Cleared Traditional

KIMBA SPINAL IMPLANT (K052533) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K052533 · Signus Medizintechnik GmbH · Orthopedic device
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Optimized for regulatory review, auditing and printing
Nov 2005
Decision
49d
Days
Class 2
Risk

K052533 is an FDA 510(k) clearance for the KIMBA 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 November 3, 2005 after a review of 49 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Signus Medizintechnik GmbH devices

Submission Details

510(k) Number K052533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2005
Decision Date November 03, 2005
Days to Decision 49 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 122d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 68
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K052533.
XPAND RADIOLUCENT CORPECTOMY SPACER
K060665 · Globus Medical, Inc. · May 2006
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K060719 · Medtronic Sofamor Danek · Apr 2006
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K052931 · Medtronic Sofamor Danek · Nov 2005
MODIFICATION TO: VERTE-STACK SPINAL SYSTEM
K052261 · Medtronic Sofamor Danek USA, Inc. · Oct 2005
BASIS VERTEBRAL BODY SPACER
K051105 · Medtronic Sofamor Danek · Jun 2005
XPAND CORPECTOMY SPACER
K050850 · Globus Medical, Inc. · May 2005