Cleared Special

K230583 - Tryptik Ti

K230583 is the FDA 510(k) clearance for Tryptik Ti by Spineart SA. It is a Class 2 Orthopedic device (product code ODP) cleared through the Special 510(k) pathway after a 20-day FDA review.

K230583 · Spineart SA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
20d
Days
Class 2
Risk

K230583 is an FDA 510(k) clearance for the Tryptik Ti. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Spineart SA (Plan-Les-Ouates, CH). The FDA issued a Cleared decision on March 22, 2023 after a review of 20 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 Spineart SA devices

Submission Details

510(k) Number K230583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2023
Decision Date March 22, 2023
Days to Decision 20 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 122d · This submission: 20d
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 219
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K230583.
NEST-C Interbody System
K220261 · Paonan Biotech Co., Ltd. · Apr 2023
UniVy™ OsteoVy™-Ti Cervical IBF System
K223513 · Vy Spine, LLC · Apr 2023
SQUALE
K230026 · Implanet, S.A. · Mar 2023
The Integrity Spine Core System
K223043 · Integrity Spine · Mar 2023
Ti-Largo Cervical Interbody System
K223231 · Flospine · Feb 2023
Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system
K213755 · Gbs Commonwealth Co., Ltd. · Feb 2023