FDA 510(k) Recap: 2020 Highlights Across the Market Segments

Close to 550 orthopedic products received clearances in this hectic year, allowing us to keep this popular monthly 510(k) recap relevant. Here are 10 clearances that I found to be of interest throughout 2020. They span first clearances, 510(k)s from startups and ex-U.S. locations. Some date back to January; another came in as recently as November. We’ll continue to keep an eye on clearances, in response to your desire to meet up-and-comers seeking to make waves in future days.

Joint Replacement

Biocore9 | Humeral Resurfacing System, K193122

  • First FDA 510(k) clearance
  • Submitted November 2019, granted May 2020
  • Primary predicate: Endotec Buechel-Pappas Humeral Head Resurfacing Component, K992394
  • Indicated for hemi-arthroplasty only
  • Components are available in five sizes with outside diameters from 40mm to 56mm in 4mm increments
  • Porous-coated components are for cemented use only
  • About the company:
    • Formed in 2017, based in Whippany, New Jersey
    • Developed Biocore9 C-TiN-C coating using the latest improvements in thin film ceramic coatings technology, lean manufacturing methods and the application of proven design concepts and manufacturing principles

Optimotion Implants | Optimotion Blue Total Knee, K191084

  • First 510(k) clearance
  • Submitted April 2019, granted April 2020
  • Primary predicates: Consensus Orthopedics PS2 Knee, K16051; Stryker Triathlon Tritanium Tibial Baseplates, K123486; Stryker Triathlon Total Knee, K051380
  • Indicated for total and revision procedures, cemented or uncemented
  • The Porous Tibial Trays and the Porous Femoral Components have porous coatings on the majority of the bone contacting surfaces to maximize interface, coverage for biological fixation; the Porous Tibial Tray is additively manufactured to include an Ultra-Porous Technology
  • Optimized for ambulatory care centers
  • About the company:
    • Established in Florida in 2016
    • Surgeon-founded; an associate has experience at Lincotek Medical and Wright Medical

Spine

Additive Implants | SureMAX-X Cervical Spacer, K193359

  • Submitted December 2019, granted January 2020
  • Primary predicate: Additive Implants Cervical Spacer, K182477
  • 3D-printed titanium alloy spacers for anterior intervertebral body fusion
  • About the company:
    • Established 2015 in Phoenix, Arizona
    • Leadership brings experience from Anulex, Danek, J&J Ethicon, Kyphon, Medtronic, Scient’x, Smith+Nephew, Zimmer Spine
    • Company was one of 10 awardees in the Spring 2019 Arizona Innovation Challenge, a business plan competition that advances innovation and technology commercialization opportunities in Arizona by helping early-stage ventures achieve scale

Axis Spine Technologies | Axis Spine Technologies ALIF, K200352

  • First FDA 510(k) clearance
  • Submitted February 2020, granted May 2020
  • Primary predicate: Custom Spine Optimus ALIF System, K132596
  • Used to treat Degenerative Disc Disease at one or two contiguous levels from L2 to S1, with supplemental fixation and bone graft
  • About the company:
    • Founded in 2017, based in St. Albans, Hertfordshire, England
    • Developed a platform technology of build-in situ modular cages as an alternative to conventional cage designs
    • With its technology, modular endplates are inserted in a closed position, atraumatically helping to preserve the structural integrity of the vertebral endplate
    • Received £830,000 (~USD $1.0 million) in new funding in 2Q20 to bring products to the spine market, with an initial focus on the U.S.
    • Leadership brings experience from ApaTech, DePuy International, NuVasive

Trauma

Armis Biopharma | VeriFixx Small Bone Implant, K202777

  • First 510(k) clearance
  • Submitted September 2020, granted November 2020
  • Indicated for fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe
  • Designed to support shorter time to ambulation, shorter overall recovery time and reduced pain
  • Employs an alignment fin design and a sub-micron layer of titanium molecularly bonded to a PEEK implant using atomic fusion deposition; designed to provide ideal fixation alignment and a bone-friendly surface, while retaining PEEK’s biocompatibility, modulus of elasticity similar to bone and radiographic visibility
  • About the company:
    • Established in 1997, based in Fort Collins, Colorado
    • Lead technology, Veriox, is a proprietary peracid/hydrogen peroxide-based non-systemic, non-resistant antimicrobial agent featuring a novel Mechanism of Action designed to reduce the likelihood of contributing to resistance against Gram+, Gram-, viral, fungal and chemical/biological warfare pathogens
    • Pursuing three Veriox-containing medical products for uses in wound, orthopedic and dermatology markets
    • Following this clearance, company intends to develop a Veriox-based coating which may be used on a wide variety of orthopedic implants
    • Leadership brings experience from Johnson & Johnson, Medtronic

