Prosidyan Gains CE Mark for FIBERGRAFT Bone Grafts

FIBERGRAFT BG Putty, FIBERGRAFT BG Putty GPS and FIBERGRAFT BG Morsels are intended for use in the lumbar and anterior cervical spine.

Cerapedics Gains Breakthrough Device Designation for P-15L Bone Graft for the Treatment of Degenerative Disc Disease

P-15L Bone Graft is part of an IDE study vs. autologous bone graft in TLIF surgery.

Avitus Orthopaedics Gains FDA Clearance for Expanded Indications of Avitus Bone Harvester

The Avitus Bone Harvester is now indicated for debridement and capture of diseased cancellous bone such as osteomyelitis and tumors.

Seikagaku Granted Marketing Approval for JOYCLU Joint Function Improvement Injection

JOYCLU, a combination of hyaluronic acid and an anti-inflammatory drug, is approved for manufacture and marketing in Japan.

FDA Clinical Hold Removed for Histogen Trial in Knee Regeneration

Histogen can proceed with a Phase I/II clinical trial examining human extracellular matrix plus microfracture to regenerate hyaline cartilage.

TissueTech to Commence Study on Facet Joint Osteoarthritis Pain

The study is investigating Cryopreserved Amniotic Membrane and Cryopreserved Umbilical Cord for pain relief and functional improvement.

Locate Bio’s Chondro3 Graft Granted FDA Breakthrough Device Designation

The biomimetic graft for osteochondral lesions is the company's second Breakthrough Device designation granted in 2021.

FDA Clinical Hold for Histogen Trial in Knee Regeneration

FDA verbally notified the company of additional questions in the application for the planned Phase I/II trial of HST-003 combined with microfracture.

Organogenesis Gains Special FDA Designation for ReNu Knee OA Therapy

ReNu comprises amniotic fluid cells and micronized amniotic membrane, and contains cellular, growth factor and extracellular matrix components.

CognitOss Granted FDA Breakthrough Device Designation

Locate Bio developed CognitOss resorbable antibiotic-loaded bone graft to treat osteomyelitis.

Regulatory

Articles

Prosidyan Gains CE Mark for FIBERGRAFT Bone Grafts

Prosidyan Gains CE Mark for FIBERGRAFT Bone Grafts

Cerapedics Gains Breakthrough Device Designation for P-15L Bone Graft for ...

Cerapedics Gains Breakthrough Device Designation for P-15L Bone Graft for the Treatment of Degenerative Disc Disease

Avitus Orthopaedics Gains FDA Clearance for Expanded Indications of Avitus ...

Avitus Orthopaedics Gains FDA Clearance for Expanded Indications of Avitus Bone Harvester

Seikagaku Granted Marketing Approval for JOYCLU Joint Function Improvement Injection

Seikagaku Granted Marketing Approval for JOYCLU Joint Function Improvement Injection

FDA Clinical Hold Removed for Histogen Trial in Knee Regeneration

FDA Clinical Hold Removed for Histogen Trial in Knee Regeneration

TissueTech to Commence Study on Facet Joint Osteoarthritis Pain

TissueTech to Commence Study on Facet Joint Osteoarthritis Pain

Locate Bio’s Chondro3 Graft Granted FDA Breakthrough Device Designation

Locate Bio’s Chondro3 Graft Granted FDA Breakthrough Device Designation

FDA Clinical Hold for Histogen Trial in Knee Regeneration

FDA Clinical Hold for Histogen Trial in Knee Regeneration

Organogenesis Gains Special FDA Designation for ReNu Knee OA Therapy

Organogenesis Gains Special FDA Designation for ReNu Knee OA Therapy

CognitOss Granted FDA Breakthrough Device Designation

CognitOss Granted FDA Breakthrough Device Designation

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