/PLATE SYSTEM
K935950 · Buckman Co., Inc. · Mar 1994
CONTROL CABLE SYSTEM
K934557 · Depuy, Inc. · Feb 1994
CERCLAGE WIRE CRIMP SLEEVE
K931246 · Acu Med, Inc. · Feb 1994
SPONGER CABLE SYSTEM, MODIFICATION
K935481 · Pioneer Surgical Technology · Jan 1994
ORTHOPAEDIC POLYETHYLENE CABLE
K924141 · Smith & Nephew Richards, Inc. · Nov 1993