Highly Purified Carbonate Apatite Mineral
Highly Purified Type I Collagen
PlatFORM™ CM Blocks and PlatFORM™ CM Strips are collagen mineral composite matrices processed into either a block or strip form for surgical implantation. The principle components of PlatFORM™ CM Blocks and Strips are bovine type I collagen and anorganic bovine bone mineral. The mineral particles are dispersed within collagen fibers forming a three-dimensional open porous matrix consisting of 80% bone mineral and 20% collagen. PlatFORM™ CM Blocks and Strips are provided as a sterile, dry material that is hydrated with autogenous bone marrow at the point of use. PlatFORM™ CM Blocks and Strips are fully resorbed during the natural process of bone formation and remodeling.
PlatFORM™ CM Pads and PlatFORM™ Putty are collagen mineral composite matrices processed into pads or granular form for surgical implantation. The principle components of PlatFORM™ CM Pads and Putty are bovine type I collagen and anorganic bovine bone mineral. The mineral particles are dispersed within collagen fibers forming a three-dimensional open porous matrix consisting of 55% bone mineral and 45% collagen. PlatFORM™ CM Pads and Putty are provided as a sterile, dry material that is hydrated with autogenous bone marrow at the point of use. PlatFORM™ CM Pads can be cut into shapes and are designed to retain their shape and physical integrity following implantation into a bony site, while PlatFORM™ CM Putty can be molded to fit the bone defect. PlatFORM™ CM Pads and Putty are fully resorbed during the natural process of bone formation and remodeling.
PlatFORM™ CM Blocks and Strips, combined with autogenous bone marrow, is intended for use in filling bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone.
PlatFORM™ CM Pads and Putty, combined with autogenous bone marrow, are intended for use in filling bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone.
PlatFORM™ CM Blocks and Strips must not be used in patients with osteomyelitis at the operative site.
PlatFORM™ CM Blocks and Strips must not be used in patients with a history of anaphylaxis, history of multiple allergies, known allergies to bovine collagen, or who are being treated for desensitization to meat products because this product contains bovine collagen.
PlatFORM™ CM Pads and Putty must not be used in patients with osteomyelitis at the operative site.
PlatFORM™ CM Pads and Putty must not be used in patients with a history of anaphylaxis, history of multiple allergies, known allergies to bovine collagen, or who are being treated for desensitization to meat products because this product contains bovine collagen.
PlatFORM™ CM Blocks and Strips should not be used in fractures of the growth plate, segmental defects, direct contact with the articular space, and open fractures.
PlatFORM™ CM Pads and Putty should not be used in fractures of the growth plate, segmental defects, direct contact with the articular space, and open fractures.
Caution should be exercised when treating individuals with bleeding diatheses of any etiology.
PlatFORM™ CM Blocks and Strips should not be used to treat large defects that in the surgeon’s opinion would fail to heal spontaneously. PlatFORM™ CM Blocks and Strips must be used with internal or external fixation as indicated or required.
Use of Nonsteriodal Anti-inflammatory (NSAIDs) medications may delay graft healing. Use of alternate means of pain control should be considered whenever possible. Abstinence from smoking during and after treatment is highly advised.
If there is any evidence of compromised sterility (e.g., torn packaging), the device must not be used.
PlatFORM™ CM Blocks and Strips cannot be re-sterilized. Open, unused product must be discarded. In vivo stability may be adversely affected if re-sterilized. Cross-contamination and infection may occur if re-used.
Caution should be exercised when treating individuals with bleeding diatheses of any etiology.
PlatFORM™ CM Pads and Putty should not be used to treat large defects that in the surgeon’s opinion would fail to heal spontaneously. PlatFORM™ CM Pads and Putty must be used with internal or external fixation as indicated or required.
Use of Nonsteriodal Anti-inflammatory (NSAIDs) medications may delay graft healing. Use of alternate means of pain control should be considered whenever possible. Abstinence from smoking during and after treatment is highly advised.
If there is any evidence of compromised sterility (e.g., torn packaging), the device must not be used.
PlatFORM™ CM Pads and Putty cannot be re-sterilized. Open, unused product must be discarded. In vivo stability may be adversely affected if re-sterilized. Cross-contamination and infection may occur if re-used.
The complications and inherent risks associated with bone grafting surgery are not anticipated to increase with the use of PlatFORM™ CM Blocks and Strips and PlatFORM™ CM Pads and Putty. Potential complications of surgery include wound infection, reaction to medications or anesthesia, pain, thromboembolism, cardiac or pulmonary complications and blood loss. Potential postoperative risks include, but are not limited to hematoma, urinary retention, thombophlebitis, and continued pain. Also, all patients will be exposed to the same risks associated with any bone grafting procedure such as fracture, migration, resorption or rejection of the graft, delayed union, nonunion, or pseudoathrosis. These complications may require regrafting or revision. In addition, in some instances PlatFORM™ CM Blocks and Strips and PlatFORM™ CM Pads and Putty may need to be removed from the body, thus creating the need for a second surgery.
The possibility exists also for failure of the implant due to incorrect surgical technique, patient noncompliance during postoperative rehabilitation, and other unforeseen problems. A small number of patients may experience localized immunological reactions to this device that generally consist of transient localized edema, swelling and rash. Although there is no evidence that the device will be unsafe or ineffective in such patients, the safety and effectiveness of the device in these patients has not been established.
PlatFORM™ CM Blocks and Strips and PlatFORM™ CM Pads and Putty have not been used in clinical studies to treat patients with metabolic bone disease, significant vascular disorders or clotting disorders, uncontrolled diabetes, ankylosing spondylitis, achondroplasia, or in patients undergoing anticoagulation therapy, immunosuppressive therapy, or steroid therapy. No clinical data exists for use of PlatFORM™ CM Blocks or Strips PlatFORM™ CM Pads or Putty in children or pregnant women.
Legal Manufacturer:
Zimmer Biomet Spine, Inc.
310 Interlocken Parkway #120
Broomfield, CO 80021
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