Cleared Special

K051659 - SEMIAL SPINAL IMPLANT

K051659 is an FDA 510(k) clearance for SEMIAL SPINAL IMPLANT, 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 21-day FDA review.

K051659 · Signus Medizintechnik GmbH · Orthopedic device
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Jul 2005
Decision
21d
Days
Class 2
Risk

K051659 is an FDA 510(k) clearance for the SEMIAL SPINAL IMPLANT. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Signus Medizintechnik GmbH (Minneapolis, US). The FDA issued a Cleared decision on July 13, 2005 after a review of 21 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 - K051659

510(k) Number K051659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2005
Decision Date July 13, 2005
Days to Decision 21 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
101d faster than avg
Panel avg: 122d · This submission: 21d
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 K051659.
CONCORDE VBR SPINAL SYSTEM
K052746 · Depuy Spine, Inc. · Oct 2005
MODIFICATION TO: VERTE-STACK SPINAL SYSTEM
K052261 · Medtronic Sofamor Danek USA, Inc. · Oct 2005
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT
K051978 · Implex Corp. · Sep 2005
MC+ PARTIAL VBR
K043479 · Ldr Spine USA · Jun 2005
OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI)
K043349 · Ldr Spine USA · Jun 2005
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1
K051196 · Implex Corp. · Jun 2005