Cleared Traditional

PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEM (K123207) - FDA 510(k) Clearance

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

K123207 · Osteomed LP · Orthopedic device
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Nov 2012
Decision
48d
Days
Class 2
Risk

K123207 is an FDA 510(k) clearance for the PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEM. 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 Osteomed LP (Addison, US). The FDA issued a Cleared decision on November 29, 2012 after a review of 48 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 Osteomed LP devices

Submission Details

510(k) Number K123207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2012
Decision Date November 29, 2012
Days to Decision 48 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
74d faster than avg
Panel avg: 122d · This submission: 48d
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 K123207.
OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE STRAIGHT I/R - LORDOTIC
K130434 · Exactech, Inc. · May 2013
CALIBER SPACERS
K123231 · Globus Medical, Inc. · Jan 2013
PATRIOT SPACERS
K122097 · Globus Medical, Inc. · Dec 2012
CAPSTONE SPINAL SYSTEM
K121760 · Medtronic Sofamor Danek USA, Inc. · Aug 2012
CAPSTONE CONTROL SPINAL SYSTEM
K120368 · Medtronic Sofamor Danek USA, Inc. · Apr 2012
RISE SPACER
K113447 · Globus Medical, Inc. · Jan 2012