Cleared Traditional

Atlas Spine Rebar (Ti) Spacer System (K202302) - FDA 510(k) Clearance

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

K202302 · Atlas Spine, Inc. · Orthopedic device
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Oct 2020
Decision
77d
Days
Class 2
Risk

K202302 is an FDA 510(k) clearance for the Atlas Spine Rebar (Ti) Spacer System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Atlas Spine, Inc. (Jupiter, US). The FDA issued a Cleared decision on October 30, 2020 after a review of 77 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 Atlas Spine, Inc. devices

Submission Details

510(k) Number K202302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2020
Decision Date October 30, 2020
Days to Decision 77 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 122d · This submission: 77d
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 182
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K202302.
Tailored-C Cervical Interbody Fusion System
K200458 · Bespoke Technologies · Dec 2020
ChoiceSpine Tiger Shark Cervical Spacer System
K201643 · Choice Spine, LLC · Dec 2020
Lucero Medical Cervical Cage System
K200549 · Lucero Medical, LLC · Dec 2020
CONSTRUX Mini PEEK Spacer System
K202949 · Orthofix, Inc. · Oct 2020
CONSTRUX Mini PTC Spacer System
K202666 · Orthofix, Inc. · Oct 2020
Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System
K201506 · Meditech Spine, LLC · Sep 2020