Cleared Traditional

K080971 - SPINESMITH CIMPLICITY SPINAL SYSTEM

K080971 is an FDA 510(k) clearance for SPINESMITH CIMPLICITY SPINAL SYSTEM, manufactured by Spine Smith Partners L.P.. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K080971 · Spine Smith Partners L.P. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
89d
Days
Class 2
Risk

K080971 is an FDA 510(k) clearance for the SPINESMITH CIMPLICITY SPINAL SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Spine Smith Partners L.P. (Austin, US). The FDA issued a Cleared decision on July 2, 2008 after a review of 89 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 Spine Smith Partners L.P. devices

FDA 510(k) Submission Details - K080971

510(k) Number K080971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2008
Decision Date July 02, 2008
Days to Decision 89 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
33d faster than avg
Panel avg: 122d · This submission: 89d
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 192
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K080971.
NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM
K090176 · Nuvasive, Inc. · Apr 2009
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
ATHLET VERTEBRAL BODY REPLACEMENT SYSTEM
K081332 · Signus Medizintechnik GmbH · Jun 2008
LDR SPINE ROI-C IMPLANT
K080728 · Ldr Spine USA · May 2008