Cleared Traditional

K141791 - BIOMET FUSION SYSTEM

K141791 is an FDA 510(k) clearance for BIOMET FUSION SYSTEM, manufactured by Biomet Spine. The device is a Class 2 Orthopedic device with product code OVD cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K141791 · Biomet Spine · Orthopedic device
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Oct 2014
Decision
99d
Days
Class 2
Risk

K141791 is an FDA 510(k) clearance for the BIOMET FUSION SYSTEM. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Biomet Spine (Broomfield, US). The FDA issued a Cleared decision on October 9, 2014 after a review of 99 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 Biomet Spine devices

FDA 510(k) Submission Details - K141791

510(k) Number K141791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2014
Decision Date October 09, 2014
Days to Decision 99 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
23d faster than avg
Panel avg: 122d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OVD Device Classification - Class 2, Special Controls

Product Code OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
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 - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 164
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K141791.
AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System
K143163 · Stryker Corporation · Jan 2015
IMPIX ALIF S/A
K141187 · Medicrea International SA · Jan 2015
AERO-LL LUMBAR CAGE SYSTEM
K142066 · Stryker Corporation · Nov 2014
IRIX-A LUMBAR INTEGRATED FUSION SYSTEM
K133947 · X-Spine Systems, Inc. · Jul 2014
COROENT XL-F SYSTEM
K140479 · Nu Vasive, Incorporated · Jul 2014
CHESAPEAKE SPINAL SYSTEM
K133494 · K2m, Inc. · Jun 2014