Cleared Traditional

K945294 - DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE

K945294 is an FDA 510(k) clearance for DALL MILES SYSTEM HOMOGENEOUS VITALLIUM..., 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 127-day FDA review.

K945294 · Howmedica Corp. · Orthopedic device
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Mar 1995
Decision
127d
Days
Class 2
Risk

K945294 is an FDA 510(k) clearance for the DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on March 7, 1995 after a review of 127 days - within the typical 510(k) review window.

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 - K945294

510(k) Number K945294 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 31, 1994
Decision Date March 07, 1995
Days to Decision 127 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
5d slower than avg
Panel avg: 122d · This submission: 127d
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 K945294.
CERCLAGE WIRE CRIMP BLOCK
K960651 · Acu Med, Inc. · May 1996
SYNTHES WIRE MOUNT
K953777 · Synthes (Usa) · Mar 1996
DALL-MILES SUTURE/BEADED CABLE
K953818 · Howmedica Corp. · Oct 1995
CABLE-EASE PLATE AND CABLE SYSTEM - TROCHANTERIC HOOK
K950027 · Intermedics Orthopedics · Mar 1995
CABLE-EASE PLATE AND CABLE SYSTEM
K944529 · Intermedics Orthopedics · Feb 1995
CCG CERCLAGE SYSTEM
K932024 · Encore Orthopedics, Inc. · Feb 1995