Cleared Traditional

K934058 - DALL MILES SYSTEM MINICLEAT

K934058 is the FDA 510(k) clearance for DALL MILES SYSTEM MINICLEAT by Howmedica Corp.. It is a Class 2 Orthopedic device (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

Submission Details

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.

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 82
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K934058.
SONGER CABLE SYSTEM
K941213 · Pioneer Surgical Technology · Apr 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