Cleared Special

K073105 - PEEK SPINAL SPHERES (FDA 510(k) Clearance)

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

K073105 · Interbody Innovations, Llp · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
62d
Days
Class 3
Risk

K073105 is an FDA 510(k) clearance for the PEEK SPINAL SPHERES. Classified as Intervertebral Fusion Device With Bone Graft, Solid-sphere, Lumbar (product code NVR), Class III - Premarket Approval.

Submitted by Interbody Innovations, Llp (Round Rock, US). The FDA issued a Cleared decision on January 3, 2008 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

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 Interbody Innovations, Llp devices

Submission Details

510(k) Number K073105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received November 02, 2007
Decision Date January 03, 2008
Days to Decision 62 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 122d · This submission: 62d
Pathway characteristics
Modification to existing cleared device.

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.