Cleared Traditional

K081501 - SOLITAIRE ANTERIOR SPINAL SYSTEM

K081501 is an FDA 510(k) clearance for SOLITAIRE ANTERIOR SPINAL SYSTEM, manufactured by Biomet Spine. The device is a Class 2 Orthopedic device with product code OVD cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K081501 · Biomet Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
34d
Days
Class 2
Risk

K081501 is an FDA 510(k) clearance for the SOLITAIRE ANTERIOR SPINAL SYSTEM. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Biomet Spine (Parsippany, US). The FDA issued a Cleared decision on July 2, 2008 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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 Biomet Spine devices

FDA 510(k) Submission Details - K081501

510(k) Number K081501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2008
Decision Date July 02, 2008
Days to Decision 34 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
88d faster than avg
Panel avg: 122d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OVD Device Classification - Class 2, Special Controls

Product Code OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
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 - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 164
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K081501.
LUCENT MAGNUM+
K081711 · Spinal Elements, Inc. · Sep 2008
BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE
K081849 · Blackstone Medical, Inc. · Aug 2008
VU APOD INTERVERTABRAL BODY FUSION DEVICE
K080822 · Theken Spine, LLC · Jul 2008
SOLITAIRE PEEK-OPTIMA ANTERIOR SPINAL SYSTEM
K081395 · Biomet Spine · Jun 2008