Cleared Special

K112438 - TITAN MODULAR TOTAL SHOULDER SYSTEM

K112438 is an FDA 510(k) clearance for TITAN MODULAR TOTAL SHOULDER SYSTEM, manufactured by Ascension Orthopedic. The device is a Class 2 Orthopedic device with product code KWS cleared through the Special 510(k) pathway after a 231-day FDA review.

K112438 · Ascension Orthopedic · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
231d
Days
Class 2
Risk

K112438 is an FDA 510(k) clearance for the TITAN MODULAR TOTAL SHOULDER SYSTEM. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Ascension Orthopedic (Austin, US). The FDA issued a Cleared decision on April 11, 2012 after a review of 231 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - 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. Standard predicate reliance. 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 - K112438

510(k) Number K112438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2011
Decision Date April 11, 2012
Days to Decision 231 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
109d slower than avg
Panel avg: 122d · This submission: 231d
Pathway characteristics
Modification to existing cleared device.

KWS Device Classification - Class 2, Special Controls

Product Code KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
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 - KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

All 187
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K112438.
EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT
K121220 · Exactech, Inc. · Nov 2012
ASCEND SHOULDER SYSTEM
K121493 · Tornier, Inc. · Jun 2012
ASCEND SHOULDER SYSTEM
K120794 · Tornier, Inc. · Apr 2012
ASCEND SHOULDER SYSTEM
K113413 · Tornier, Inc. · Mar 2012
ARTHREX UNIVERSII XL GLENOID-PEGGED, ARTHREX UNIVERS II XL GLENOID-KEELED
K120044 · Arthrex, Inc. · Mar 2012
PROMOS MODULAR SHOULDER SYSTEM
K113012 · Smith & Nephew, Inc. · Jan 2012