Cleared Traditional

K934059 - DALL MILES SYSTEM GROOVED BUTTON

K934059 is an FDA 510(k) clearance for DALL MILES SYSTEM GROOVED BUTTON, 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 347-day FDA review.

K934059 · Howmedica Corp. · Orthopedic device
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Aug 1994
Decision
347d
Days
Class 2
Risk

K934059 is an FDA 510(k) clearance for the DALL MILES SYSTEM GROOVED BUTTON. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on August 1, 1994 after a review of 347 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 Howmedica Corp. devices

FDA 510(k) Submission Details - K934059

510(k) Number K934059 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 19, 1993
Decision Date August 01, 1994
Days to Decision 347 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
225d slower than avg
Panel avg: 122d · This submission: 347d
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 K934059.
CABLE-EASE PLATE AND CABLE SYSTEM
K944529 · Intermedics Orthopedics · Feb 1995
CCG CERCLAGE SYSTEM
K932024 · Encore Orthopedics, Inc. · Feb 1995
PIONEER LABORATORIES BONE PLATE WITH CERCLAGE CABLES
K940729 · Pioneer Surgical Technology · Dec 1994
SONGER CABLE SYSTEM
K941213 · Pioneer Surgical Technology · Apr 1994
FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEM
K935646 · Biodynamic Technologies, Inc. · Mar 1994
FX-CABLELOK CABLE/PLATE SYSTEM
K935950 · Buckman Co., Inc. · Mar 1994