Cleared Special

K081332 - ATHLET VERTEBRAL BODY REPLACEMENT SYSTEM

K081332 is an FDA 510(k) clearance for ATHLET VERTEBRAL BODY REPLACEMENT SYSTEM, manufactured by Signus Medizintechnik GmbH. The device is a Class 2 Orthopedic device with product code MQP cleared through the Special 510(k) pathway after a 29-day FDA review.

K081332 · Signus Medizintechnik GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
29d
Days
Class 2
Risk

K081332 is an FDA 510(k) clearance for the ATHLET VERTEBRAL BODY REPLACEMENT SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Signus Medizintechnik GmbH (Chesterland, US). The FDA issued a Cleared decision on June 10, 2008 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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.

View all Signus Medizintechnik GmbH devices

FDA 510(k) Submission Details - K081332

510(k) Number K081332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2008
Decision Date June 10, 2008
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

MQP Device Classification - Class 2, Special Controls

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - MQP Spinal Vertebral Body Replacement Device

All 189
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K081332.
LDR SPINE ROI-C IMPLANT
K083857 · Ldr Spine USA · Feb 2009
T2 XVBR SPINAL SYSTEM
K082112 · Medtronic Sofamor Danek · Aug 2008
RELIANCE VBS SYSTEM
K081383 · Reliance Medical Systems, LLC · Jul 2008
LDR SPINE ROI-C IMPLANT
K080728 · Ldr Spine USA · May 2008
NOVEL SPINAL SPACER SYSTEM
K080699 · Alphatec Spine, Inc. · May 2008
LDR SPINE ROI-T IMPLANT
K080569 · Ldr Spine USA · May 2008