Bio-Sav Bone Mill

The Bio-Sav Bone Mill™ is the first single-use, large-case disposable bone mill designed to provide reliable and efficacious prepared autograft or allograft scaffold material combinations for orthopedic reconstruction. Applications include arthroplasty revisions in spine, total joints, and other orthopedic procedures including maxillofacial reconstructions and reducing trauma where the patient’s bone is being harvested. Our Bio-Sav Bone Mill™ ensures maximum safety for both the OR staff and patient, while preserving cell viability of the optimally-sized bone particulate. It is safe to use, compact in size, cost-effective, and guarantees consistently-sized, efficacious harvested bone, every time.

Benefits

  • AFFORDABLE – Low barrier pricing for hospitals and no upfront capital equipment investments.
  • STERILE – Single use disposability ensures the product is sterile and free from previous surgery cross-contamination.
  • ZERO MAINTENANCE – No cleaning, assembling or re-sterilization needed and no follow-on maintenance costs in an OR setting
  • AN EXACTING PRODUCT – Our contra rotation milling device reduces bone to a particulate size (i.e. 1 to 3-mm), ideal for graft scaffolding.
  • ERGONOMIC FOOTPRINT – Intuitive design, minimizes operator fatigue and minimizes required space on the surgical back table.
  • OPERATOR AND PATIENT PROTECTION – Provides a safe experience for the operator and guarantees a high standard of sterility to protect each patient.

Indications

The Bio-Sav Bone Mill™ is indicated and recommended for the following uses:

  • Any surgical procedure where fusion, reconstruction, or orthopedic arthroplasty revisions are to be performed.
  • Any Maxillofacial reconstructions that are performed
  • Any surgical procedure where allograft, autograft and/or other osteo inductive or conductive materials needs preparation, mixed or ground into an optimized size and consistency to enhance grafting surface area, vascular in-growth and conformability to act as a fusion locus, substrate or void/gap filling material.

    Problem

    Spinal Fusion typically includes a patient’s bone to be harvested for reintroduction into the patient at a later time during surgery. Reducing harvested bone is often technically cumbersome and time-consuming in current systems, and problematic in the preservation of its efficacy when surgeries, particularly complex surgeries, demand consistent sized efficacious harvested bone. Powered bone mill solutions are currently the most commonly employed solutions for reducing harvested bone in the market. Yet these powered bone mills very often prove unreliable because they deliver inconsistent sized bone with possible efficacy issues such as potential bone overheating.

    Solution

    The Bio-Sav Bone Mill™ is the first large case disposable bone mill that ensures maximum safety for both the OR staff and patient, where cell viability within the bone particulate is preserved, where bone particulate is optimally sized every time, and where this recognized cost competitive solution for hospitals helps reduce its OR product spend on a per procedure basis.

    Results

    • SAVES on back table OR support time as a single pass system.
    • REDUCES general overhead costs versus products that require re-sterilization between surgeries.
    • PRESERVES bone particulate efficacy for scaffolding purposes.
    • PREVENTS cross contamination issues akin to capital equipment type bone mills.
    • OFFERS a new milling option when large case bone harvesting surgeries are scheduled.

    How To Use

    Working with this bone mill atop a sterile back table there is little table space required for its operations. The operator simply places the prepared graft material into the bone mill chamber, applies slight downward pressure onto the plunger while turning the milling wheel. The reduced bone drops into the tray below where the particulate is ready for immediate use in the patient.

    FAQ

    Which surgeries are best suited for the Bio-Sav Bone Mill™?
    Any mid-sized to large case surgeries that require harvested bone graft material. Applications include Complex Spine, Total Joint, Trauma, and Maxillofacial orthopedic procedures where bone harvesting is required. As an example, during a multi-level spine procedure where local patient bone is harvested for a 2-level lumbar fusion via an open or minimally invasive procedure, the Bio-Sav Bone Mill™ is ideal for the bone harvesting procedure. The Bio-Sav Bone Mill™, which is a ready to use product, is also ideal for unplanned Trauma reconstructive surgeries.
    Why is the Bio-Sav Bone Mill™ a single-use device?
    As a single-use device, it was designed predominantly to be the safest, most cost-effective large case bone mill in the market, and to that end the product was designed intentionally to not be re-sterilized via traditional hospital methods.
    Why is the tray called a Portion Control Bone Tray?
    Inside the Bio-Sav Bone Mill™ Tray there is a midline rib that allows the surgeon to visually allocate equal parts of harvested particulate bone when such an apportionment is needed (i.e. 2-Level Fusion).
    Can the Bio-Sav Bone Mill™ be used to mix autograft with other outside Osteobiologics?
    Absolutely! It is an ideal mixing system to create uniform biologic mixes of autograft and other supplemental bone products. There is no excessive heat generated during the milling process, nor excessive blunt force imposed of the stem cells of the bone due to high-speed rotating blades. The low-speed cutting process of the Bio-Sav Bone Mill provides optimal bone size for scaffolding while preserving bone efficacy versus its competitors in the market.
    What size particulate will be generated by the Bio-Sav Bone Mill™, and is there a percentage of bone loss during the bone reduction process?
    The Bio-Sav creates an ideal bone particulate that is sized between 1 and 3-mm length, while there is little bone loss when the processed bone finds its way into the Bone Portion Management Tray.
    Is the Bio-Sav Bone Mill FDA approved?
    Bio-Sav is an FDA registered Class I Medical Device.
    How easy is the Bio-Sav Bone Mill™ to use in a tense OR setting?
    The product was designed as an intuitive, easy-to-use product in part to support Trauma Orthopedic procedures. This product is a single-use bone mill that is available for use right out of the box! Training is also available through local representation, via a training video on this website, or through other handout information that can be downloaded from this website.
    Are there any potential adverse effects to be aware of?
    Use of the product on demineralized osteopenic or osteoporotic bone may yield product too finely pulverized for optimal use. In this case, test a small amount of bone to determine sufficient structural integrity.

    Contraindications

    Use of this product is contraindicated where the use of autograft, allograft or other osteoinductive and conductive materials may be contraindicated including cases of severe osteopenia or osteoporosis.

    Adverse Effects

    Use of the product on demineralized osteopenic or osteoporotic bone may yield product too finely pulverized for optimal use. In this case, test a small amount of bone to determine sufficient structural integrity.

    Warnings & Precautions

    Do not use this product if the inner packaging has been breached in any manner prior to its usage – prematurely opened or damaged. Do not use this product in a manner inconsistent with product labeling. This device is a single patient use product. As with any surgical procedure, care should be exercised in treating those individuals with underlying pre-existing medical conditions that may affect the surgical success of the procedure. This includes, but is not limited to, those individuals with diabetes, malnutrition, tobacco product use, steroid or non-steroidal anti-inflammatory use (NSAIDS), high dose radiation therapy and or other pathology that may increase surgical risk or affect surgical outcomes and fusion success rates.

    Use of this product according to its labeling does not constitute any guarantee or warranty, either implied or in writing, with respect to a surgical outcome, fusion rates, or durability of such outcomes. Federal Law (US) restricts this device only to be sold by or on the order of a physician.