Cleared Special

K081707 - AEQUALIS SHOULDER FRACTURE AND SHOULDER...

K081707 is an FDA 510(k) clearance for AEQUALIS SHOULDER FRACTURE AND SHOULDER..., manufactured by Tornier, Inc.. The device is a Class 2 Orthopedic device with product code KWS cleared through the Special 510(k) pathway after a 30-day FDA review.

K081707 · Tornier, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
30d
Days
Class 2
Risk

K081707 is an FDA 510(k) clearance for the AEQUALIS SHOULDER FRACTURE AND SHOULDER SYSTEMS. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Tornier, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 17, 2008 after a review of 30 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

FDA 510(k) Submission Details - K081707

510(k) Number K081707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2008
Decision Date July 17, 2008
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
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 153
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K081707.
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
MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM
K081620 · DePuy Orthopaedics, Inc. · Jun 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