Cleared Special

Peridot-PT Anterior Cervical Intervertebral body fusion System (K233839) - FDA 510(k) Clearance

Also marketed or referenced as:
Peridot-PT Intervertebral body fusion system The Peridot-TD Anterior Cervical Intervertebral body fusion system The Peridot-TD Intervertebral body fusion system

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K233839 · Gbs Commonwealth Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2023
Decision
16d
Days
Class 2
Risk

K233839 is an FDA 510(k) clearance for the Peridot-PT Anterior Cervical Intervertebral body fusion System. 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 December 20, 2023 after a review of 16 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Gbs Commonwealth Co., Ltd. devices

Submission Details

510(k) Number K233839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2023
Decision Date December 20, 2023
Days to Decision 16 days
Submission Type Special
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
106d faster than avg
Panel avg: 122d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

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 K233839.
MATRIX HA PEEK Cervical IBF System
K232619 · Sapphire Medical Group · Mar 2024
Tranquil-C Interbody System
K240416 · Nexus Spine, LLC · Mar 2024
BEE Cervical Cage
K231371 · NGMedical GmbH · Jan 2024
Align Cervical Interbody Fusion System
K230639 · Acuity Surgical Devices, LLC · Dec 2023
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