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FDA 510(k) Recap: Large Players Notch Sports Medicine and Orthobiologics Clearances

Of the 45 products cleared under FDA’s orthopedic panel in June 2019, none were from companies gaining their first ortho-related clearance. Lacking the chance to share a new find with you, let’s take the time to recognize two segments that don’t get a lot of coverage in these clearance recaps (and in which large ortho players received clearances in June): sports medicine and orthobiologics.

We value the sports medicine market at $5.6 billion and the orthobiologics market at $5.1 billion. Here are important things to know about these two segments.

  • The sports medicine market is controlled by Arthrex (34%) and Smith & Nephew (23%). DePuy Synthes ranks at #3 with 12% market share. Hundreds of smaller players occupy the remaining 31%.
  • The orthobiologics market is fragmented in its technology and players due to its breadth of applications. Main players are a mix of traditional implant companies—Medtronic, DePuy Synthes—and pure-play orthobiologics companies—Sanofi, MTF Biologics.

The pie chart below presents all 45 June clearances by segment. As you'll observe, sports medicine and orthobiologics represent the smallest slices.

June 2019 510k

 Now, we’ll look at the products making up those small pie slices. 

Sports Medicine

Arthrex | SwiveLock Suture Anchor, K191226

  • Filed May 2019
  • For fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow and hip
  • SwiveLock devices have been gaining clearances since 2011; this traditional 510(k) premarket notification is submitted to obtain anterior cruciate ligament repair indications for the Arthrex SwiveLock Anchors cleared under K180768, K171141 and K151342

CONMED | MicroLink All-Suture Button Fixation System (Radiolucent), K190516; MicroLink All-Suture Button Fixation System (Radiopaque), K190582 

    conmed Microlink2
    CONMED MicroLink All-Suture 
Button Fixation System
     
    • Filed March 2019
    • Indicated for fixation of bone-to-bone as an adjunct in Carpometacarpal Suspension in the hand
    • All-suture suspension device with one strand of #2 Hi-Fi suture, a radiolucent flat braid Hi-Fi Suture Button and a radiolucent flat braid Hi-Fi suture Backstop threaded on a loader
    • Claims to be the world’s first all-suture button
    • Trapezium pin is compatible with power for easy insertion; features a laser line for indicating accurate drill depth into trapezium
    • Suture passing drill features a coined tip to combine tunnel drilling and suture passing into one step with minimal bone removal

    DePuy Synthes | HEALIX ADVANCE Anchor with DYNA+TAPE Sutures, K191483

    • Filed June 2019
    • For fixation of soft tissue to bone in the shoulder, foot/ankle, knee, elbow and hip
    • Anchors available in absorbable Biocryl Rapide and non-absorbable PEEK
    • Joins other HEALIX ADVANCE designs featuring PERMATAPE, DYNACORD

    HydroCision | TenJet Device, K190804

    hydrocision tenjet
    HydroCision TenJet Device
    • Filed March 2019
    • Single-use disposable device intended for use when the cutting, debridement and removal of soft and hard tissue is required in a variety of open, arthroscopic and minimally invasive surgical procedures
    • Supply kit contains sterile packaged, single-use OEM surgical supply items for use in site preparation and closure
    • Physicians can view changes in tendon pathology in real-time with ultrasound, direct or arthroscopic visualization
    • Procedure is performed in an outpatient setting under a local anesthetic in approximately 15 minutes

    Medacta | MectaScrew PEEK Interference Screw, K190892

    • Filed April 2019
    • Indicated for reconstructive treatment of ruptured anterior and posterior cruciate ligaments by means of autografts and allografts
    • Portfolio includes 19 configurations ranging in diameter from 6mm to 12mm and 15mm to 35mm in length
    • Part of the company’s gradual entry into the U.S. soft tissue repair/sports medicine market, following the M-ARS ACL: Anatomic Ribbon Surgery System (cleared in late 2017) and MectaLock PEEK Suture Anchor (cleared May 2019)

    Orthobiologics

    Geistlich Pharma | Orthoss Bone Void Filler, K190754

    • Filed March 2019
    • Intended to fill bony voids or gaps of the skeletal system (extremities, posterolateral spine and pelvis) 
    • Can be used with autograft as a bone graft extender in posterolateral spine fusion
    • Bovine bone, provided in block or granular formats
    • Since prior clearance of the device in 2010 (K090401), the following minor changes were made: change from an aluminum vial cap to a polyethylene vial cap; slight changes in manufacturing and processes; addition of alternative raw material supplier; addition of a new filling volume of 1mm - 2mm, 1 g and packaging change for granules from glass vial in a peel pouch to glass vial in blister pack

    Zimmer Knee Creations | AccuFill Bone Substitute Material, K190814

    • Filed March 2019
    • Injectable, self-setting, macroporous, osteoconductive, calcium phosphate bone graft substitute intended to fill bony voids or gaps of the skeletal (extremities, posterolateral spine and pelvis)
    • In 2017, was introduced ex-U.S. as part of the Subchondroplasty procedure to fill defects associated with subchondral bone marrow lesions

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



    Julie A. Vetalice
    is ORTHOWORLD’s Editorial Assistant.

     

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