Cleared Special

K081620 - MODIFICATION TO DEPUY DELTA XTEND REVER...

K081620 is an FDA 510(k) clearance for MODIFICATION TO DEPUY DELTA XTEND REVER..., 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 21-day FDA review.

K081620 · DePuy Orthopaedics, Inc. · Orthopedic device
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Jun 2008
Decision
21d
Days
Class 2
Risk

K081620 is an FDA 510(k) clearance for the MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM. 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 June 30, 2008 after a review of 21 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 - K081620

510(k) Number K081620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2008
Decision Date June 30, 2008
Days to Decision 21 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
101d faster than avg
Panel avg: 122d · This submission: 21d
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 157
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K081620.
ARTHREX UNIVERS II SHOULDER PEGGED GLENOID
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AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS
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AEQUALIS SHOULDER FRACTURE AND SHOULDER SYSTEMS
K081707 · Tornier, Inc. · Jul 2008
ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38
K080402 · Encore Medical, L.P. · Mar 2008
ARTHREX UNIVERS II SHOULDER PROSTHESIS
K071032 · Arthrex, Inc. · Aug 2007
MODULAR HYBRID GLENOID
K060694 · Biomet Manufacturing Corp · Dec 2006