Cleared Traditional

K042584 - OPUS MINIMAGNUM ANCHOR WITH INSERTER

K042584 is an FDA 510(k) clearance for OPUS MINIMAGNUM ANCHOR WITH INSERTER, manufactured by Opus Medical, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K042584 · Opus Medical, Inc. · Orthopedic device
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Dec 2004
Decision
83d
Days
Class 2
Risk

K042584 is an FDA 510(k) clearance for the OPUS MINIMAGNUM ANCHOR WITH INSERTER. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Opus Medical, Inc. (San Juan Capistrano, US). The FDA issued a Cleared decision on December 14, 2004 after a review of 83 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 - K042584

510(k) Number K042584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2004
Decision Date December 14, 2004
Days to Decision 83 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 122d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 834
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K042584.
MULTI-USE COMPRESSION SCREW
K043102 · Wrightmedicaltechnologyinc · Jan 2005
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K042552 · Biomet, Inc. · Dec 2004
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SPIRALOK ANCHOR
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FASTIN RC ANCHOR
K041075 · Depuy Mitek, A Johnson & Johnson Company · Nov 2004