Cleared Traditional

K063139 - SPINAL STABILIZING SPHERE SYSTEM

K063139 is an FDA 510(k) clearance for SPINAL STABILIZING SPHERE SYSTEM, manufactured by Biomet Spine. The device is a Class 3 Orthopedic device with product code NVR cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K063139 · Biomet Spine · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K063139

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 122d · This submission: 170d
Pathway characteristics
Predicate-based equivalence.

NVR Device Classification - Class 3, Premarket Approval

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.

Regulatory Peers - NVR Intervertebral Fusion Device With Bone Graft, Solid-sphere, Lumbar

Devices cleared under the same product code (NVR) and FDA review panel - the closest regulatory comparables to K063139.
SPINAL SPHERE SYSTEM
K073274 · Life Spine · Mar 2008
PEEK SPINAL SPHERES
K073105 · Interbody Innovations, Llp · Jan 2008
SPINAL SPHERES
K062992 · Interbody Innovations, Llp · Jul 2007
MODIFICATION TO: SATELLITE SPINAL SYSTEM
K060415 · Medtronic Sofamor Danek · Jan 2007
SATELLITE SPINAL SYSTEM
K051320 · Medtronic Sofamor Danek · Sep 2005