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FDA 510(k) Highlights from 2018: Shoulder and Ankle Joint Replacement Products on Tap

So often when covering 510(k)s of interest, I’m writing about spine. This time, let’s pay attention to the strong growth segments of ankle and shoulder replacement.

The extremities replacement market is largely driven by sales of shoulder and ankle devices, and remains a reliable source of revenue for the segment’s players, surpassing $2 billion in 2017 and growing 8% annually, according to ORTHOWORLD® estimates. Top 10 companies in this space include Zimmer Biomet, DePuy Synthes, Wright Medical, DJO Surgical, Exactech, Stryker, Arthrosurface, LimaCorporate, Smith & Nephew and Mathys, in order by revenue.

Performance is not just charged by devices, but also by supplemental tech. For example, in 3Q18, Wright Medical’s upper extremity sales increased nearly 20% year-over-year, buoyed by strong growth in the company’s U.S. shoulder sales; the third quarter also saw continued adoption of BLUEPRINT 3D planning software, with 30% of the company’s shoulder cases using the system, up from 20% in the previous quarter. Wright is actively developing additional modules for the platform, including augmented reality, artificial intelligence and inter-op guidance.

According to Orthopedic Network News (ONN), the number of U.S. shoulder replacement procedures was estimated to be over 161,000 in 2017, up 9.6% vs. 2016, making shoulder arthroplasty the fastest-growing subsegment in recon devices—likely due to increasing surgeon familiarity with reverse procedures.

For ankle and subtalar procedures, again quoting ONN, U.S. procedures rose from ~7,400 in 2016 to ~8,300 in 2017, an increase of 11.1%. It would seem that an active and aging population seeks to maintain mobility when tackling climbing walls, tennis courts, golf courses and grandchild-wrangling, and who could blame them? The success of knee and hip reconstruction appears to be playing out to other joints in need of carpentry—which is good news.  

Several of the 2018 clearances shared below reflect additions of stemless/short stem, glenoid components and reverse applications, as well as additively-manufactured and porous/porous-coated designs. These allow companies to offer a wider array in the bag for customers.

These are primarily companies that you know—though some names may be less familiar. Let’s look at the products that will fuel extremities reconstruction growth in coming quarters, and contemplate how these will affect the extremities recon revenue that we’ll share in next year’s ORTHOPAEDIC INDUSTRY ANNUAL REPORT®.

Arthrex

Arthrex Shoulder System | K171841

  • Clearance for modification to device labeling, including the “MR Conditional” statement in accordance with the FDA Guidance, “Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance Environment;” addresses Univers II, Univers Apex and Univers Revers shoulders

Univers Revers Modular Glenoid System | K173900

  • Indicated for primary, fracture or revision procedures; porous-coated and cementless

Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay | K182039

  • Glenoid component of the existing Univers Revers Shoulder or Univers II; indicated for primary, fracture or revision procedures; porous-coated and cementless

Arthrosurface

OVOMotion Shoulder Arthroplasty System | K173964

  • For hemiarthroplasty or for use with company’s UHMWPE polyethylene Inlay Glenoid
  • Combines anatomic restoration with an aspherical head
  • Humeral and glenoid components for cemented use only
  • Intended to be the first of a three-element modular stemless system that will ultimately allow surgeons to intra-operatively choose among stemless, traditional and reverse options
  • As opposed to an onlay, the inlay is designed to significantly reduce glenoid loosening by eliminating the “rocking horse” effect

Catalyst OrthoScience

CSR 3 Peg Glenoid | K173812 (shown above)

  • Bone preserving UHMWPE product; to be used with the Catalyst CSR Shoulder, cemented
  • An alternative to the 2-peg device; the implant uses a backside-anchoring element for immediate interference fixation in the strongest regions of the glenoid
  • Equipped with tapered walls on the bearing surface to reduce the effects of eccentric loading, which can contribute to implant loosening

CSR Shoulder | K181287

  • Bone preserving total shoulder, cemented
  • Submission adds larger, standard/non-spherical humeral components to the CSR system

DePuy Synthes

GLOBAL UNITE Platform Shoulder System | K170748

  • For cemented or uncemented total or hemi-shoulder arthroplasty
  • This submission adds the GLOBAL UNITE Reverse Fracture Epiphysis to the currently cleared GLOBAL UNITE Platform Shoulder, as well as expands the currently cleared IFU for the entire GLOBAL UNITE Platform Shoulder system
  • Includes new porous-coated titanium alloy reverse fracture epiphyseal bodies that mate with existing GLOBAL UNITE or DELTA XTEND stems
  • By our estimates, DePuy Synthes reported extremities joint replacement revenue of $386.5MM in 2017, accounting for 5% of the company’s total orthopaedic revenue.

Exactech

Equinoxe Stemless Shoulder | K173388

  • Bone- and canal-sparing implant, additively manufactured from Ti-6Al-4V, with porous regions
  • For press-fit, uncemented use with cemented Equinoxe glenoid components
  • Alongside Zimmer Biomet’s Sidus and Wright Medical’s Simpliciti, Equinoxe is one of the only FDA-cleared stemless shoulders on the U.S. market; it achieved clearance without an Investigational Device Exemption (IDE), which allows a device to be used in a clinical study in order to collect safety and effectiveness data. (Sidus and Simpliciti were cleared by FDA with IDEs.)

