Cleared Special

K102090 - SPINESMITH CYNCH SPINAL SYSTEM - VISUAL...

K102090 is an FDA 510(k) clearance for SPINESMITH CYNCH SPINAL SYSTEM - VISUAL..., manufactured by Spine Smith Partners L.P.. The device is a Class 2 Orthopedic device with product code OVD cleared through the Special 510(k) pathway after a 66-day FDA review.

K102090 · Spine Smith Partners L.P. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
66d
Days
Class 2
Risk

K102090 is an FDA 510(k) clearance for the SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Spine Smith Partners L.P. (Austin, US). The FDA issued a Cleared decision on September 30, 2010 after a review of 66 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.

View all Spine Smith Partners L.P. devices

FDA 510(k) Submission Details - K102090

510(k) Number K102090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2010
Decision Date September 30, 2010
Days to Decision 66 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 122d · This submission: 66d
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 160
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K102090.
INTERCONTINENTAL PLATE-SPACER
K103382 · Globus Medical, Inc. · May 2011
VAULT ALIF SYSTEM
K103369 · Spinal USA · Apr 2011
SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM
K102402 · Alphatec Spine, Inc. · Mar 2011
VU APOD INTERVERTEBRAL BODY FUSION DEVICE
K101310 · Theken Spine, LLC · Sep 2010
COROENT XLR STANDALONE SYSTEM
K100043 · Nuvasive, Inc. · Jun 2010
CHESAPEAKE SPINAL SYSTEM
K092211 · K2m, Inc. · Mar 2010