Cleared Abbreviated

K122021 - STERISPINE LC CAGE

K122021 is the FDA 510(k) clearance for STERISPINE LC CAGE by Safe Orthopaedics. It is a Class 2 Orthopedic device (product code MAX) cleared through the Abbreviated 510(k) pathway after a 72-day FDA review.

K122021 · Safe Orthopaedics · Orthopedic device
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Sep 2012
Decision
72d
Days
Class 2
Risk

K122021 is an FDA 510(k) clearance for the STERISPINE LC CAGE. 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 Safe Orthopaedics (Eragny Sur Oise, FR). The FDA issued a Cleared decision on September 20, 2012 after a review of 72 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Safe Orthopaedics devices

Submission Details

510(k) Number K122021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2012
Decision Date September 20, 2012
Days to Decision 72 days
Submission Type Abbreviated
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 122d · This submission: 72d
Pathway characteristics
Standards-based clearance path.

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 577
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K122021.
FALCON SPACER
K123180 · Synthes USA Products, LLC · Jan 2013
PATRIOT SPACERS
K122097 · Globus Medical, Inc. · Dec 2012
COUGAR LS 15 LATERAL CAGE SYSTEM
K122896 · Medos International SARL · Oct 2012
CLYDESDALE SPINAL SYSTEM
K122591 · Medtronic Sofamor Danek, Inc. · Sep 2012
CAPSTONE SPINAL SYSTEM
K121760 · Medtronic Sofamor Danek USA, Inc. · Aug 2012
VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
K121096 · L & K Biomed Co., Ltd. · Jul 2012