Cleared Traditional

K110197 - EXACTECH GIBRALT SPINAL SYSTEM

K110197 is an FDA 510(k) clearance for EXACTECH GIBRALT SPINAL SYSTEM, manufactured by Exactech, Inc.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K110197 · Exactech, Inc. · Orthopedic device
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Jul 2011
Decision
172d
Days
Class 2
Risk

K110197 is an FDA 510(k) clearance for the EXACTECH GIBRALT SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on July 15, 2011 after a review of 172 days - an extended review 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: 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 Exactech, Inc. devices

FDA 510(k) Submission Details - K110197

510(k) Number K110197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2011
Decision Date July 15, 2011
Days to Decision 172 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
50d slower than avg
Panel avg: 122d · This submission: 172d
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 265
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K110197.
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K111127 · Spineart · Aug 2011
MESA SPINAL SYSTEM (KEYSTONE RODS)
K110991 · K2m, Inc. · Aug 2011
VENUS CERVICAL SPINAL FIXATION SYSTEM
K103414 · L & K Biomed Co., Ltd. · Jul 2011
NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM
K110284 · Medyssey Co, Ltd. · Jun 2011
ZENIUS SPINAL SYSTEM
K110283 · Medyssey Co, Ltd. · May 2011
EVEREST SPINAL SYSTEM
K103440 · K2m, Inc. · Mar 2011