Cleared Abbreviated

K091873 - TRYPTIK CA ANTERIOR INTERSOMATIC CERVIC...

K091873 is the FDA 510(k) clearance for TRYPTIK CA ANTERIOR INTERSOMATIC CERVIC... by Spineart. It is a Class 2 Orthopedic device (product code ODP) cleared through the Abbreviated 510(k) pathway after a 87-day FDA review.

K091873 · Spineart · Orthopedic device
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Sep 2009
Decision
87d
Days
Class 2
Risk

K091873 is an FDA 510(k) clearance for the TRYPTIK CA ANTERIOR INTERSOMATIC CERVICAL CAGE, MODELS MOS-CA 12 05-S, MOS-CA.... Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Spineart (Geneva, CH). The FDA issued a Cleared decision on September 18, 2009 after a review of 87 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Spineart devices

Submission Details

510(k) Number K091873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2009
Decision Date September 18, 2009
Days to Decision 87 days
Submission Type Abbreviated
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
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Standards-based clearance path.

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 223
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K091873.
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CALIX SPINAL IMPLANT SYSTEM
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K081611 · Nuvasive, Inc. · Oct 2008
NOVEL CERVICAL SPINAL SPACER SYSTEM
K081730 · Alphatec Spine, Inc. · Sep 2008