Cleared Traditional

K101310 - VU APOD INTERVERTEBRAL BODY FUSION DEVICE

K101310 is an FDA 510(k) clearance for VU APOD INTERVERTEBRAL BODY FUSION DEVICE, manufactured by Theken Spine, LLC. The device is a Class 2 Orthopedic device with product code OVD cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K101310 · Theken Spine, LLC · Orthopedic device
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Sep 2010
Decision
114d
Days
Class 2
Risk

K101310 is an FDA 510(k) clearance for the VU APOD INTERVERTEBRAL BODY FUSION DEVICE. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Theken Spine, LLC (Washington, US). The FDA issued a Cleared decision on September 2, 2010 after a review of 114 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 - K101310

510(k) Number K101310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2010
Decision Date September 02, 2010
Days to Decision 114 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
8d faster than avg
Panel avg: 122d · This submission: 114d
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 158
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K101310.
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
COROENT XLR STANDALONE SYSTEM
K100043 · Nuvasive, Inc. · Jun 2010
CHESAPEAKE SPINAL SYSTEM
K092211 · K2m, Inc. · Mar 2010
LIFE SPINE STAND-ALONE SPACER SYSTEM
K091301 · Life Spine · Dec 2009