Equinoxe Small Reverse Shoulder System | K180632

  • Comprises small reverse glenoid plates and glenospheres, screw components, humeral liners and surgical instrumentation
  • Modifications in this submission relate to minor geometry changes to the predicate Equinoxe Reverse Shoulder

Fournitures Hospitalieres

ARROW Reverse Porous Glenoid | K171789

  • Designed to articulate with the ARROW Reverse shoulder
  • Humeral stem for cemented or cementless use; glenoid baseplate (metal-backed or porous) intended for cementless use with bone screws for fixation
  • Company’s shoulder line includes the ARROW universal prosthesis, resurfacing cup and STS fracture system

Integra LifeSciences

TITAN Reverse Shoulder | K173717 and K181999

  • Indicated for primary fractures including proximal humeral, or revision total shoulder replacement
  • Semi-constrained construct; glenoid base plate intended for cementless use with screws for fixation; humeral stem for cemented or uncemented use and the humeral body component is intended for cementless use
  • Submissions modify the coating on the baseplate and body, changing from vacuum-sintered titanium Asymmatrix to titanium plasma spray; as well as a line extension to include additional options for baseplates, glenospheres and screws
  • TITAN Reverse originally cleared in 2016
  • Integra markets a range of implants for shoulder, ankle, wrist, elbow and digit joint replacement. By ORTHOWORLD estimates, Integra posted extremities joint replacement revenue of $22.6MM in 2017, representing 21% of the company’s overall orthopaedic revenue.

Medacta

Short Humeral Diaphysis | K180089

  • For replacement of the humeral side of the gleno-humeral joint, for use with Medacta Shoulder and Anatomic Shoulder prostheses
  • Submission addresses the shorter length design of the implant

Shoulder Innovations

InSet Short Humeral Stem | K173824

  • The assembled humeral component may be used alone for hemiarthroplasty or be combined with the InSet glenoid component for bone-sparing total shoulder arthroplasty
  • Glenoid component is intended for cemented fixation; humeral stem may be implanted by press-fit or cement fixation
  • Proximal body and fins feature a proprietary rough porous coating for uncemented fixation or for use with bone cement
  • In October, the company closed a $2.5MM round of Series A equity funding to support new product development and growth of its InSet platform, including acquisition of inventory and assets

Stryker

ReUnion Reversible Fracture, Reverse Shoulder and Total Shoulder Arthroplasty systems | K181742

  • While the summary documentation for this clearance is not presently available on FDA’s site, I presume that this submission addressed additional components for the ReUnion system that was originally cleared in 2016
  • Stryker markets implants to reconstruct extremities including shoulder, elbow, wrist, thumb, hand and ankle. By ORTHOWORLD estimates, the company posted extremities joint replacement revenue of $115.1MM in 2017, accounting for nearly 2% of total orthopaedic revenue.

Wright Medical

Aequalis Flex Revive Shoulder System | K181420

  • In anatomic procedures, the proximal body, stem, assembly screw, locking cap, optional spacers and humeral head may be used together for hemiarthroplasty or with the glenoid component for total shoulder; also cleared for conversion from anatomic to reverse

INFINITY Total Ankle System | K172633 and K181557

  • Submissions address two-piece and three-piece fixed-bearing bone-sparing prostheses cleared for total and revision procedures, cemented (in the U.S.)
  • Talar dome is additively manufactured in the two-piece design; tibial tray is additively manufactured in the three-piece
  • First clearance for INFINITY Ankle occurred in 2013

INVISION Total Ankle Revision System | K180730

  • Two-piece fixed-bearing modular system, comprising tibial stem, tray, domes and plates with a poly insert for total and revision procedures, cemented (in the U.S.)
  • Submission addressed talar fixation line extension components for the talar construct, for use in revision with the talar domes
  • In 1Q18, company commenced U.S. launch of INVISION PROPHECY Preoperative Navigation, reportedly the first pre-op planning system with patient-specific instrumentation for ankle revision; the planning system is now available for use with INFINITY, INBONE or INVISION devices per patient need
  • Wright Medical is the only company to receive FDA 510(k) clearance for total ankle products within 2018 (so far!).
  • Wright markets joint reconstruction implants to treat the shoulder, elbow, ankle and digits. By our estimates, the company posted 2017 extremities joint replacement revenue of $338.3MM, accounting for 45% of its total revenue.

Zimmer Biomet

Comprehensive Augmented Glenoid Components, Standard and Mini Baseplates | K172502

  • For primary, fracture or revision total shoulder replacement
  • Submission addressed manufacturing of an alternate version of existing Comprehensive Standard and Mini Baseplates/components with porous plasma spray (PPS) coating applied by an outside vendor, with the addition of Zimmer’s Calcicoat plasma spray technology coating; no design change
  • The new Comprehensive Reverse Augmented Baseplate has an augmented backside while retaining the existing Comprehensive Reverse baseplate geometry; is manufactured with PPS coating applied by a vendor plus Zimmer Calcicoat

Comprehensive Reverse Shoulder System | K181611

  • Indicated for primary, fracture, or revision total shoulder replacement
  • Line extension submission addresses newly-designed 36mm and 40mm trays, liners and a 40mm glenosphere; highly cross-linked ultrahigh molecular weight polyethylene liners are offered either in Prolong (standard) or Vivacit-E

Comprehensive Segmental Revision System (SRS) | K173411

  • Can be used for total and reverse shoulder replacement and distal humeral (elbow) replacement, cemented or cementless (with cement in distal humeral and total humeral applications)
  • Submission addresses expansion of indications to include reverse shoulder
  • Tissue attachment augments offer option for tissue stabilization and attachment
  • Zimmer Biomet markets implants to reconstruct extremities including ankle, shoulder and elbow. By ORTHOWORLD estimates, the company posted extremities joint replacement revenue of $405.7MM in 2017, accounting for nearly 6% of total orthopaedic revenue.

Sources: Company press releases and websites, FDA.gov, Orthopedic Network News, ORTHOWORLD estimates

Photo courtesy of Catalyst OrthoScience



Julie A. Vetalice is the Editorial Assistant for ORTHOWORLD. Reach her by
email.

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