Onkos Surgical FDA Clearance Adds Options to Limb Salvage System

Orthopedic patients with bone cancer have special needs. Bone healing is compromised, and device loosening is a risk.

On June 22, 2021, Onkos Surgical announced FDA 510(k) clearance for its modular collar portfolio featuring the company’s BioGrip^® 3D-printed implant technology. The patented design is part of the company’s ELEOS Limb Salvage System. The system, according to the company, was created to “help address the clinical challenge of aseptic loosening (also known as implant loosening) in musculoskeletal oncology and complex orthopaedic limb salvage surgery.”

Modular Collars

The current clearance is a line extension to the company’s previously cleared device. The difference is the provision of modular collars to match patient anatomy. Specifically, the stems have been modified to accept porous or solid modular collars.

In the previous clearance, the company stated the BioGrip implant incorporates an additive porous surface (replacing titanium plasma) and additional suture holes are incorporated “to better facilitate approximation of soft tissue and support bony apposition.” The porous collars are manufactured with the option to be treated with a nano HA (hydroxyapatite) surface treatment. The implant incorporates a hybrid stem and a modular collar with or without HA.

Shervin Oskouei, M.D., Division Director of Orthopedic Oncology at Emory University and Chief of Orthopedic Surgery at Emory University Hospital Midtown, said research has shown that designs treated with hydroxyapatite “provide greater surface area for bone ingrowth and may result in lower rates of implant loosening. Having this technology available at the bone-implant junction is critical to supporting a reconstruction that may lead to improved implant longevity for these complex procedures.”

System Components

The system’s components are femoral head, proximal femur, mid-section, stem, distal hinge femur, tibial hinge assembly, axial pin, tibial poly spacer, tibial sleeve, male-male mid-section, resurfacing hinge femur, and proximal tibia, optional components include modular collars, patella, stem extensions, tibial wedges and augments.

According to FDA clearance documents, the system’s components are used in the reconstruction of the lower limb. The reconstruction applications are for the proximal femur, distal femur, total femur, proximal tibia, and hinged knee.

The clearance also includes an oval shaped collar design to provide greater contact in distal femoral replacements.

Indications for Use

Hip components are indicated for use in total hip arthroplasty. Knee components are indicated for cemented use in knee arthroplasty. Both components are indicated for reduction or relief of pain and/or improved hip and knee functions in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia;
2. Inflammatory degenerative joint disease such as rheumatoid arthritis;
3. Correction of functional deformity
4. Revision procedures where other treatments or devices have failed; and,
5. Treatment of fractures that are unmanageable using other techniques.

Both component of the system are also indicated for procedures where radical resection and replacement of the proximal, distal and/or total femur, and, where radical resection and replacement of the proximal tibia is required with the following conditions:

1. Patients suffering from severe arthropathy of the hip/knee that does not respond to any conservative therapy or better alternative surgical treatment;
2. Surgical intervention for severe trauma, revision hip/knee arthroplasties, and/or Oncology indications.
3. Metastatic diseases.

The Parsippany, New Jersey-based company was founded in 2015 and is privately held.