Cleared Traditional

K090605 - CLAMPFIX

K090605 is the FDA 510(k) clearance for CLAMPFIX by Synthes (Usa). It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K090605 · Synthes (Usa) · Orthopedic device
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Nov 2009
Decision
245d
Days
Class 2
Risk

K090605 is an FDA 510(k) clearance for the CLAMPFIX. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on November 6, 2009 after a review of 245 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 Synthes (Usa) devices

Submission Details

510(k) Number K090605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2009
Decision Date November 06, 2009
Days to Decision 245 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
123d slower than avg
Panel avg: 122d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 - NKB Thoracolumbosacral Pedicle Screw System

All 659
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K090605.
XIA 4.5 SPINAL SYSTEM
K092605 · Stryker Spine · Dec 2009
VERTEX RECONSTRUCTION SYSTEM AND VERTEX SELECT RECONSTRUCTION SYSTEM
K093434 · Medtronic Sofamor Danek · Dec 2009
EXPEDIUM SPINE SYSTEM
K092473 · Depuy Spine, Inc. · Nov 2009
TSRH SPINAL SYSTEM
K093058 · Medtronic Sofamor Danek, Inc. · Oct 2009
NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM
K092287 · Nuvasive, Inc. · Oct 2009
TSRH SPINAL SYSTEM
K092676 · Medtronic Sofamor Danek, Inc. · Oct 2009