Curated for Orthogate.org Members

EXECUTIVE SUMMARY

• AMA CPT Editorial Panel Votes to Establish a Category I CPT Code for Posterior Vertebral Column Arthroplasty: Reported by Orthopedics This Week, Premia Spine announced that the American Medical Association's (AMA) CPT® Editorial Panel voted to establish a Category I CPT® Code for Posterior Vertebral Column Arthroplasty effective January 1, 2028, establishing the TOPS™ System and lumbar facet arthroplasty as a recognized standard-of-care motion-preserving modality alongside disc arthroplasty for lumbar spinal stenosis and degenerative spondylolisthesis.
• Tenon Medical Announces Full Commercial Launch of the SImmetry®+ SI Joint Fusion 3D Printed Lateral Screw Following Successful Alpha Launch: Reported by Orthopedics This Week, Tenon Medical announced the full commercial launch of its 3D-printed titanium lateral screw within the SImmetry®+ SI Joint Fusion System following a successful clinical Alpha launch, combining minimally invasive lateral decortication, autograft delivery, and structural sacroiliac fixation to optimize biological arthrodesis.
• Applied Biologics Publishes New Translational Research Demonstrating Ligament Regeneration with XWRAP-Based Biologic Augmentation: Reported by OrthoSpineNews, Applied Biologics published translational research demonstrating that XWRAP® human amniotic membrane combined with amniotic-fluid biologics promoted native-like collagen fibril regeneration with up to a 50% increase in mean fibril diameter in a preclinical ligament defect model, supporting biologic augmentation in complex sports medicine and ligament reconstruction.
• Medacta M-Vizion Femoral Revision System Extension Cleared: Medacta International S.A. secured FDA 510(k) clearance (K260173) for the M-Vizion Femoral Revision System Extension, indicated for modular femoral revision hip arthroplasty.
• Treace Medical Concepts TMC Implant Fixation System Cleared: Treace Medical Concepts, Inc. received FDA 510(k) clearance (K262963) for the TMC Implant Fixation System, indicated for hallux valgus correction and midfoot arthrodesis fixation.

DAILY ANNOUNCEMENTS BY CATEGORY

Spine & Orthobiologics

Premia Spine, Inc. — AMA CPT Editorial Panel Votes to Establish a Category I CPT Code for Posterior Vertebral Column Arthroplasty

• Summary: Premia Spine announced that the American Medical Association's (AMA) CPT® Editorial Panel has voted to establish a Category I CPT® Code for Posterior Vertebral Column Arthroplasty, effective January 1, 2028. This landmark reimbursement decision establishes lumbar facet arthroplasty as a recognized standard-of-care motion-preserving modality alongside disc arthroplasty for patients with lumbar spinal stenosis and degenerative spondylolisthesis.
• Key Details:
  • Device/System Name: TOPS™ System (Posterior Vertebral Column Arthroplasty / Facet Arthroplasty)
  • Status: Category I CPT® Code Approved (Effective January 1, 2028)
  • Clinical Significance: Establishes permanent reimbursement pathway for lumbar motion preservation; backed by pivotal FDA trial evidence demonstrating the TOPS™ System achieved a 77% overall clinical success rate compared to 24% for TLIF fusion at two years post-op, while preserving segmental biomechanical motion and significantly reducing reoperation rates.
• Original Source: Orthopedics This Week

Spine & Orthobiologics

Tenon Medical, Inc. — Tenon Medical Announces Full Commercial Launch of the SImmetry+ SI Joint Fusion 3D Printed Lateral Screw Following Successful Alpha Launch

• Summary: Tenon Medical announced the full commercial launch of its newly engineered 3D-printed titanium lateral screw within the SImmetry®+ SI Joint Fusion System following a completed clinical Alpha launch that generated $1.2M in incremental revenue. SImmetry®+ is a minimally invasive lateral and posterior oblique-access sacroiliac joint fusion system integrating joint decortication, autograft delivery, and structural fixation.
• Key Details:
  • Device/System Name: SImmetry®+ SI Joint Fusion System & 3D-Printed Titanium Lateral Screw
  • Status: Full Commercial Launch (Following Alpha Launch Series)
  • Clinical Significance: Provides active joint decortication prior to implant seating to optimize biological arthrodesis across the sacroiliac interface; features expanded titanium implant sizing to accommodate challenging sacro-pelvic anatomies with reduced operative morbidity.
• Original Source: Orthopedics This Week

Spine & Orthobiologics

Applied Biologics — Applied Biologics Publishes New Translational Research Demonstrating Ligament Regeneration with XWRAP-Based Biologic Augmentation

• Summary: Applied Biologics announced publication of translational research evaluating XWRAP® human amniotic membrane in combination with an amniotic-fluid-derived biologic in a preclinical rabbit medial collateral ligament (MCL) gap-defect model. Biologic augmentation demonstrated a statistically significant shift away from scar-mediated repair toward authentic native-like collagen fibril architecture.
• Key Details:
  • Device/System Name: XWRAP® Human Amniotic Membrane & Amniotic-Fluid Biologic Matrix
  • Status: Peer-Reviewed Translational Research Publication
  • Clinical Significance: Demonstrated a 42% to 50% increase in mean collagen fibril diameter (p<0.0001) over untreated controls, recovering 90% of native uninjured fibril diameter by six weeks with a bimodal diameter distribution, validating biologic augmentation for complex sports medicine and ligamentous reconstructions.
• Original Source: OrthoSpineNews

RECENTLY INDEXED FDA 510(k) & PMA CLEARANCES — ORTHOPAEDIC

Note: The openFDA database typically indexes clearances 2–4 weeks after the official decision date. Dates shown reflect the FDA decision date, not the indexing date.