Cleared Special

K092122 - GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID

K092122 is an FDA 510(k) clearance for GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID, manufactured by DePuy Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code KWS cleared through the Special 510(k) pathway after a 13-day FDA review.

K092122 · DePuy Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
13d
Days
Class 2
Risk

K092122 is an FDA 510(k) clearance for the GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 27, 2009 after a review of 13 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 DePuy Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K092122

510(k) Number K092122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2009
Decision Date July 27, 2009
Days to Decision 13 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 faster than avg
Panel avg: 122d · This submission: 13d
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 156
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K092122.
AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM
K103007 · Tornier, Inc. · Nov 2010
EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD.
K093430 · Exactech, Inc. · Sep 2010
GRS GLENOID RESURFACING SYSTEM
K091196 · Arthrosurface, Inc. · Oct 2009
DEPUY DELTA XTEND REVERSE SHOULDER XLK CUP
K091751 · DePuy Orthopaedics, Inc. · Jul 2009
ARTHREX UNIVERS II SHOULDER PEGGED GLENOID
K083435 · Arthrex, Inc. · Jun 2009
AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS
K082120 · Tornier · Oct 2008