Cleared Traditional

K231899 - HAtetracell-C Titanium Cervical IBF System

K231899 is the FDA 510(k) clearance for HAtetracell-C Titanium Cervical IBF System by Innovasis, Inc.. It is a Class 2 Orthopedic device (product code ODP) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K231899 · Innovasis, Inc. · Orthopedic device
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Oct 2023
Decision
111d
Days
Class 2
Risk

K231899 is an FDA 510(k) clearance for the HAtetracell™-C Titanium Cervical IBF System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Innovasis, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 17, 2023 after a review of 111 days - within the typical 510(k) review window.

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 Innovasis, Inc. devices

Submission Details

510(k) Number K231899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2023
Decision Date October 17, 2023
Days to Decision 111 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
11d faster than avg
Panel avg: 122d · This submission: 111d
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 215
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K231899.
Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system
K233084 · Gbs Commonwealth Co., Ltd. · Nov 2023
ClariVy™ Cervical IBF System
K231836 · Vy Spine, LLC · Oct 2023
Acro Composites Interbody System
K230478 · Acro Composites, LLC · Oct 2023
Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system)
K232822 · Gbs Commonwealth Co., Ltd. · Oct 2023
VariLift®-C Interbody Fusion System
K231076 · Wenzel Spine, Inc. · Sep 2023
neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical
K222988 · Ht Medical D.B.A. Xenix Medical · Sep 2023