Cleared Traditional

K013222 - SUMMIT OCCIPITO-CERVICO- THORACIC (OCT)...

K013222 is an FDA 510(k) clearance for SUMMIT OCCIPITO-CERVICO- THORACIC (OCT)..., manufactured by Depuyacromed. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K013222 · Depuyacromed · Orthopedic device
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Nov 2001
Decision
41d
Days
Class 2
Risk

K013222 is an FDA 510(k) clearance for the SUMMIT OCCIPITO-CERVICO- THORACIC (OCT) SPINAL 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 November 7, 2001 after a review of 41 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 - K013222

510(k) Number K013222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2001
Decision Date November 07, 2001
Days to Decision 41 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
81d faster than avg
Panel avg: 122d · This submission: 41d
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 K013222.
BLACKSTONE SPINAL FIXATION SYSTEM POSTERIOR HOOKS
K013885 · Blackstone Medical, Inc. · Feb 2002
PASS SPINAL SYSTEM
K013431 · Encore Orthopedics, Inc. · Nov 2001
TRI-FIX SPINAL FIXATION SYSTEM
K013403 · Endius, Inc. · Nov 2001
PASS SPINAL SYSTEM
K013191 · Encore Orthopedics, Inc. · Oct 2001
PASS SPINAL SYSTEM
K012175 · Encore Orthopedics, Inc. · Jul 2001
ISOLA BAND CLAMP
K010972 · Depuyacromed · Jun 2001