Cleared Traditional

K010576 - MONARCH SPINE SYSTEM

K010576 is an FDA 510(k) clearance for MONARCH SPINE SYSTEM, manufactured by Depuyacromed. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K010576 · Depuyacromed · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
85d
Days
Class 2
Risk

K010576 is an FDA 510(k) clearance for the MONARCH SPINE SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Depuyacromed (Raynham, US). The FDA issued a Cleared decision on May 23, 2001 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Depuyacromed devices

FDA 510(k) Submission Details - K010576

510(k) Number K010576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2001
Decision Date May 23, 2001
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNI Orthosis, Spinal Pedicle Fixation

All 162
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K010576.
MODIFICATION TO TSRH SPINAL SYSTEM
K011029 · Medtronic Sofamor Danek, Inc. · Jun 2001
MODIFIED USS FRACTURE SYSTEM
K010658 · Synthes (Usa) · Jun 2001
END-TO-END AND SIDE-BY-SIDE CONNECTORS
K010563 · Spinal Concepts, Inc. · May 2001
BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR
K003735 · Blackstone Medical, Inc. · May 2001
MODIFICATION TO TSRH SPINAL SYSTEM
K011067 · Medtronic Sofamor Danek, Inc. · May 2001
SMALL STATURE USS
K994121 · Synthes (Usa) · Oct 2000