Onkos Surgical Archives - Medical Design Sourcing

Onkos wins FDA clearance for 3D-printed pelvic reconstruction system

Onkos Surgical announced today that the FDA has cleared its My3D personalized pelvic reconstruction system.

My3D expands Onkos Surgical’s portfolio to include systems to treat pelvic conditions.

The Parsippany, New Jeresey–based company said My3D includes 3D-printed implants, instruments and models. There is also an advanced planning service to treat deformity, trauma, disease and revisions. There are patient-specific implants for both acetabular reconstruction and advanced reconstruction that span multiple regions of the pelvis.

“Patients with these conditions of the pelvis have many clinical challenges. Historically, our implant options are mass-produced and may not be best suited for the individuality that each patient requires. With this platform, Onkos has developed a process that allows me to virtually plan the surgery in advance and delivers a patient-specific implant and instruments in a matter of weeks. It changes the way I can treat…

Onkos Surgical raises $26.5M

Surgical oncology device maker Onkos Surgical today filed an amendment to an SEC Form D confirming the sale of $26.5 million in equity.

The equity offering had its first sale on Aug. 31, 2021 and today reached $26,500,001. That leaves no amount remaining to be sold.

According to the amended SEC Form D, 16 investors participated in the fundraising, which had a minimum investment for outside investors of $0.

Onkos said in the filing that the fundraising was not made in connection with a business combination transaction, such as a merger, acquisition or exchange offer.

In April 2020, Onkos confirmed the sale of nearly $7.6 million in equity. The Parsippany, New Jersey-based company’s total offering amount in that instance was $12 million. That financing was intended to add the $12 million total to a $17.6 million Series B funding round that Onkos closed in 2017.

The company develops a range of devices, including the BioGrip 3D-printed im…

Onkos Surgical to acquire Stryker’s Juvenile Tumour System

Onkos Surgical announced today that it agreed to acquire the Juvenile Tumour System (JTS) from Stryker (NYSE:SYK).

Parsippany, New Jersey-based Onkos entered into a definitive agreement with the orthopedic technology giant over the system designed to enable limb stabilization and growth in pediatric patients affected by bone cancers, severe arthropathy, severe trauma, revisions, oncology and malignant diseases.

Onkos, which specializes in solutions for musculoskeletal oncology and other complex orthopedic conditions, said in a news release that the JTS allows for the non-invasive lengthening of the implant post-surgery over time in a clinical setting.

The design of JTS eliminates the need for multiple lengthening surgeries, anesthesia or sedation, therefore helping to reduce the risk of complications and cost associated with limb reconstruction surgery.

“This is a significant day for Onkos Surgical and the musculoskeletal oncology community,…

Onkos Surgical wins FDA clearance for BioGrip 3D-printed implant

Onkos Surgical today announced that it received FDA 510(k) clearance for its BioGrip 3D-printed implant technology.

Parsippany, N.J.-based company designed BioGrip to address the clinical challenge of aseptic loosening in musculoskeletal oncology and complex orthopedic limb salvage surgery. It helps provide bone ingrowth at the bone-implant interface.

Get the full story on our sister site, Medical Design & Outsourcing.

Onkos Surgical wins FDA clearance for BioGrip 3D-printed implant

Onkos Surgical today announced that it received FDA 510(k) clearance for its BioGrip 3D-printed implant technology.

Parsippany, N.J.-based company designed BioGrip to address the clinical challenge of aseptic loosening in musculoskeletal oncology and complex orthopedic limb salvage surgery. It helps provide bone ingrowth at the bone-implant interface.

The 3D-printed porous structure, nano HA treated design is one of two interchangeable collar designs, according to the company. The FDA clearance also includes an oval-shaped collar design for greater contact in distal femoral replacements where subsidence is a common challenge.

“This is a historic day for Onkos Surgical. When we started the company, we set out to deliver innovation that would directly address the long-established clinical challenges of limb salvage surgery – soft-tissue attachment, implant loosening, and infection. In the past six months, we have made significant progress by la…