Cleared Traditional

K102323 - CERVICAL STANDALONE INTERVERTEBRAL BODY...

K102323 is an FDA 510(k) clearance for CERVICAL STANDALONE INTERVERTEBRAL BODY..., manufactured by Theken Spine, LLC. The device is a Class 2 Orthopedic device with product code OVE cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K102323 · Theken Spine, LLC · Orthopedic device
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Dec 2010
Decision
121d
Days
Class 2
Risk

K102323 is an FDA 510(k) clearance for the CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Theken Spine, LLC (Akron, US). The FDA issued a Cleared decision on December 16, 2010 after a review of 121 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Theken Spine, LLC devices

FDA 510(k) Submission Details - K102323

510(k) Number K102323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2010
Decision Date December 16, 2010
Days to Decision 121 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
1d faster than avg
Panel avg: 122d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OVE Device Classification - Class 2, Special Controls

Product Code OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical 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 - OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 124
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K102323.
AVS ANCHOR-C CERVICAL CAGE SYSTEM
K102606 · Stryker Spine · Apr 2011
COROENT INTERLOCK SYSTEM
K102547 · Nuvasive, Inc. · Feb 2011
SYNTHES ZERO-P
K093762 · Synthes Spine · Dec 2010
PEEK PREVAIL CERVICAL INTERBODY DEVICE
K094042 · Medtronic Sofamor Danek · Jun 2010
ZUMA-C
K092521 · Seaspine, Inc. · Apr 2010
COALITION SPACER
K083389 · Globus Medical, Inc. · Mar 2009