Cleared Traditional

K102067 - ENDOSKELETON TO

K102067 is an FDA 510(k) clearance for ENDOSKELETON TO, manufactured by Titan Spine, LLC. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K102067 · Titan Spine, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
105d
Days
Class 2
Risk

K102067 is an FDA 510(k) clearance for the ENDOSKELETON TO. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Titan Spine, LLC (Apple Valley, US). The FDA issued a Cleared decision on November 5, 2010 after a review of 105 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.

FDA 510(k) Submission Details - K102067

510(k) Number K102067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2010
Decision Date November 05, 2010
Days to Decision 105 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
17d faster than avg
Panel avg: 122d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAX Device Classification - Class 2, Special Controls

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize 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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 898
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K102067.
GENESYS SPINE INTERBODY FUSION SYSTEM
K103034 · Genesys Spine · Dec 2010
PATRIOT TRANSCONTINENTAL M SPACERS
K102313 · Globus Medical, Inc. · Dec 2010
CONCORDE CURVE SYSTEM
K101923 · Depuy Spine · Dec 2010
INTERFUSE T INVERTEBRAL BODY FUSION DEVICE
K102277 · Vertebral Technologies, Inc. · Oct 2010
DIFUSION TECHNOLOGIES XIPHOS INTERBODY FUSION SYSTEM
K100042 · Difusion Technologies · Oct 2010
STALIF MIDLINE
K101301 · Centinel Spine · Sep 2010
K102067 · ENDOSKELETON TO
Download PDF FDA Summary Titan Spine, LLC