Cleared Traditional

K101363 - VU CPOD INTERVERTEBRAL BODU FUSION DEVICE

K101363 is an FDA 510(k) clearance for VU CPOD INTERVERTEBRAL BODU FUSION DEVICE, manufactured by Musculoskeletal Clinical Regulatory Advisers. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K101363 · Musculoskeletal Clinical Regulatory Advisers · Orthopedic device
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Dec 2010
Decision
216d
Days
Class 2
Risk

K101363 is an FDA 510(k) clearance for the VU CPOD INTERVERTEBRAL BODU FUSION DEVICE. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Musculoskeletal Clinical Regulatory Advisers (Washington, US). The FDA issued a Cleared decision on December 16, 2010 after a review of 216 days - an extended review 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: 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 Musculoskeletal Clinical Regulatory Advisers devices

FDA 510(k) Submission Details - K101363

510(k) Number K101363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2010
Decision Date December 16, 2010
Days to Decision 216 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 122d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODP Device Classification - Class 2, Special Controls

Product Code ODP Intervertebral Fusion Device With Bone Graft, 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.
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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 267
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K101363.
ALEUTTIAN
K103169 · K2m, Inc. · Mar 2011
LANX CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
K103660 · Lanx, Inc. · Feb 2011
ORTHOVITA PEEK SPACER
K101171 · Orthovita, Inc. · Jan 2011
SMALL PLATEAU SPACER SYSTEM
K093093 · Life Spine · Oct 2010
CONSTRUX MINI PEEK SPACER SYSTEM
K101812 · Orthofix, Inc. · Sep 2010
ALEUTIAN IBF SYSTEM
K101302 · K2m, Inc. · Jul 2010