Anika’s Tactoset Injectable Bone Substitute Now FDA-Cleared for Hardware Augmentation

The injectable bone substitute is now FDA 510(k) cleared for augmenting suture anchor fixation.

Kuros Biosciences Gains FDA 510(k) Clearance for MagnetOs Easypack Putty

The clearance follows existing clearances by the FDA for the use of MagnetOs Granules and MagnetOs Putty in the spine.

Royal Biologics Gains FDA 510(k) for Maxx Concentration System

Maxx-PRP is a next-gen device to concentrate autologous whole blood for the safe and rapid preparation of platelet-rich plasma.

Biocomposites Gains Approval for STIMULAN to Treat Bacterial Infection

STIMULAN when mixed with antibiotics is the only calcium matrix approved for treating bacterial infection in soft tissue surrounding bone.

Orthobiologics Strategy: FDA Issues New Warning about Sales of Unapproved Products

FDA doubled down on its enforcement commitment for Human Cell and Tissue Products after its enforcement discretion ended in May.

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Breakthrough Designation for BONESUPPORT CERAMENT G for Trauma

CERAMENT G is classified as a breakthrough device for the indication osteomyelitis since March 2020.

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.

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Anika’s Tactoset Injectable Bone Substitute Now FDA-Cleared for Hardware Augmentation

Anika’s Tactoset Injectable Bone Substitute Now FDA-Cleared for Hardware Augmentation

Kuros Biosciences Gains FDA 510(k) Clearance for MagnetOs Easypack Putty

Kuros Biosciences Gains FDA 510(k) Clearance for MagnetOs Easypack Putty

Royal Biologics Gains FDA 510(k) for Maxx Concentration System

Royal Biologics Gains FDA 510(k) for Maxx Concentration System

Biocomposites Gains Approval for STIMULAN to Treat Bacterial Infection

Biocomposites Gains Approval for STIMULAN to Treat Bacterial Infection

Orthobiologics Strategy: FDA Issues New Warning about Sales of Unapproved ...

Orthobiologics Strategy: FDA Issues New Warning about Sales of Unapproved Products

Member-Only Content

Breakthrough Designation for BONESUPPORT CERAMENT G for Trauma

Breakthrough Designation for BONESUPPORT CERAMENT G for Trauma

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

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