Latest Mako Tech Fleshes Out Stryker's Robotic Joint Replacement Line But Cost Critics Still There

Stryker launched the Mako robotic arm-assisted total knee arthroplasty system at last week's AAOS annual meeting, making the company the first to offer a surgical robotic technology that covers the total knee, partial knee and total hip replacements. Critics, however, say the clinical outcomes do not necessarily justify the costs. Meanwhile, Stryker's orthopedic rivals, Zimmer Biomet and Smith & Nephew, also sought to highlight their own robotic offerings.

xray left knee and show pre-post operation total knee replacement

Uptake of Stryker Corp.'s recently launched Mako system for performing total knee replacements – the third approved application of the robotic arm – is expected to be quick due to the need for technology that can improve clinical outcomes in this procedure. However, the company would have to spend resources generating more clinical data to convince skeptics that the cost of a robotic-assisted system justifies the advantages such a technology could offer.

Stryker officially introduced the Mako total knee system to much fanfare on Mar. 16, at the Annual Meeting of the...

Medtech Insight Podcast

Keep up with the top medtech business and regulatory news.

Medtech Insight brings you interviews and analysis, on the go.

More from Orthopedics

News We’re Watching: New FDA Approvals For Breast Implant, Colon Cancer Test, Imaging Agent; TAP Expansion, AI Standards

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.  

Pilot To Program: FDA Issues Accreditation Scheme For Conformity Assessment Draft Guidances

 

The US FDA has published a trio of draft guidance documents for its Assessment Scheme for Conformity Program, which began as a pilot in September 2020 to capitalize on the role of standards in the regulation of medical devices.

News We’re Watching: Neuralink’s Blindsight Gets FDA Breakthrough Device Tag; FDA Pump Recalls, Guidances; Discure, DeepLook Bolster Coffers

This week, Neuralink announced it received US FDA breakthrough device designation for a device to restore sight; medtechs Discure and DeepLook secured new funding; FDA pump recalls from B. Braun Medical and Fresenius Kabi; Axonics prevails in patent infringement lawsuit with Medtronic; Merit Medical buys Cook Medical for $210m.

Biocomposites Fully Acquires SYNICEM And Subiton Lines, Launches NanoBone In UK

 

UK-based Biocomposites will begin selling in the UK its next-generation osteoinductive bone graft substitute, NanoBone, which came with its acquisition of Artoss GmbH in June 2023. Meanwhile, the company has purchased remaining shares in the manufacturers of SYNICEM and Subiton antibiotic bone cements and preformed antibiotic-loaded spacers.

More from Device Area

Owkin Teams With AstraZeneca To Develop AI-Based Breast Cancer Prescreening Tool

 

Biopharmaceutical giant AstraZeneca has partnered with start-up “unicorn” Owkin to develop an AI-powered tool to prescreen for gBRCA mutations on the basis of morphological features in digitized pathology slides. Built on extensive, high-quality data sourced from the France-based PortrAIt consortium, the AI will help to prioritize patients for further testing, streamlining the diagnostic process, Owkin says.

Route 92 To Drive FreeClimb Neurointervention Sales With Extended Series F Funding

 

An additional $50m brings the neurovascular intervention specialist’s total Series F funding to $82m. Route 92 says it will use the capital to build its sales and support teams and pursue regulatory authorizations around the globe for its FreeClimb portfolio while advancing its SUMMIT MAX clinical trial for the investigational Monopoint Reperfusion System.

TRiCares Initiates EU Pivotal Study For Topaz Tricuspid Valve Replacement

 

TRiCares announced first implantation of the Topaz transfemoral tricuspid heart valve replacement system as part of the company’s EU pivotal study. If all goes to plan, the device will compete with Edwards’ Evoque system. The announcement follows the company’s $50m series D funding raise in July.