Cleared Traditional

K160958 - Battalion Universal Spacer System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K160958 · Alphatec Spine · Orthopedic device
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Sep 2016
Decision
156d
Days
Class 2
Risk

K160958 is an FDA 510(k) clearance for the Battalion Universal Spacer System. Classified as Intervertebral Fusion Device With Bone Graft, Thoracic (product code PHM), Class II - Special Controls.

Submitted by Alphatec Spine (Carlsnad, US). The FDA issued a Cleared decision on September 8, 2016 after a review of 156 days - an extended review cycle.

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 Alphatec Spine devices

Submission Details

510(k) Number K160958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2016
Decision Date September 08, 2016
Days to Decision 156 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
34d slower than avg
Panel avg: 122d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PHM Intervertebral Fusion Device With Bone Graft, Thoracic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Thoracic 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.