Cleared Traditional

K222973 - IdentiTi and Transcend Interbody System...

K222973 is the FDA 510(k) clearance for IdentiTi and Transcend Interbody System... by Alphatec Spine, Inc.. It is a Class 2 Orthopedic device (product code ODP) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K222973 · Alphatec Spine, Inc. · Orthopedic device
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Nov 2022
Decision
50d
Days
Class 2
Risk

K222973 is an FDA 510(k) clearance for the IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interb.... Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on November 17, 2022 after a review of 50 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 Alphatec Spine, Inc. devices

Submission Details

510(k) Number K222973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2022
Decision Date November 17, 2022
Days to Decision 50 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 122d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODP Intervertebral Fusion Device With Bone Graft, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical 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 - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 218
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K222973.
Cervical Spine Truss System (CSTS) Interbody Fusion Device
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