Cleared Traditional

K122738 - GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET

K122738 is an FDA 510(k) clearance for GAITWAY IMPLANT SYSTEM, manufactured by Solana Surgical, LLC. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K122738 · Solana Surgical, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K122738

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
Combination Product No
PCCP Authorized No
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.

HWC Device Classification - Class 2, Special Controls

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 1052
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K122738.
EMERGE MEDICAL SOLID BONE SCREWS
K122489 · Emerge Medical · Dec 2012
ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS
K122596 · Smith & Nephew, Inc. · Nov 2012
Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE
K121277 · Z-Medical GmbH & Co. KG · Nov 2012
HAMMER TOE IMPLANT
K122959 · Trilliant Surgical, Ltd. · Nov 2012
NEXTRA TI HAMMERTOE CORRECTION SYSTEM
K122031 · Nextremity Solutions, LLC · Oct 2012
ACTIVE SCREW BONE SCREW
K121682 · Intelligent Implant Systems, LLC · Oct 2012