Cleared Traditional

K160154 - ALTA Anterior Cervical Interbody Spacer

K160154 is an FDA 510(k) clearance for ALTA Anterior Cervical Interbody Spacer, manufactured by Astura Medical. The device is a Class 2 Orthopedic device with product code ODP cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K160154 · Astura Medical · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
114d
Days
Class 2
Risk

K160154 is an FDA 510(k) clearance for the ALTA Anterior Cervical Interbody Spacer. Classified as Intervertebral Fusion Device With Bone Graft, Cervical (product code ODP), Class II - Special Controls.

Submitted by Astura Medical (Carlsbad, US). The FDA issued a Cleared decision on May 13, 2016 after a review of 114 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.

FDA 510(k) Submission Details - K160154

510(k) Number K160154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2016
Decision Date May 13, 2016
Days to Decision 114 days
Submission Type Traditional
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
8d faster than avg
Panel avg: 122d · This submission: 114d
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 Consultant

The OrthoMedix Group, Inc.
J.D. Webb

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 K160154.
InterForm Cervical Interbody Cage System
K161608 · Next Orthosurgical · Sep 2016
Ascential IBD PEEKc Spacer
K161407 · Stryker Spine · Jul 2016
AnyPlus® Cervical PEEK Cage System
K153517 · GS Medical Co., Ltd. · Jun 2016
Cervical Interbody Fusion System
K160324 · Evolution Spine, LLC · May 2016
Cascadia Interbody System
K160125 · K2m · Apr 2016
ANATOMIC PEEK PTC Cervical Fusion System
K160528 · Medtronic Sofamor Danek USA, Inc. · Mar 2016