Cleared Traditional

K043316 - RABEA SPINAL IMPLANT

K043316 is an FDA 510(k) clearance for RABEA SPINAL IMPLANT, manufactured by Signus Medizintechnik GmbH. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K043316 · Signus Medizintechnik GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
67d
Days
Class 2
Risk

K043316 is an FDA 510(k) clearance for the RABEA 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 February 7, 2005 after a review of 67 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

FDA 510(k) Submission Details - K043316

510(k) Number K043316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2004
Decision Date February 07, 2005
Days to Decision 67 days
Submission Type Traditional
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
55d faster than avg
Panel avg: 122d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K043316.
FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE
K051000 · Spinal Concepts, Inc. · May 2005
STRYKER SPINE AVS PL PEEK SPACER
K050624 · Stryker Spine · Apr 2005
STRYKER SPINE AVS TL PEEK SPACER
K042571 · Stryker Spine · Feb 2005
NUVASIVE COROENT SYSTEM
K043405 · Nuvasive, Inc. · Feb 2005
PIONEER VERTEBRAL BODY REPLACEMENT DEVICE (PIONEER VERTEBRAL SPACER)
K043206 · Pioneer Surgical Technology · Jan 2005
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K043566 · Medtronic Sofamor Danek · Jan 2005