Bonalive® putty is a highly moldable, easy-to-apply bone regeneration technology that naturally stimulates bone formation.

Bonalive® putty is an optimized bone graft substitute for orthopedic, trauma and spine surgery. The putty can be delivered directly to the bone defect without mixing or preparation. 

A bioactive, osteoconductive and osteostimulative* synthetic bone cavity filler, the putty is delivered as a sterile ready-to-use paste, requiring no mixing, moistening or other preparation. It consists of S53P4 bioactive glass in addition to a synthetic binder, i.e. a blend of polyethylene glycols (PEGs) and glycerol.

The putty’s radiodense quality enables post-operative evaluation, allowing surgeons to follow the healing of their patients. Unlike the granules, Bonalive® putty does not inhibit bacterial growth.

Intended use
Bonalive® putty is intended for use as a synthetic bone graft substitute for reconstruction and regeneration of bone.

Indications for use
Bonalive® putty is indicated for filling, reconstruction, and/or fusion of bone voids and gaps of traumatic, pathological or surgical origin when autologous solutions are not applicable or sufficient. These bone defects of the skeletal system may be derived in orthopedic surgery, trauma surgery, neurosurgery, and cranio-maxillofacial surgery. Bonalive putty is indicated for use in spine surgery, in benign bone tumor surgery and in the treatment of osteomyelitis when pathological tissue has been surgically removed.

Intended user
Intended for use only by medically qualified professionals. The user must be familiar with bone grafting and fixation techniques.

*non-osteoinductive

Quick user guide for Bonalive® putty

Summary of Safety and Clinical Performance (SSCP) for Bonalive® putty products - for healthcare professionals

Contraindications

Bonalive® putty should not be applied:

  • In acutely or chronically infected tissues if the infected tissue is not adequately removed or not treated with appropriate therapy.
  • To replace structures that are subject to strong mechanical stress without proper stabilization
  • In patients with acute traumatic injuries with open external wounds close to the defect, which are likely to become infected, if adequate infection management is not performed.
  • In patients that have received or are to receive chemotherapy or radiation therapy at or near the implant site.
  • In patients with known allergy to bioactive glass, PEG and/or glycerol.

Possible complications and side-effects

  • Inadequate bone formation, recurrent infection in relation to osteomyelitis, and local tissue irritation.
  • General post-surgical complications such as tenderness, pain, redness, edema, seroma, seroma leakage, hematoma, swelling, fluid collection in the operation area.
  • Surgical complications related to bone grafting procedures including wound infections, delayed union, loss of reduction, loss of bone graft, graft protrusion and/or dislodgement.

 

Unit size
  • 1 cc | Ref. 16110
  • 2.5 cc | Ref. 16120
  • 5 cc | Ref. 16130
  • 10 cc | Ref. 16140
Composition
  • 53% SiO2
  • 23% Na2O
  • 20% CaO
  • 4% P2O5
  • Polyethylene glycols (PEGs) and glycerol
Specifications
  • CE marked
  • Class III medical device
  • Sterilized
  • Available in different unit sizes

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If your product label code starts with 4, please refer to the MDR-certified Instructions for Use.

41601/2 Bonalive® putty Instruction for Use (MDR-certified)

91601/5 Bonalive® putty Instruction for Use

91601/5 Bonalive® putty Instruction for Use in Hungarian, Lithuanian and Ukrainian language

Bonalive® putty Instruction for Use - Previous versions

If you have any questions, we are happy to help.

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