Stryker Granted FDA 510(k) Clearance for InSpace Balloon Spacer

The InSpace implant is an arthroscopic treatment for massive irreparable rotator cuff tears that provides sustained patient improvements.

Hyalex Gains Breakthrough Device Designation for HYALEX Cartilage System

HYALEX Cartilage is intended to repair defects and restore function for patients with loss of knee articular cartilage and bone requiring surgery.

Via Surgical Gains FDA 510(k) for TissueTak Tendon Anchor

This is the first closed-loop suture fixation for soft tissue to soft tissue repair of certain types of injuries, designed for less-invasive procedures.

Biorez Granted FDA 510(k) Clearance of BioBrace Soft Tissue Scaffold

The implant is the first biocomposite soft tissue scaffold designed to reinforce tendon and ligament repairs and fully resorb.

Sparta Biomedical Receives FDA Breakthrough Device Designation for SBM-01 Biomimetic Implant

The SBM-01 Biomimetic Implant is intended to replace damaged knee cartilage in single or multiple chondral or osteochondral defects.

Acuitive Technologies Gains FDA Clearance for CITRESPLINE and CITRELOCK Ligament Reconstruction

CITRESPLINE/CITRELOCK is intended to engage tendons and ligaments within a bone tunnel while preserving soft tissue integrity during insertion.

Acuitive Technologies Gains FDA 510(k) Clearance for CITREFIX Knotless Suture Anchor

The CITREFIX Knotless Suture Anchor features CITREGEN material technology, a new generation bioresorbable synthetic polymer.

Geistlich Pharma Granted FDA Breakthrough Device Designation for Chondro-Gide Articular Cartilage Cover

Chondro-Gide articular cartilage cover is a collagen membrane that is used in a single-step cartilage repair technique.

Miach Orthopaedics Granted FDA De Novo Approval for Treatment of ACL Tears

The Bridge-Enhanced ACL Repair (BEAR®) Implant is the first medical technology to clinically demonstrate or restoration of a torn ACL.

Embody Gains FDA 510(k) Clearance of TAPESTRY Biointegrative Implant for Tendon and Ligament Repair

TAPESTRY is a bioengineered collagen-based implant with a proprietary micro-architecture specifically designed for tendon and ligament repair.

Regulatory | Clinical

Articles

Stryker Granted FDA 510(k) Clearance for InSpace Balloon Spacer

Stryker Granted FDA 510(k) Clearance for InSpace Balloon Spacer

Hyalex Gains Breakthrough Device Designation for HYALEX Cartilage System

Hyalex Gains Breakthrough Device Designation for HYALEX Cartilage System

Via Surgical Gains FDA 510(k) for TissueTak Tendon Anchor

Via Surgical Gains FDA 510(k) for TissueTak Tendon Anchor

Biorez Granted FDA 510(k) Clearance of BioBrace Soft Tissue Scaffold

Biorez Granted FDA 510(k) Clearance of BioBrace Soft Tissue Scaffold

Sparta Biomedical Receives FDA Breakthrough Device Designation for SBM-01 Biomimetic ...

Sparta Biomedical Receives FDA Breakthrough Device Designation for SBM-01 Biomimetic Implant

Acuitive Technologies Gains FDA Clearance for CITRESPLINE and CITRELOCK Ligament ...

Acuitive Technologies Gains FDA Clearance for CITRESPLINE and CITRELOCK Ligament Reconstruction

Acuitive Technologies Gains FDA 510(k) Clearance for CITREFIX Knotless Suture ...

Acuitive Technologies Gains FDA 510(k) Clearance for CITREFIX Knotless Suture Anchor

Geistlich Pharma Granted FDA Breakthrough Device Designation for Chondro-Gide Articular ...

Geistlich Pharma Granted FDA Breakthrough Device Designation for Chondro-Gide Articular Cartilage Cover

Miach Orthopaedics Granted FDA De Novo Approval for Treatment of ...

Miach Orthopaedics Granted FDA De Novo Approval for Treatment of ACL Tears

Embody Gains FDA 510(k) Clearance of TAPESTRY Biointegrative Implant for ...

Embody Gains FDA 510(k) Clearance of TAPESTRY Biointegrative Implant for Tendon and Ligament Repair

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