First 510(k)s for Companies in Joint Replacement, Spine, Trauma, SportsMed and Obio

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This month’s recap rounds up many companies new on our radar, helmed by people who’ve known the industry for a long time. Geographically, they span the U.S., Canada, France and Turkey. All are first 510(k)s, except for IlluminOss, which is included to highlight expanding indications gained for its Photodynamic Bone Stabilization System.

Joint Replacement

Unik Orthopedics | UNIKO PointCloud Knee Instruments, K193312

  • Submitted November 2019, granted August 2020
  • Primary predicates: Materialise Zimmer Patient Specific Instrument System 6.0, K140027 and Stryker ShapeMatch Cutting Guide, K122053
  • UNIKO PointCloud Instruments use the surgical plan that is output from the Vault System surgical planning software (cleared under K124051) to position total knee replacement components intra-operatively, and to guide the marking of bone before cutting
  • UNIKO PointCloud Instruments are compatible with the femoral and tibial components of the DJO EMPWR 3D Knee
  • About the company:
    • Established 2019, based in San Jose, California
    • Leadership brings experience from OtisMed, Somersault Orthopedics


Expanding Innovations | X-Pac Expandable Lumbar Cage System, K201145

  • Submitted April 2020, granted September 2020
  • Primary predicates: SpineView X-Pac Expandable Lumbar Cage System, K152539 and K160856
  • About the company:
    • Established in 2018, based in Mountain View, California
    • Focused on developing and commercializing a fully expandable cage portfolio
    • Leadership has over 65 years of combined corporate and sales spine experience; brings experience from ArthroCare, DePuy Spine, Medtronic, SpineView

PrinterPrezz | GAIA Lumbar Interbody Fusion Device (LIFD) Family, K201939

  • Submitted July 2020, granted October 2020
  • Primary predicate: HD LifeSciences HD Lumbar Interbody System, K170676
  • The GAIA LIFD family comprises the ASTRAEUS ALIF, the PROMETHEUS PLIF and the THEMIS TPLIF
  • Manufactured in titanium (Ti6Al4V-ELI) using Laser Powder Bed Fusion technology
  • Products represent PrinterPrezz’s cumulative learnings in medical device design, additive manufacturing processes, non-active implantable medical device (testing, cleaning, packaging & sterilization and quality management)
  • About the company:
    • Established in 2018, based in Fremont, California
    • Provides OEM customers with access to a variety of 3D printing machines, 3D manipulation software and 3D scanners as well as advanced manufacturing processes and surgeon education programs

S.M.A.I.O. | KHEIRON Spinal Fixation System, K201659

  • Submitted June 2020, granted October 2020
  • Primary predicate: Medtronic Sofamor Danek COLORADO 2 Spinal System, K020247
  • Posterior thoraco-lumbar fixation system offering a full range of implants to adress the main pathologies of the spine
  • Received CE Mark approval in 2019; over 500 procedures performed to date
  • About the company:
    • Established in 2009, based in Lyon, France
    • Name stands for Software, Machines and Adaptive Implants in Orthopedics
    • Has also developed the CE-Marked KEOPS data management and surgical planning platform and Balance Analyzer 3D measuring and planning software
    • Leadership brings experience from Arthro-Dif, ConMed, Marle, Medicrea, Spineway, Stryker, Tornier, Wright Medical

Sports Medicine

Acuitive Technologies | CITREGEN Tendon Interference Screw and CITRELOCK, K200725

  • Submitted March 2020, granted October 2020
  • CITREGEN material is a new-generation FDA-cleared thermoset bioresorbable synthetic polymer
  • CITREGEN is a synthetic biomaterial 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 extremities
  • 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


IlluminOss expands indications in 2020
In 2018, IlluminOss Medical received FDA De Novo clearance for the Photodynamic Bone Stabilization System to treat pathological fractures of the humerus, radius and ulna. Within 2020, the company has rapidly expanded indications for the system, including these additional FDA 510(k) clearances:

  • K200295, Pelvic, clavicle and small bones of the hands and feet: metacarpals, metatarsals and phalanges; submitted February 2020, granted June 2020
  • K201961, Fractures of the fibula; submitted July 2020, granted August 2020
  • K202887, Femur and tibia fractures as a supplement to FDA-cleared fracture fixation systems; submitted September 2020, granted October 2020

MY01 | MY01 Continuous Compartmental Pressure Monitor, K193321

  • Submitted December 2019, granted July 2020
  • Primary predicate: Twin Star Medical Extremity Compartment Monitor and Fluid Collection System (ECM-III), K131966
  • Intended for real-time, continuous measurement of compartmental pressures, which can be used to aid in the diagnosis of compartment syndrome
  • Measurements from the device are displayed at the bedside and wirelessly to the care team through the MY01 App; which enables storage of data on the Cloud for retrieval after the episode of care
  • About the company:
    • Established 2015, based in Montreal, Quebec, Canada
    • Spun out of a Master’s project at McGill University
    • Leadership brings experience from Johnson & Johnson DePuy, Stryker, Synthes, Zimmer Biomet


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

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

Julie A. Vetalice is ORTHOWORLD’s Editorial Assistant.