Cleared Traditional

K122596 - ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS

K122596 is an FDA 510(k) clearance for ARTHROSCOPIC SURGICAL INSTRUMENTS - INT..., manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K122596 · Smith & Nephew, Inc. · Orthopedic device
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Nov 2012
Decision
88d
Days
Class 2
Risk

K122596 is an FDA 510(k) clearance for the ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on November 20, 2012 after a review of 88 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 Smith & Nephew, Inc. devices

FDA 510(k) Submission Details - K122596

510(k) Number K122596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2012
Decision Date November 20, 2012
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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 927
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K122596.
INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW)
K123672 · Inion OY · Feb 2013
MILAGRO ADVANCE INTERFERENCE SCREW
K123362 · Depuy Mitek, A Johnson & Johnson Company · Feb 2013
EMERGE MEDICAL SOLID BONE SCREWS
K122489 · Emerge Medical · Dec 2012
Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE
K121277 · Z-Medical GmbH & Co. KG · Nov 2012
GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET
K122738 · Solana Surgical, LLC · Nov 2012
HAMMER TOE IMPLANT
K122959 · Trilliant Surgical, Ltd. · Nov 2012