Cleared Traditional

K031175 - CLICK'X MONOAXIAL SCREWS AND HOOKS

K031175 is an FDA 510(k) clearance for CLICK'X MONOAXIAL SCREWS AND HOOKS, manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K031175 · Synthes (Usa) · Orthopedic device
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Nov 2003
Decision
214d
Days
Class 2
Risk

K031175 is an FDA 510(k) clearance for the CLICK'X MONOAXIAL SCREWS AND HOOKS. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on November 14, 2003 after a review of 214 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 Synthes (Usa) devices

FDA 510(k) Submission Details - K031175

510(k) Number K031175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2003
Decision Date November 14, 2003
Days to Decision 214 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
92d slower than avg
Panel avg: 122d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 376
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K031175.
ALTIUS OCT SYSTEM
K033961 · Interpore Cross Intl. · Apr 2004
ICON POLYAXIAL PEDICLE SCREW SYSTEM
K033090 · Alphatec Mfg., Inc. · Mar 2004
BLACKSTONE ASCENT POCT SYSTEM HOOKS (SYSTEM MODIFICATION)
K033980 · Blackstone Medical, Inc. · Mar 2004
ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL01
K031471 · Ortho Tec, LLC · Oct 2003
TI FENESTRATED PLATE
K031772 · Interpore Cross Intl. · Sep 2003
MODIFICATION ORIA SPINAL SYSTEM
K023884 · Ortho Tec, LLC · Aug 2003