Cleared Traditional

K061229 - UNITY LX ANTEROLATERAL LUMBAR PLATE FIX...

K061229 is the FDA 510(k) clearance for UNITY LX ANTEROLATERAL LUMBAR PLATE FIX... by Blackstone Medical, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K061229 · Blackstone Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
83d
Days
Class 2
Risk

K061229 is an FDA 510(k) clearance for the UNITY LX ANTEROLATERAL LUMBAR PLATE FIXATION SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Blackstone Medical, Inc. (Wayne, US). The FDA issued a Cleared decision on July 24, 2006 after a review of 83 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 Blackstone Medical, Inc. devices

Submission Details

510(k) Number K061229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2006
Decision Date July 24, 2006
Days to Decision 83 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
39d faster than avg
Panel avg: 122d · This submission: 83d
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 K061229.
TRINICA ANTERIOR LUMBAR PLATE SYSTEM
K061353 · Zimmer Spine, Inc. · Aug 2006
REFLEX HYBRID ACP SYSTEM
K062310 · Stryker Spine · Aug 2006
LATERAL PLATE SYSTEM
K061789 · Nuvasive, Inc. · Aug 2006
OPTERYX ANTERIOR CERVICAL PLATE SYSTEM
K061147 · Innovasis, Inc. · Jun 2006
VENTURE ANTERIOR CERVICAL PLATE SYSTEM
K061274 · Medtronic Sofamor Danek · May 2006
EBI ANTERIOR CERVICAL PLATE SYSTEM
K060379 · Ebi, L.P. · Mar 2006