Cleared Traditional

K082914 - CLAMPFIX

K082914 is the FDA 510(k) clearance for CLAMPFIX by Synthes Spine. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K082914 · Synthes Spine · Orthopedic device
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Dec 2008
Decision
72d
Days
Class 2
Risk

K082914 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 Spine (West Chester, US). The FDA issued a Cleared decision on December 11, 2008 after a review of 72 days - a notably fast clearance 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: 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 Synthes Spine devices

Submission Details

510(k) Number K082914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2008
Decision Date December 11, 2008
Days to Decision 72 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
50d faster than avg
Panel avg: 122d · This submission: 72d
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 668
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K082914.
EXPEDIUM SPINE SYSTEM
K090230 · Depuy Spine, Inc. · Mar 2009
MERCURY SPINAL SYSTEM
K082353 · Spinal Elements, Inc. · Jan 2009
REVOLVE STABILIZATION SYSTEM
K083416 · Globus Medical, Inc. · Jan 2009
MERCURY SPINAL SYSTEM
K083230 · Spinal Elements, Inc. · Dec 2008
USS ILIOSACRAL, USS POLYAXIAL
K082572 · Synthes Spine · Nov 2008
TSRH SPINAL SYSTEM
K081080 · Medtronic Sofamor Danek · Nov 2008