Cleared Traditional

K010658 - MODIFIED USS FRACTURE SYSTEM

K010658 is an FDA 510(k) clearance for MODIFIED USS FRACTURE SYSTEM, manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K010658 · Synthes (Usa) · Orthopedic device
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Jun 2001
Decision
90d
Days
Class 2
Risk

K010658 is an FDA 510(k) clearance for the MODIFIED USS FRACTURE SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on June 4, 2001 after a review of 90 days - within the typical 510(k) review window.

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: 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 Synthes (Usa) devices

FDA 510(k) Submission Details - K010658

510(k) Number K010658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2001
Decision Date June 04, 2001
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 244
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K010658.
TRI-FIX SPINAL FIXATION SYSTEM
K010922 · Endius, Inc. · Jun 2001
SYNERGY 4.0 MM, 4.5 MM VLS SCREWS
K011437 · Interpore Cross Intl. · Jun 2001
MODIFICATION TO TSRH SPINAL SYSTEM
K011029 · Medtronic Sofamor Danek, Inc. · Jun 2001
END-TO-END AND SIDE-BY-SIDE CONNECTORS
K010563 · Spinal Concepts, Inc. · May 2001
MONARCH SPINE SYSTEM
K010576 · Depuyacromed · May 2001
BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR
K003735 · Blackstone Medical, Inc. · May 2001