Retrofix Screws | RetroFix Cannulated Screw, K200226

  • Company’s first 510(k) clearance
  • Submitted January 2020, granted June 2020
  • Primary predicate: Arthrosurface Bone Screws, K172383
  • Cannulated titanium alloy tapered screw intended for use as a stand-alone bone screw for internal fixation of ankle bone fractures
  • About the company:
    • Formed in 2017, based in Salisbury, North Carolina

Sports Medicine

Acuitive Technologies | CITREGEN Tendon Interference Screw and CITRELOCK, K200725

  • First 510(k) clearance
  • Submitted March 2020, granted October 2020
  • Primary predicate: Arthrex Tenodesis Family, K051726
  • CITREGEN material is a new-generation FDA-cleared thermoset bioresorbable synthetic polymer
  • CITREGEN is designed to replicate the intrinsic cellular biochemical and structural support network; its main component, citrate, is a naturally occurring anti-microbial and anti-inflammatory molecule that regulates cellular metabolic processes and the formation of mineral structures
  • CITREGEN leaves behind a biomimetic ceramic structure to be metabolized by host tissue; bioresorption avoids the potential for bulk degradation and chronic inflammation as opposed to current biodegradable polymers
  • CITRELOCK is indicated for fixation of ligaments or tendon graft tissue repairs of the shoulder, elbow, wrist, hand, knee, ankle and foot
  • Will be offered with both reusable or single-use instruments, in a full range of device sizes; product launch is slated for early 2021
  • About the company:
    • Established in 2013, based in Allendale, New Jersey
    • Leadership brings experience at Accellent, Biomet, Howmedica, Implex, Pipeline Orthopedics, Stryker Mako, Stryker Orthopaedics, Stryker Osteonics, Tyber Medical, Zimmer

CoNextions Medical | Coronet Soft Tissue Fixation System, K200028

  • First 510(k) clearance
  • Submitted January 2020, granted March 2020
  • Primary predicate: Ziptek ZipE Knotless Tissue Repair and Attachment Devices (K162429)
  • Intended for various applications throughout the anatomy: shoulder, elbow, hand/wrist, knee, foot/ankle
  • Single-use, sterile stainless steel and ultra-high molecular weight polyethylene implant comprising an anchor and soft tissue washer, connected via a continuous loop of suture, pre-assembled to an inserter
  • Drill bit allows for creation of a properly sized pilot hole in the bone implantation site
  • Designed to improve the soft tissue fixation strength of repairs vs. use of conventional sutures; delivery system allows for simultaneous placement of the implant in the bone and soft tissue with a knotless repair
  • About the company:
    • Founded in Salt Lake City, Utah in 2011
    • Raised $10.4 million in five rounds between 2014 and 2018
    • Leadership brings experience from Amedica, Biomet, Centerpulse, Stryker Trauma & Extremities

Orthobiologics

Linacol Medical | CureOs TCP Synthetic Resorbable Calcium Phosphate Bone Void Filler, K191670

  • First 510(k) clearance
  • Submitted June 2019, granted August 2020
  • Primary predicate: Kasios Biomaterials Kasios TCP, K042340
  • About the company:
    • Established in 2007, based in Ankara, Turkey
    • Company’s graft formats include cube, HTO and block

Sirakoss | Osteo3 ZP Putty, K193075

  • First 510(k) clearance
  • Submitted November 2019, granted June 2020
  • Primary predicate: Medtronic Sofamor Danek USA, MASTERGRAFT Strip and Putty, K140375
  • Entirely synthetic, nanoporous bone graft substitute comprising novel inorganic granules suspended in a fully synthetic resorbable carrier that can be used directly from the pack
  • Indicated for filling bone voids or defects of the skeletal system (extremities, pelvis, posterolateral spine) that are not intrinsic to the stability of the bony structure
  • Must be used with morselized autograft bone at a ratio of 1:1 by volume in the posterolateral spine
  • Osteo3 Granules gained approval under the CE Mark in 2019
  • About the company:
    • Founded in 2011 in the U.K., spun out of the University of Aberdeen
    • Raised $4.8 million in Series A funding in 2014
    • One of the principals helped form ApaTech, which was eventually acquired by Baxter International

 

JAV

Julie A. Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.

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