Cleared Traditional

K121191 - VERTEX RCCONSTRUCTION SYSTEM

K121191 is an FDA 510(k) clearance for VERTEX RCCONSTRUCTION SYSTEM, manufactured by Medtronic Sofamor Danek, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K121191 · Medtronic Sofamor Danek, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
71d
Days
Class 2
Risk

K121191 is an FDA 510(k) clearance for the VERTEX RCCONSTRUCTION SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek, Inc. (Memphis, US). The FDA issued a Cleared decision on June 29, 2012 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 Medtronic Sofamor Danek, Inc. devices

FDA 510(k) Submission Details - K121191

510(k) Number K121191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2012
Decision Date June 29, 2012
Days to Decision 71 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
51d faster than avg
Panel avg: 122d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 383
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K121191.
RENOIR POSTERIOR CERVIAL FIXATION SYSTEM
K121136 · Accel Spine · Aug 2012
CASIAN, 3.5/4.5 CONNECTORS
K121808 · K2m, Inc. · Jul 2012
M.U.S.T PEDICLE SCREW SYSTEM
K121115 · Medacta International · Jul 2012
NEXTGEN ALTIUS OCT SYSTEM
K113593 · Biomet Spine (Aka Ebi, LLC) · Apr 2012
REXIOUS HOOK FIXATION SYSTEMS
K113324 · Dio Medical Co., Ltd. · Mar 2012
PIONEER POSTERIOR CERVICO THORACIC SYSTEM
K112757 · Pioneer Surgical Technology, Inc. · Mar 2012