Cleared Special

K082732 - MODIFICATION TO: CAPSTONE SPINAL SYSTEM

K082732 is an FDA 510(k) clearance for MODIFICATION TO: CAPSTONE SPINAL SYSTEM, manufactured by Medtronic Sofamor Danek USA, Inc.. The device is a Class 2 Orthopedic device with product code MAX cleared through the Special 510(k) pathway after a 28-day FDA review.

K082732 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
28d
Days
Class 2
Risk

K082732 is an FDA 510(k) clearance for the MODIFICATION TO: CAPSTONE SPINAL 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 Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on October 16, 2008 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K082732

510(k) Number K082732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2008
Decision Date October 16, 2008
Days to Decision 28 days
Submission Type Special
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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 898
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K082732.
LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICE
K082774 · Lanx, LLC · Oct 2008
INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES
K082260 · Calvary Spine, LLC · Oct 2008
SPINAL USA VBR SYSTEM
K081196 · Spinal USA · Oct 2008
OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM
K082270 · Vertiflex, Inc. · Sep 2008
MODIFICATION TO CAPSTONE SPINAL SYSTEM
K082342 · Medtronic Sofamor Danek · Sep 2008
BLACKSTONE PILLAR XL PEEK SPACERS
K082235 · Blackstone Medical, Inc. · Sep 2008
K082732 · MODIFICATION TO: CAPSTONE SPINAL SYSTEM
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