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FDA 510(k) Recap: Shoulders and Ankles

Shoulders and ankles comprise the largest share of the extremities joint reconstruction segment, which is itself just 4% of the overall orthopedic market. Though this represents a small slice of the pie, repair of the lesser joints remains an attractive area for product introductions, allowing orthopedic device companies to offer their customers more solutions. For 2018, extremities replacement device products reached nearly $2.8 billion in revenue, growing 8% over 2017, by ORTHOWORLD® estimates.

Here are highlights from FDA clearances for five shoulder devices and one ankle device granted since the beginning of the year—most from companies that you know, who wish to keep growth momentum moving forward.


Univers II Shoulder Prosthesis System: Titanium Humeral Heads | K182799

  • Submitted to FDA 10/02/2018, cleared 03/08/2019
  • Line extension, indicated for patients with suspected cobalt alloy sensitivity
  • Glenoid components are intended for cemented fixation in the joint
  • Arthrex’s shoulder replacement products include Univers Apex, Univers Revers and Univers II, supported by the company’s online Virtual Implant Positioning system for pre-op planning with patient-specific surgical instrumentation

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

AltiVate Reverse Humeral Stem 48mm | K190290

  • Submitted to FDA 02/11/2019, cleared 04/26/2019
  • Short-stem extension to the AltiVate line, which includes primary anatomic and reverse designs
  • AltiVate devices incorporate vitamin E polyethylene to maintain strength and reduce wear, as well as p2 porous coating to support bony ingrowth

Vantage Total Ankle Flat Cut Talar Components | K183343

  • Submitted to FDA 12/03/2018, cleared 04/01/2019
  • Line extension; Vantage is indicated for primary and revision procedures, both with cement
  • These proposed components are equivalent to those previously cleared under K152217 in 1Q16, but utilize one additional fixation structure and flat cut geometry on devices’ bone-contacting surface rather than a curved underlying surface featured in the predicate

ReUnion Reversible Fracture System, Reverse Shoulder Arthroplasty, Total Shoulder Arthroplasty systems | K183039

  • Submitted to FDA 11/01/2018, cleared 02/15/2019
  • Reunion systems received first 510(k) clearance in 4Q16, and are supported by TrueSight software for pre-op positioning of the pilot wire and glenoid baseplate and selection of appropriate center and peripheral screw lengths
  • Present clearance addresses new devices to be marketed within the ReUnion TSA and RSA systems, including modifications to:
    • ReUnion TSA System to add shorter length ReUnion S reduced length humeral stems
    • ReUnion TSA System to add EtO sterilized X3 glenoid components
    • ReUnion RSA System to add EtO sterilized X3 humeral inserts

Zimmer Biomet
Comprehensive Nano Stemless Shoulder | K182516

  • Submitted to FDA 09/13/2018, cleared 04/22/2019
  • For primary procedures; humeral components are porous coated and indicated for uncemented fixation
  • Appears to be the first stemless design in the Comprehensive series, joining the company’s Sidus Stem-Free shoulder that received clearance at the end of 2017 and launched in 1Q18


Sources:, company press releases, websites, information in the public domain

Julie A. Vetalice
is ORTHOWORLD’s Editorial Assistant.


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