Cleared Traditional

K122957 - TEZO TITANIUM CAGE FAMILY

K122957 is the FDA 510(k) clearance for TEZO TITANIUM CAGE FAMILY by Ulrich GmbH & Co. KG. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K122957 · Ulrich GmbH & Co. KG · Orthopedic device
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Jun 2013
Decision
269d
Days
Class 2
Risk

K122957 is an FDA 510(k) clearance for the TEZO TITANIUM CAGE FAMILY. 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 Ulrich GmbH & Co. KG (Chesterfield, US). The FDA issued a Cleared decision on June 21, 2013 after a review of 269 days - an extended review 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: 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 Ulrich GmbH & Co. KG devices

Submission Details

510(k) Number K122957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2012
Decision Date June 21, 2013
Days to Decision 269 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
147d slower than avg
Panel avg: 122d · This submission: 269d
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 604
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K122957.
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