Cleared Traditional

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

K121115 is the FDA 510(k) clearance for M.U.S.T PEDICLE SCREW SYSTEM by Medacta International. It is a Class 2 Orthopedic device (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

Submission Details

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.

Device Classification

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 271
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K121115.
VERTEX RECONSTRUCTION SYSTEM
K123568 · Medtronic Sofamor Danek USA, Inc. · Dec 2012
SOLSTICE CROSS CONNECTOR
K120998 · Life Spine · Oct 2012
CASIAN, 3.5/4.5 CONNECTORS
K121808 · K2m, Inc. · Jul 2012
VERTEX RCCONSTRUCTION SYSTEM
K121191 · Medtronic Sofamor Danek, Inc. · Jun 2012
OASYS SPINAL SYSTEM
K111719 · Stryker Spine · Jan 2012
CASPIAN
K113654 · K2m, Inc. · Jan 2012