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August 5, 2026

Your Weekly Update on the Orthopedic Device Industry

Regulatory Considerations for Additively Manufactured Implants

Additive manufacturing has raised the FDA’s expectations for process understanding, validation, and lifecycle control.
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Today's Top Headlines

OEM News

FDA Grants De Novo Classification to Smith+Nephew’s TESSA Spatial Surgery System

The first indication for use is femoral anterior cruciate ligament knee reconstruction.

OEM News

3D Systems Supports First FDA-Cleared Point-of-Care Implant

3D MAC's patient-specific Titanium Cranial Plate will be used to treat U.S. active duty personnel and war fighters suffering from traumatic head injuries.

OEM News

VB Spine Wins Expanded FDA Nods for Vitoss Bone Graft, Interbodies

Vitoss can now be used in the intervertebral disc space and with bone void fillers cleared for use in intervertebral body procedures.

OEM News

Advita Ortho Initiates Campaign to Reinforce its Commitment to Surgeon-Centered Innovation

The campaign's focus is Advita GPS, the company’s surgeon-controlled real-time guidance platform.

OEM News

Carlsmed’s aprevo Lumbar Procedures Earn CMS Reimbursement

All inpatient aprevo lumbar fusion procedures are reimbursable under one of three new MS-DRG codes.

OEM News

SpineGuard, Omnia Medical Obtain New U.S. Patent for Sacroiliac Joint Fusion Tech

The technology was co-developed in partnership by both companies.

Online Exclusives

Tariffs and Trade Pressures in Orthopedics: Rewiring Strategies for Resilience

The industry is trending toward enhancing operational flexibility and minimizing exposure to tariff-related cost pressures and supply chain disruptions.