Cleared Traditional

Prase PEEK Anterior Cervical Interbody Spacer (K202872) - FDA 510(k) Clearance

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

K202872 · Gbs Commonwealth Co., Ltd. · Orthopedic device
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Feb 2021
Decision
129d
Days
Class 2
Risk

K202872 is an FDA 510(k) clearance for the Prase PEEK Anterior Cervical Interbody Spacer. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Gbs Commonwealth Co., Ltd. (Geumcheon-Gu, KR). The FDA issued a Cleared decision on February 4, 2021 after a review of 129 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 Gbs Commonwealth Co., Ltd. devices

Submission Details

510(k) Number K202872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2020
Decision Date February 04, 2021
Days to Decision 129 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
7d slower than avg
Panel avg: 122d · This submission: 129d
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 K202872.
Blustone Synergy Interbody Fusion System
K203520 · Blustone Synergy, LLC · Apr 2021
CONSTRUX Mini Ti Spacer System
K203342 · Orthofix, Inc. · Mar 2021
BEE HA Cage
K203444 · NGMedical GmbH · Mar 2021
BEE Cages
K200429 · NGMedical GmbH · Jan 2021
Ti3Z Cervical Interbody System
K202398 · Zavation Medical Products, LLC · Jan 2021
ZSFab Cervical Interbody System
K202488 · Zsfab, Inc. · Jan 2021