Cleared Traditional

K031083 - OPUS MAGNUM IMPLANT SYSTEM

K031083 is an FDA 510(k) clearance for OPUS MAGNUM IMPLANT SYSTEM, manufactured by Opus Medical, Inc.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K031083 · Opus Medical, Inc. · Orthopedic device
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Jun 2003
Decision
69d
Days
Class 2
Risk

K031083 is an FDA 510(k) clearance for the OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Opus Medical, Inc. (San Juan Capistrano, US). The FDA issued a Cleared decision on June 12, 2003 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Opus Medical, Inc. devices

FDA 510(k) Submission Details - K031083

510(k) Number K031083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2003
Decision Date June 12, 2003
Days to Decision 69 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
53d faster than avg
Panel avg: 122d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HTY Pin, Fixation, Smooth

All 103
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K031083.
HUMERAL STAPLE
K041355 · Smith & Nephew, Inc. · Jul 2004
HANSSON PIN SYSTEM
K033968 · Howmedica Osteonics Corp. · Feb 2004
ACE NANCY NAIL
K032687 · DePuy Orthopaedics, Inc. · Oct 2003
K-FIX
K022597 · New Deal, S.A. · Nov 2002
NEWDEAL K WIRE
K022599 · New Deal, S.A. · Oct 2002
2MM PEDIATRIC FLEX NAIL
K022531 · Biomet, Inc. · Aug 2002