Curated for Orthogate.org Members

EXECUTIVE SUMMARY

• Settlement of Patent Litigation with Catalyst OrthoScience: Shoulder Innovations, Inc. resolved all patent litigation concerning its InSet™ ecosystem, protecting core intellectual property across anatomic and reverse shoulder arthroplasty while ensuring uninterrupted surgeon access.
• FDA 510(k) Clearance for ActivaScrew™ Cannulated COM: Bioretec Ltd received 510(k) clearance for its headless bioabsorbable compression screw, providing rigid extremity fixation that resorbs over time and eliminates secondary hardware removal procedures.
• FDA 510(k) Clearance for Knee Soft Tissue Fixation: ArthroTAK LLC expanded indications for its sutureless PEEK fixation platform into the knee for Lateral Extra-articular Tenodesis (LET), cutting operative time and eliminating knot tying during ACL stabilization.
• Primal K-Wire Cleared: Paragon 28, Inc. received FDA 510(k) clearance (K262722) for extremity and small bone fixation.
• OsteoCoil™ GT Active Compression System Cleared: Conventus Flower Orthopedics received FDA 510(k) clearance (K260106) for orthopedic bone screw fixation, osteotomy, and fusion.

DAILY ANNOUNCEMENTS BY CATEGORY

Corporate, M&A & Regulatory

Shoulder Innovations, Inc. — Settlement of Patent Litigation with Catalyst OrthoScience

• Summary: Shoulder Innovations announced a settlement agreement with Catalyst OrthoScience resolving all outstanding patent litigation between the two companies regarding shoulder arthroplasty technologies. While terms remain confidential, the agreement protects core intellectual property across preoperative planning, anatomic and reverse implant designs, and procedural instrumentation.
• Key Details:
  • Device/System Name: InSet™ Shoulder Arthroplasty Ecosystem
  • Status: Patent Litigation Settlement
  • Clinical Significance: Resolves legal uncertainty across shoulder arthroplasty, preserving continuous surgeon access to specialized anatomic and reverse shoulder replacement platforms and instrumentation without supply chain or IP disruption.
• Original Source: OrthoSpineNews

Trauma & Extremities

Bioretec Ltd — FDA 510(k) Clearance for ActivaScrew™ Cannulated COM Bioabsorbable Compression Screw

• Summary: Bioretec received FDA 510(k) clearance for its ActivaScrew™ Cannulated COM bioabsorbable compression screw, expanding its PLGA-based fixation portfolio in the United States. The headless, cannulated design sits flush with the cortex to eliminate soft tissue irritation across upper and lower extremity osteotomies, arthrodeses, and fracture fixation.
• Key Details:
  • Device/System Name: ActivaScrew™ Cannulated COM
  • Status: FDA 510(k) Cleared (Commercial Launch)
  • Clinical Significance: Provides rigid bioabsorbable compression without requiring secondary hardware removal surgery, minimizing tendon irritation and hardware prominence in delicate extremity and foot/ankle procedures.
• Original Source: OrthoSpineNews

Joint Reconstruction & Sports Medicine

ArthroTAK LLC — FDA 510(k) Clearance for Expanded Soft Tissue Fixation Indications into the Knee

• Summary: ArthroTAK received FDA 510(k) clearance expanding its sutureless PEEK fixation technology beyond shoulder biceps tenodesis into knee indications, specifically Lateral Extra-articular Tenodesis (LET). The system enables rigid soft-tissue-to-bone fixation in under 60 seconds using a “Drive. Deploy. Done.” technique that eliminates intraoperative suture management.
• Key Details:
  • Device/System Name: ArthroTAK Sutureless Tendon Fixation Platform
  • Status: FDA 510(k) Cleared (Expanded Indications)
  • Clinical Significance: Streamlines procedural efficiency during Lateral Extra-articular Tenodesis (LET) performed concurrently with ACL reconstruction, reducing operative time and eliminating knot tying while reinforcing anterolateral rotational knee stability.
• Original Source: BONEZONE

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.