Cleared Traditional

K953818 - DALL-MILES SUTURE/BEADED CABLE

K953818 is the FDA 510(k) clearance for DALL-MILES SUTURE/BEADED CABLE by Howmedica Corp.. It is a Class 2 Orthopedic device (product code JDQ) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K953818 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
58d
Days
Class 2
Risk

K953818 is an FDA 510(k) clearance for the DALL-MILES SUTURE/BEADED 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 October 12, 1995 after a review of 58 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Howmedica Corp. devices

Submission Details

510(k) Number K953818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1995
Decision Date October 12, 1995
Days to Decision 58 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 122d · This submission: 58d
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 K953818.
DALL-MILES HOMOGENOUS VITALLIUM CABLE
K961283 · Howmedica Corp. · May 1996
CERCLAGE WIRE CRIMP BLOCK
K960651 · Acu Med, Inc. · May 1996
SYNTHES WIRE MOUNT
K953777 · Synthes (Usa) · Mar 1996
DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE
K945294 · Howmedica Corp. · Mar 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