FDA 510(k) Recap: Line Extensions and Small Companies

Of the 49 products cleared by FDA’s orthopedic panel in April, we’ve chosen five for a close look this month. These include line extensions or product updates in joint replacement from familiar companies Arthrex, Medacta and OrthAlign, and clearances for trauma products from two lesser-known companies, Akros Medical and Subchondral Solutions.

Joint Replacement

Arthrex | ArthrexVIP Web Portal, K193523
Submitted December 2019
Primary predicate: K162697: ArthrexVIP Web Portal (Main image)

• Image processing system and preoperative software for simulating/evaluating implant placement and surgical treatment options
• The Web Portal is a software interface that transfers imaging information from a CT scanner, and can display and edit implant placement and surgical treatment options that were generated by OrthoVis Desktop software
• System is intended for use with the Arthrex Glenoid Intelligent Reusable Instrument System and the Arthrex OrthoVis Preoperative Plan for use with the Arthrex Univers II and Arthrex Univers Apex, Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers and Modular Glenoid System (MGS) Baseplate components
• Changes from the predicate device include additions of:
  • The Modular Glenoid System baseplate to the indicated glenoid implant lines
  •  A backside seating feature
  • Univers Revers Modular Glenoid System implant models
  • Univers Revers Universal Glenoid implant models
  • Glenosphere and inlay implant models compatible with MGS and UG
  • Glenoid bone preparation instrument models for visualization
  • Univers Revers screw trajectory models for visualization

Medacta | M-Vizion Femoral Revision System Extension, K191816
Submitted July 2019
Primary predicate: Medacta M-Vizion Femoral Revision System, K170690

• Modular stem designed for cementless use in total or partial hip arthroplasty in primary or revision surgery
• Subject clearance expands the M-Vizion system with additional sizes, lengths and diameters, specifically, new Proximal Body and Distal Stem diameters and lengths (bigger and longer)

OrthAlign | OrthAlign Plus System, K200642
Submitted March 2020
Primary predicate: OrthAlign Plus System, K171780

• Non-invasive, computer assisted surgical navigation for use in knee and hip arthroplasty procedures
• Configured to detect, measure, and display angular and positional measurement changes in a triaxial format
• Subject clearance addresses updates to provide sterile, single use fixation pins and femoral registration markers for use in total hip arthroplasty; other features and principals of operation remain the same

Trauma

Akros Medical | Suture Anchor LisFranc Repair Kit, K200361
Submitted February 2020
Primary predicate: Arthrex Mini TightRope, K061925

• Multiple-anchor orthopedic fixation device system offered in stainless steel and titanium versions
• An adjunct in repair of unstable joints to provide fixation between the bones of the midfoot during the healing process following a Lisfranc injury
• Second FDA-cleared product for the company, following the FibuLink syndesmosis repair system, first cleared in 2017
• Company founded in 2014, based in Durham, North Carolina; CEO has engineering experience at DJO, Integra LifeSciences, Tarsus Medical

Subchondral Solutions | S4 Screw System, K191995
Submitted July 2019
Primary predicate: Subchondral Solutions S4 Screw System, K162171

• A collection of titanium alloy cannulated, headless screws having fenestrations on the head and within the thread pitch, indicated for fixation of fracture, fusion and osteotomies
• Device initially cleared in 2017
• Subject clearance addresses additional sizes, as well as the optional addition of hydroxyapatite (HA) coating
• Additional sizes enable repair of larger bones, as appropriate for the size of the device, and the HA coating is intended to improve bone growth
• Founded 2014 and based in Los Gatos, California, the company has also developed the S-Core Core Preserving Osteochondral Reconstruction System, a platform technology that treats osteochondral fracture and joint damage; the implant preserves bone, promotes bone growth and provides biomechanical stabilization while providing a secure anchor for a scaffolding; slated for availability in 2020

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