Cleared Traditional

K7 LUMBAR SPACERS (K133126) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K133126 · K7, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
70d
Days
Class 2
Risk

K133126 is an FDA 510(k) clearance for the K7 LUMBAR SPACERS. 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 K7, LLC (Chesterland, US). The FDA issued a Cleared decision on December 9, 2013 after a review of 70 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all K7, LLC devices

Submission Details

510(k) Number K133126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2013
Decision Date December 09, 2013
Days to Decision 70 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
52d faster than avg
Panel avg: 122d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 435
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K133126.
CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM
K133205 · Medtronic Sofamor Danek USA, Inc. · Mar 2014
PERIMETER C SPINAL SYSTEM, CAPSTONE SPINAL SYSTEM, CAPSTONE L SPINAL SYSTEM, PERIMETER SPINAL SYSTEM
K133645 · Medtronic Sofamor Danek USA, Inc. · Jan 2014
CAPSTONE SPINAL SYSTEM
K133650 · Medtronic Sofamor Danek USA, Inc. · Dec 2013
PERIMETER INTERBODY FUSION DEVICE
K131669 · Medtronic Sofamor Danek USA, Inc. · Nov 2013
SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS
K130478 · Globus Medical, Inc. · Jul 2013
LATIS SPACER
K123913 · Globus Medical, Inc. · May 2013