Cleared Traditional

K172253 - Altus Spine Cervical Interbody Fusion S...

K172253 is an FDA 510(k) clearance for Altus Spine Cervical Interbody Fusion S..., manufactured by Altus Partners, LLC. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K172253 · Altus Partners, LLC · Orthopedic device
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Nov 2017
Decision
118d
Days
Class 2
Risk

K172253 is an FDA 510(k) clearance for the Altus Spine Cervical Interbody Fusion System. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Altus Partners, LLC (West Chester, US). The FDA issued a Cleared decision on November 21, 2017 after a review of 118 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 Altus Partners, LLC devices

FDA 510(k) Submission Details - K172253

510(k) Number K172253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2017
Decision Date November 21, 2017
Days to Decision 118 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 122d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - ODP Intervertebral Fusion Device With Bone Graft, Cervical

All 246
Devices cleared under the same product code (ODP) and FDA review panel - the closest regulatory comparables to K172253.
SeaSpine Vu cPOD, Zuma-C, Complete Cervical
K172926 · SeaSpine Orthopedics Corporation · Dec 2017
COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS
K173115 · Globus Medical, Inc. · Dec 2017
NuVasive® Modulus-C Interbody System
K172676 · Nu Vasive, Incorporated · Dec 2017
Vertera Spine Cohere Cervical Interbody Fusion Device
K173030 · Nu Vasive, Incorporated · Nov 2017
CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System
K172437 · Orthofix, Inc. · Nov 2017
SCARLET AC-T
K172065 · Spineart · Sep 2017