Cleared Special

K172674 - Sapphire Cervical Implant System

K172674 is an FDA 510(k) clearance for Sapphire Cervical Implant System, manufactured by Sapphire Medical Group. The device is a Class 2 Orthopedic device with product code ODP cleared through the Special 510(k) pathway after a 58-day FDA review.

K172674 · Sapphire Medical Group · Orthopedic device
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Nov 2017
Decision
58d
Days
Class 2
Risk

K172674 is an FDA 510(k) clearance for the Sapphire Cervical Implant System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Sapphire Medical Group (Dana Point, US). The FDA issued a Cleared decision on November 2, 2017 after a review of 58 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 Sapphire Medical Group devices

FDA 510(k) Submission Details - K172674

510(k) Number K172674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2017
Decision Date November 02, 2017
Days to Decision 58 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 122d · This submission: 58d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Spineworks, LLC
Marshall McCarty

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 352
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K172674.
Vertera Spine Cohere Cervical Interbody Fusion Device
K173030 · Nu Vasive, Incorporated · Nov 2017
SPIRA-C Open Matrix Cervical Interbody
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CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System
K172437 · Orthofix, Inc. · Nov 2017
SCARLET AC-T
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Shanghai Sanyou PEEK Cage System
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Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers
K172587 · Medacta International S.A. · Sep 2017