Cleared Special

K113107 - MSA HIP SYSTEM

K113107 is an FDA 510(k) clearance for MSA HIP SYSTEM, manufactured by Global Manufacturing Technology. The device is a Class 2 Orthopedic device with product code MEH cleared through the Special 510(k) pathway after a 56-day FDA review.

K113107 · Global Manufacturing Technology · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
56d
Days
Class 2
Risk

K113107 is an FDA 510(k) clearance for the MSA HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by Global Manufacturing Technology (Washington, US). The FDA issued a Cleared decision on December 15, 2011 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K113107

510(k) Number K113107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2011
Decision Date December 15, 2011
Days to Decision 56 days
Submission Type Special
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
66d faster than avg
Panel avg: 122d · This submission: 56d
Pathway characteristics
Modification to existing cleared device.

MEH Device Classification - Class 2, Special Controls

Product Code MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

All 158
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K113107.
CORIN TRIFIT TS HIP
K121563 · Corin USA · Oct 2012
MODULAR PROXIMALLY FLUTED HIP STEM
K113789 · Smith & Nephew, Inc. · Apr 2012
NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12
K113320 · Exactech, Inc. · Mar 2012
ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS
K112556 · Howmedica Osteonics Corp. · Sep 2011
NOVEL TAPERED HIP STEM
K103479 · Stryker Corp. · Mar 2011
CERAMIC FEMORAL HEAD
K103497 · United Orthopedic Corp. · Mar 2011
K113107 · MSA HIP SYSTEM
Download PDF FDA Summary Global Manufacturing …