Cleared Traditional

K934059 - DALL MILES SYSTEM GROOVED BUTTON

K934059 is the FDA 510(k) clearance for DALL MILES SYSTEM GROOVED BUTTON by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JDQ) cleared through the Traditional 510(k) pathway after a 347-day FDA review.

K934059 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 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 CABLE/PLATE SYSTEM
K935950 · Buckman Co., Inc. · Mar 1994
CONTROL CABLE SYSTEM
K934557 · Depuy, Inc. · Feb 1994