Cleared Traditional

K121136 - RENOIR POSTERIOR CERVIAL FIXATION SYSTEM

K121136 is an FDA 510(k) clearance for RENOIR POSTERIOR CERVIAL FIXATION SYSTEM, manufactured by Accel Spine. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K121136 · Accel Spine · Orthopedic device
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Aug 2012
Decision
118d
Days
Class 2
Risk

K121136 is an FDA 510(k) clearance for the RENOIR POSTERIOR CERVIAL FIXATION SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Accel Spine (Dallas, US). The FDA issued a Cleared decision on August 9, 2012 after a review of 118 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Accel Spine devices

FDA 510(k) Submission Details - K121136

510(k) Number K121136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2012
Decision Date August 09, 2012
Days to Decision 118 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
4d faster than avg
Panel avg: 122d · This submission: 118d
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 337
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K121136.
PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM
K121725 · Pioneer Surgical Technology, Inc. · Nov 2012
RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM
K122292 · Reliance Medical Systems, LLC · Oct 2012
SOLSTICE CROSS CONNECTOR
K120998 · Life Spine · Oct 2012
CASIAN, 3.5/4.5 CONNECTORS
K121808 · K2m, Inc. · Jul 2012
M.U.S.T PEDICLE SCREW SYSTEM
K121115 · Medacta International · Jul 2012
VERTEX RCCONSTRUCTION SYSTEM
K121191 · Medtronic Sofamor Danek, Inc. · Jun 2012