Cleared Traditional

K063139 - SPINAL STABILIZING SPHERE SYSTEM (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K063139 · Biomet Spine · Orthopedic device
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Optimized for regulatory review, auditing and printing
Apr 2007
Decision
170d
Days
Class 3
Risk

K063139 is an FDA 510(k) clearance for the SPINAL STABILIZING SPHERE SYSTEM. Classified as Intervertebral Fusion Device With Bone Graft, Solid-sphere, Lumbar (product code NVR), Class III - Premarket Approval.

Submitted by Biomet Spine (Warsaw, US). The FDA issued a Cleared decision on April 4, 2007 after a review of 170 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. High regulatory complexity profile. 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

Submission Details

510(k) Number K063139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received October 16, 2006
Decision Date April 04, 2007
Days to Decision 170 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
48d slower than avg
Panel avg: 122d · This submission: 170d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NVR Intervertebral Fusion Device With Bone Graft, Solid-sphere, Lumbar
Device Class Class 3 - Premarket Approval
Definition Intended To Be Inserted Between The Vertebral Bodies Into The Disc Space From L3 To S1 To Provide Stabilization And To Help Promote Intervertebral Body Fusion. To Be Used With Bone Graft, For Holding Bone Parts In Alignment While They Heal. Not Intended For Use In Motion-sparing, Non-fusion Procedures, Helps Promote Intervertebral Body Fusion, Please Reference: Https://www.federalregister.gov/documents/2023/03/30/2023-06566/medical-devices-orthopedic-devices-classification-of-spinal-spheres-for-use-in-intervertebral-fusion.
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.