Cleared Traditional

K101255 - ALPHATEC SPINE ANTERIOR LUMBAR PLATING ...

K101255 is the FDA 510(k) clearance for ALPHATEC SPINE ANTERIOR LUMBAR PLATING ... by Alphatec Spine, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K101255 · Alphatec Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
78d
Days
Class 2
Risk

K101255 is an FDA 510(k) clearance for the ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Alphatec Spine, Inc. (Carlsnad, US). The FDA issued a Cleared decision on July 21, 2010 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Alphatec Spine, Inc. devices

Submission Details

510(k) Number K101255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2010
Decision Date July 21, 2010
Days to Decision 78 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
44d faster than avg
Panel avg: 122d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 438
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K101255.
NUVASIVE TRAVERSE PLATE SYSTEM
K103750 · Nuvasive, Inc. · Mar 2011
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
K102820 · Alphatec Spine, Inc. · Nov 2010
SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM
K101848 · Spinal Elements, Inc. · Oct 2010
PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES
K100708 · Pioneer Surgical Technology · Jun 2010
HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES
K100614 · Blackstone Medical, Inc. · May 2010
PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS
K092474 · K2m, Inc. · Mar 2010