Cleared Traditional

K220875 - HAcancellous PEEK-C Porous HA PEEK Cerv...

K220875 is an FDA 510(k) clearance for HAcancellous PEEK-C Porous HA PEEK Cerv..., manufactured by Innovasis, Inc.. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K220875 · Innovasis, Inc. · Orthopedic device
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Aug 2022
Decision
154d
Days
Class 2
Risk

K220875 is an FDA 510(k) clearance for the HAcancellous PEEK-C Porous HA PEEK 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 August 26, 2022 after a review of 154 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 Innovasis, Inc. devices

FDA 510(k) Submission Details - K220875

510(k) Number K220875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2022
Decision Date August 26, 2022
Days to Decision 154 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
32d slower than avg
Panel avg: 122d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ODP Device Classification - Class 2, Special Controls

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 242
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K220875.
UniVy OsteoVy Cervical IBF System
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CONDUIT Cages
K222276 · Depuy Spine · Oct 2022
uCerv Flux-C 3D Porous Titanium Cervical Interbody
K220696 · Ulrich Medical USA · Aug 2022
Keos Anterior Cervical Interbody Fusion Device System
K212450 · Keos · Jun 2022
Reliance Cervical IBF System
K202266 · Reliance Medical Systems, LLC · Mar 2022