Cleared Special

AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM (K103007) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K103007 · Tornier, Inc. · Orthopedic device
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Nov 2010
Decision
28d
Days
Class 2
Risk

K103007 is an FDA 510(k) clearance for the AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Tornier, Inc. (Beverly, US). The FDA issued a Cleared decision on November 9, 2010 after a review of 28 days - a notably fast clearance 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. 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.

View all Tornier, Inc. devices

Submission Details

510(k) Number K103007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2010
Decision Date November 09, 2010
Days to Decision 28 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 92
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K103007.
ARTHREX UNIVERS II SHOULDER PROSTHESIS
K103466 · Arthrex, Inc. · Dec 2010
EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM
K103419 · Exactech, Inc. · Dec 2010
SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT
K103104 · Howmedica Osteonics Corp. · Nov 2010
EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD.
K093430 · Exactech, Inc. · Sep 2010
GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID
K092122 · DePuy Orthopaedics, Inc. · Jul 2009
DEPUY DELTA XTEND REVERSE SHOULDER XLK CUP
K091751 · DePuy Orthopaedics, Inc. · Jul 2009