Cleared Traditional

K151785 - Px HA PEEK IBF System

K151785 is an FDA 510(k) clearance for Px HA PEEK IBF System, manufactured by Innovasis, Inc.. The device is a Class 2 Orthopedic device with product code MAX cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K151785 · Innovasis, Inc. · Orthopedic device
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Oct 2015
Decision
105d
Days
Class 2
Risk

K151785 is an FDA 510(k) clearance for the Px HA PEEK IBF System. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Innovasis, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 14, 2015 after a review of 105 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 Innovasis, Inc. devices

FDA 510(k) Submission Details - K151785

510(k) Number K151785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2015
Decision Date October 14, 2015
Days to Decision 105 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
17d faster than avg
Panel avg: 122d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAX Device Classification - Class 2, Special Controls

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

All 853
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K151785.
PIVOX(tm) Oblique Lateral Spinal System
K152277 · Medtronic Sofamor Danek USA, Inc. · Nov 2015
Integrity Spine Lumbar Interbody Fusion System
K151819 · Integrity Spine Lumbar Interbody Fusion System · Nov 2015
Opticage Expandable Interbody Fusion Device
K152156 · Interventional Spine, Inc. · Oct 2015
CONCORDE Bullet Spinal System
K151352 · Medos International SARL · Oct 2015
Valeo Spacer System and Valeo II Interbody Fusion Device System
K143518 · Amedica Corp. · Oct 2015
LOSPA IS Spinal System
K151408 · Corentec Co., Ltd. · Oct 2015