Cleared Traditional

ORTHOMATRIX, INC. CERCLAGE SYSTEM (K001254) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 53
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
SYNTHES CERCLAGE POSITIONING PIN
K992891 · Synthes (Usa) · Nov 1999
DALL-MILES CABLE GRIP (A-GRIP)
K984432 · Howmedica Osteonics Corp. · Feb 1999
BMP CABLE SYSTEM
K982545 · Biomet, Inc. · Oct 1998