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FDA 510(k) Insights: March Clearance Highlights

Each month, ORTHOWORLD examines updates to FDA’s orthopaedic-related 510(k) database and calls out certain products—a company’s first orthopaedic 510(k), for example, or first clearance in a market segment that is new to the company, clearance for a type of device not formerly marketed by a company, etc.

Of 51 products gaining clearance under FDA’s Orthopedic Panel in March, we highlight the following four.

AJU Pharm
Seongnam, Korea |
Joinix Cannular System, K162070

  • Company’s first 510(k) 
  • Joinix, comprising single-use cannula and trocar, facilitates entry into the glenoid cavity during arthroscopic surgery. 
  • Founded in 1953 to provide treatments for tuberculosis patients, AJU now offers pharmaceuticals and medical devices (e.g. suture anchors for rotator cuff repair, stem cell therapies, etc.).


Quebec City, Quebec, Canada |
Unicompartmental Knee, K163700

  • Company’s first 510(k) 
  • Bodycad’s process is based on proprietary 3D rendering of medical images of the patient’s anatomy. Their approach to joint reconstruction, described as a personalized restoration, is delivered as a “procedure in a box” with the patient-specific implant and instruments. 
  • Pipeline includes applications in total knee, total hip and shoulder

Logan, Utah, USA |
Flex-Thread Clavicle Pin, K163488

  • Company’s first 510(k) 
  • IntraFuse, a portfolio company of incubator Surgical Frontiers, will focus on less invasive intramedullary fracture fixation of the clavicle, radius, ulna and fibula. 
  • Specifically, the Flex-Thread pin comprises a flexible threaded distal tip to engage the curved medial portion of the clavicle, and a proximal cross screw to support stability and fixation to the lateral portion of the bone. The device is constructed of stainless steel and PEEK. 
  • Others in the incubator’s portfolio include First Ray (focused on less invasive surgical techniques in the foot), Kator (arthroscopic rotator cuff repair, Achilles tendon repair and ligament stabilization) and Mortise Medical (ligament reinforcement and repair in cases of ankle sprain and fracture).

MicroPort Orthopedics
Arlington, Tennessee, USA |
EVOLUTION Revision Tibial System, K162026

  • First 510(k) in a year for MicroPort; clearance for a tibial revision option in the EVOLUTION line 
  • In early 2Q17, MicroPort launched the cemented EVOLUTION Revision Tibial System and the cementless EVOLUTION BioFoam tibia together (the latter received clearance in 4Q15). 
  • The revision tibia is based on the company’s Medial-Pivot Knee design, and offers intra-operative flexibility based on a patient’s anatomy, variable quality of bone stock, etc. 
  • The BioFoam tibia completes the EVOLUTION Medial-Pivot Cementless portfolio, which also includes a porous femoral component. Cementless fixation appeals to the younger patient population.