Cleared Traditional

K133721 - INFILL 41-TLIF CONVEX OBLIQUE DEVICE

K133721 is an FDA 510(k) clearance for INFILL 41-TLIF CONVEX OBLIQUE DEVICE, manufactured by Pinnacle Spine Group, LLC. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K133721 · Pinnacle Spine Group, LLC · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2014
Decision
116d
Days
Class 2
Risk

K133721 is an FDA 510(k) clearance for the INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL .... 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 Pinnacle Spine Group, LLC (Dallas, US). The FDA issued a Cleared decision on March 31, 2014 after a review of 116 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 Pinnacle Spine Group, LLC devices

FDA 510(k) Submission Details - K133721

510(k) Number K133721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2013
Decision Date March 31, 2014
Days to Decision 116 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
6d faster than avg
Panel avg: 122d · This submission: 116d
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 659
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K133721.
JULIET OL
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K133205 · Medtronic Sofamor Danek USA, Inc. · Mar 2014
DEROYAL SPINE SPACER SYSTEM
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