Cleared Traditional

K121115 - M.U.S.T PEDICLE SCREW SYSTEM

K121115 is an FDA 510(k) clearance for M.U.S.T PEDICLE SCREW SYSTEM, manufactured by Medacta International. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K121115 · Medacta International · Orthopedic device
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Jul 2012
Decision
97d
Days
Class 2
Risk

K121115 is an FDA 510(k) clearance for the M.U.S.T PEDICLE SCREW SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Medacta International (Camarillo, US). The FDA issued a Cleared decision on July 18, 2012 after a review of 97 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 Medacta International devices

FDA 510(k) Submission Details - K121115

510(k) Number K121115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2012
Decision Date July 18, 2012
Days to Decision 97 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
25d faster than avg
Panel avg: 122d · This submission: 97d
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 384
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K121115.
NEXTGEN ALTIUS OCT SYSTEM
K122378 · Biomet Spine (Aka Ebi, LLC) · Sep 2012
RENOIR POSTERIOR CERVIAL FIXATION SYSTEM
K121136 · Accel Spine · Aug 2012
CASIAN, 3.5/4.5 CONNECTORS
K121808 · K2m, Inc. · Jul 2012
VERTEX RCCONSTRUCTION SYSTEM
K121191 · Medtronic Sofamor Danek, Inc. · Jun 2012
NEXTGEN ALTIUS OCT SYSTEM
K113593 · Biomet Spine (Aka Ebi, LLC) · Apr 2012
REXIOUS HOOK FIXATION SYSTEMS
K113324 · Dio Medical Co., Ltd. · Mar 2012