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FDA 510(k) Recap: 10 Shoulder Implants and Technologies

We have identified nearly 50 companies that market devices for shoulder joint replacement, globally, with the majority headquartered ex-U.S. To help keep an eye on shoulder technologies cleared for U.S. marketing, we highlight 2019 clearances through September, which includes two stemless options freshly added to the lineup, like Arthrex’s Eclipse Shoulder and Zimmer Biomet’s second stemless offering, Comprehensive Nano, which gained clearance in early 2Q and joins its Sidus device in bone-sparing designs.

Arthrex 
Eclipse Shoulder Prosthesis System, K183194 (Pictured above)

  • Submitted November 2018, granted July 2019
  • Primary predicates: Arthrex Univers II, Zimmer Biomet Sidus Stem-Free, Wright Medical Simpliciti    
  • Stemless humeral joint designed as a humeral head replacement
  • Components made from Cobalt Chromium and Titanium alloy; trunnion features a titanium plasma spray Calcium Phosphate coating
  • Humeral component is fixated with a hollow screw; glenoid components are intended for cemented fixation in the joint and must only be used with appropriate bone cement
  • Compatible with pegged, keeled and VaultLock glenoids
  • Reportedly the only stemless shoulder in the U.S. that is fixated with a screw (vs. press fit)
   


Stemless Shoulders on the U.S. Market

Here is a rundown of all companies that have received FDA 510(k) clearance to market stemless shoulder implants, to date.

March 2015: Wright Medical (Tornier)
Simpliciti Shoulder System, K143552

December 2017: Zimmer Biomet (Zimmer)
Sidus Stem-Free Shoulder, K171858

March 2018: Exactech
Equinoxe Stemless Shoulder, K173388

April 2019: Zimmer Biomet (Biomet)
Comprehensive Nano Stemless Shoulder, K182516

July 2019: Arthrex
Eclipse Shoulder Prosthesis System, K183194

   
       
       

Arthrex
Univers II Shoulder Prosthesis System: Titanium Humeral Heads, K182799

  • Submitted October 2018, granted March 2019
  • Primary predicates: Zimmer Biomet (Biomet) Titanium Versa-Dial Humeral Head Prosthesis, Wright Medical (Tornier) Aequalis Ascend Flex Shoulder, Arthrex Univers II
  • Filing adds a line extension of titanium humeral heads to the Arthrex Univers II shoulder originally cleared under K07103 in 2007 with cobalt-chromium devices

Catalyst OrthoScience
CSR Press-Fit Humeral Components, K182500

  • Submitted to FDA 09/12/2018, cleared 01/11/2019
  • Bone preserving total shoulder prosthesis
  • Line extension of Press-Fit humeral implants intended for uncemented or cemented use
  • Made from Co-Cr-Mo alloy; undersurface of head and proximal portion of the alignment pegs feature a plasma-sprayed coating of CP Ti

Catalyst OrthoScience
Catalyst OrthoScience CSR Shoulder, K191811

  • Submitted July 2018, granted September 2019
  • This submission adds augmented glenoid components to the CSR Shoulder; additional material has been added to the fixation surface, creating a 10-degree posterior wedge
  • Catalyst CSR is a single-tray shoulder arthroplasty system containing a non-spherical humeral implant for consistent anatomic joint line restoration; specialized glenoid instrumentation supports a less invasive approach

DePuy Synthes
Delta Xtend Reverse Shoulder System, K183077    

  • Submitted November 2018, granted May 2019
  • Primary predicates: DePuy Synthes Delta Xtend Reverse Shoulder, Wright Medical Aequalis Reversed Prosthesis
  • Filing addresses addition of lateralized glenosphere components
  • Indicated for treatment of a grossly deficient rotator cuff joint with certain conditions
  • Also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for revision of a previously failed Delta Xtend Reverse Shoulder
  • Metaglene component is HA coated and intended for cementless use with screws
  • Modular humeral stem and humeral epiphysis components are HA coated and intended for cementless use
  • All other metallic components are intended for cemented use only

Materialise
Glenoid Positioning System, K190286

  • Submitted February 2019, granted July 2019
  • Primary predicate: Materialise Glenoid Positioning System/SurgiCase Shoulder Planner
  • Patient-specific instrumentation for shoulder arthroplasty and 3D planning software, for the positioning of glenoid components in total and reverse procedures
  • Filing extends the functionality of SurgiCase Shoulder Planner to include showing of DICOM images, graft model visualization and a humerus visualization with subluxation index

Wright Medical
Aequalis Flex Revive Shoulder System, K191318

  • Submitted May 2019, granted June 2019
  • Primary predicate: Aequalis Flex Revive Shoulder
  • Convertible anatomic and reversed shoulder arthroplasty system that is designed to be used with existing Tornier (Wright) implant systems
  • Non-constrained system intended for total or partial replacement of the glenohumeral articulation
  • Filing addresses new distal stem components to be offered in additional lengths and a partially coated format for the same intended use as the predicate device; new stems compatible with all existing components of the predicate

Wright Medical
Aequalis Ascend Flex Shoulder System, K190521

  • Submitted March 2019, granted June 2019
  • Primary predicate: Aequalis Ascend Flex Shoulder
  • Anatomic and reversed system for replacement of shoulder joints in cases of a functional deltoid muscle with massive and non-repairable rotator cuff tear
  • Filing addresses addition of 135° and 140° reversed final angle combinations and the inlay technique, in addition to the existing 145° angle without a change in implant design

Stryker
ReUnion Reversible Fracture System, Reverse Shoulder Arthroplasty System and Total Shoulder Arthroplasty System, K183039

  • Submitted November 2018, granted February 2019
  • Primary predicate: ReUnion Reversible Fracture System, Reverse Shoulder Arthroplasty System and Total Shoulder Arthroplasty System
  • Filing addresses new devices within the ReUnion TSA System and ReUnion RSA System, including modifications to add shorter-length ReUnion S humeral stems and to add ethylene oxide (EtO) sterilized X3 glenoid components to ReUnion TSA and EtO sterilized X3 humeral inserts to ReUnion RSA; predicate device is sterilized using gas plasma

Zimmer Biomet
Comprehensive Nano Stemless Shoulder, K182516 

  • Submitted September 2018, granted April 2019
  • Primary predicates: Wright Medical (Tornier) Simpliciti, Zimmer Biomet Sidus, Exactech Equinoxe Stemless Shoulder, Zimmer Biomet (Biomet) Comprehensive Primary Shoulder
  • Stemless humeral components have a porous surface coating and are indicated for uncemented biological fixation
  • Modular hybrid glenoid is intended to be implanted with bone cement; porous titanium peg may be inserted without bone cement
    Based on the clinical heritage of the Biomet T.E.S.S. (Total Evolutive Shoulder System) stemless shoulder, available in certain European and international markets since launch in 2004

Sources: Company websites, press releases, FDA.gov, information in the public domain



Julie A. Vetalice
is ORTHOWORLD's Editorial Assistant.

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