Cleared Traditional

K001254 - ORTHOMATRIX, INC. CERCLAGE SYSTEM

K001254 is an FDA 510(k) clearance for ORTHOMATRIX, manufactured by Orthomatrix, Inc.. The device is a Class 2 Orthopedic device with product code JDQ cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K001254 · Orthomatrix, Inc. · Orthopedic device
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Dec 2000
Decision
238d
Days
Class 2
Risk

K001254 is an FDA 510(k) clearance for the ORTHOMATRIX, INC. CERCLAGE SYSTEM. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Orthomatrix, Inc. (Collierville, US). The FDA issued a Cleared decision on December 13, 2000 after a review of 238 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 Orthomatrix, Inc. devices

FDA 510(k) Submission Details - K001254

510(k) Number K001254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2000
Decision Date December 13, 2000
Days to Decision 238 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 122d · This submission: 238d
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 103
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K001254.
SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM
K031508 · Synthes (Usa) · May 2003
SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM
K031162 · Smith & Nephew, Inc. · May 2003
SYNTHES STERNAL FIXATION SYSTEM
K010943 · Synthes (Usa) · Jun 2001
SPL CRIMP SYSTEM
K002110 · Pioneer Surgical Technology · Oct 2000
TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 501-066, 501-067
K001709 · Pioneer Surgical Technology · Aug 2000
WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013
K993903 · Whiteside Biomechanics, Inc. · Feb 2000