Cleared Traditional

GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET (K122738) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K122738 · Solana Surgical, LLC · Orthopedic device
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Nov 2012
Decision
62d
Days
Class 2
Risk

K122738 is an FDA 510(k) clearance for the GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Solana Surgical, LLC (Memphis, US). The FDA issued a Cleared decision on November 7, 2012 after a review of 62 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 Solana Surgical, LLC devices

Submission Details

510(k) Number K122738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2012
Decision Date November 07, 2012
Days to Decision 62 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
60d faster than avg
Panel avg: 122d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 402
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K122738.
ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM
K130810 · Zimmer, Inc. · Sep 2013
MEDLINE CANNULATED SCREW
K130319 · Medline Industries, Inc. · May 2013
ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS
K122596 · Smith & Nephew, Inc. · Nov 2012
PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION
K120645 · Wrightmedicaltechnologyinc · Apr 2012
ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY
K112885 · Zimmer, Inc. · Dec 2011
SI-LOK SACROILIAC JOINT FIXATION SYSTEM
K112028 · Globus Medical, Inc. · Dec 2011