Cleared Special

K120557 - SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35

K120557 is an FDA 510(k) clearance for SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-T..., manufactured by Biomet Spine & Bone Healing Technologies. The device is a Class 2 Orthopedic device with product code OVD cleared through the Special 510(k) pathway after a 24-day FDA review.

K120557 · Biomet Spine & Bone Healing Technologies · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
24d
Days
Class 2
Risk

K120557 is an FDA 510(k) clearance for the SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Biomet Spine & Bone Healing Technologies (Parsippany, US). The FDA issued a Cleared decision on March 19, 2012 after a review of 24 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K120557

510(k) Number K120557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2012
Decision Date March 19, 2012
Days to Decision 24 days
Submission Type Special
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
98d faster than avg
Panel avg: 122d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 203
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K120557.
SOVEREIGN SPINAL SYSTEM
K121982 · Medtronic Sofamor Danek · Jul 2012
VU APOD INTERVERTEBRAL BODY FUSION DEVICE
K121211 · Theken Spine, LLC · Jun 2012
INDEPENDENCE SPACER
K120101 · Globus Medical, Inc. · Mar 2012
CHESAPEAKE SPINAL SYSTEM
K120031 · K2m, Inc. · Mar 2012
NUVASIVE COROENT NO-PROFILE SYSTEM
K112561 · Nuvasive, Inc. · Mar 2012
SOVEREIGN SPINAL SYSTEM
K110063 · Medtronic Sofamor Danek, Inc. · Oct 2011
K120557 · SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35
Download PDF FDA Summary Biomet Spine & Bone H…