Indications for the Arthrex ACP Double-Syringe System:

The Arthrex ACP double-syringe kit is indicated for the safe and rapid preparation of autologous platelet-rich plasma (PRP) from a small sample of peripheral blood at the patient’s point of care. The PRP may be mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.

Indications for the Arthrex ACP Max System:

The ACP Max platelet-rich plasma (PRP) system is indicated for the safe and rapid preparation of autologous PRP from a small sample of peripheral blood or a small mixture of blood and bone marrow at the patient’s point of care. The PRP may be mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.

Indications for the Angel PRP System:

‍Kits are to be used intraoperatively at the point of care for the safe and rapid preparation of autologous platelet-poor plasma and platelet concentrate (platelet-rich plasma) from a small sample of peripheral blood or a small sample of a mixture of peripheral blood and bone marrow. The platelet-poor and -rich plasmas may be mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.

Arthrex ACP and ACP Max Systems:‍

1. Blood supply limitations and previous infections, which may retard healing.
2. Any active infection or blood supply limitations.

Angel System:

1. Insufficient quantity or quality of bone.
2. Blood supply limitations and previous infections, which may retard healing.
3. Foreign body sensitivity. Where material sensitivity is suspected, appropriate tests should be made, and sensitivity ruled out prior to implantation.
4. The use of this device may not be suitable for patients with insufficient or immature bone. The physician should carefully assess bone quality before performing orthopedic surgery on patients who are skeletally immature. The use of this medical device and the placement of hardware or implants must not bridge, disturb, or disrupt the growth plate.
5. Any active infection or blood supply limitations.
6. Conditions that tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing period.
7. Do not use for surgeries other than those indicated.

Federal law restricts this device to sale by or on the order of a physician. This device is intended to be used by a trained medical professional. Do not resterilize or reuse the sterile devices. Follow the manufacturer’s instructions when using centrifuge. Use only benchtop centrifuges with swing-out rotors that securely accommodate Arthrex ACP double-syringes and ACP Max PRP system (eg, Rotofix 32 A benchtop centrifuge or Drucker Horizon Flex). Outcomes using other types of centrifuges are unknown. Follow manufacturer’s directions provided with the package insert for the anticoagulant citrate dextrose A solution (ACD-A). The safety and effectiveness of this device for bone healing and hemostasis have not been established. PRP must be used within 4 hours of blood collection. This is a single-use device. Reuse of this device could result in failure of the device to perform as intended and could cause harm to the patient and/or user. Failure to use this device in accordance with the directions for use below may result in device failure, render the device unsuitable for its intended use, or compromise the procedure. ACD-A anticoagulant and PRP prepared are not for intravenous use. For additional information on ACD-A anticoagulant, refer to the component label. Biohazard waste, such as explanted devices, needles, and contaminated surgical equipment, should be safely disposed of in accordance with the institution’s policy. Serious incidents should be reported to Arthrex, Inc., or an in-country representative, and to the health authority where the incident occurred. Some blood contacting components of the device have been sterilized with ethylene oxide, which can cause serious allergic reactions in some sensitized individuals.

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Arthrex ACP System:

Caution: Federal law restricts this device to sale by or on the order of a physician.

1. This device is intended to be used by a trained medical professional.
2. Do not resterilize this device.
3. Do not reuse this device.
4. Follow the manufacturer’s directions that are provided with the package insert for the anticoagulant citrate dextrose A solution (ACD-A).
5. The safety and effectiveness of this device for bone healing and hemostasis have not been established.
6. The PRP must be used within four (4) hours of blood collection.
7. A device labeled as a single-use device must never be reused. Reuse may pose health and/or safety risks to the patient that can include, but are not limited to cross-infection, breakage resulting in irretrievable fragments, compromised mechanical performance due to wear, lack of or no function, no guarantee of proper cleaning or sterilization of the device.
8. Detailed instructions on the use and limitations of this device should be given to the patient.
9. Failure to use this device in accordance with the directions for use below may result in device failure, render the device unsuitable for its intended use, or compromise the procedure.
10. ACD-A anticoagulant and PRP prepared are not for intravenous use. For additional information on ACD-A anticoagulant, refer to the component label.
11. Biohazard waste, such as explanted devices, needles, and contaminated surgical equipment, should be safely disposed of in accordance with the institution’s policy.
12. Serious incidents should be reported to Arthrex Inc., or an in-country representative, and to the health authority where the incident occurred.

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ACP Max System:

Caution: Federal law restricts this device to sale by or on the order of a physician.

1. This device is intended to be used by a trained medical professional.
2. Do not resterilize this device.
3. Do not reuse this device.
4. Follow the manufacturer’s instructions when using centrifuge. Use only benchtop centrifuges with swing-out rotors that securely accommodate Arthrex ACP double-syringes and ACP Max PRP system (eg, Rotofix 32 A benchtop centrifuge or Drucker Horizon Flex). Outcomes using other types of centrifuges are unknown.
5. Follow the manufacturer’s directions that are provided with the package insert for the anticoagulant citrate dextrose A solution (ACD-A).
6. The safety and effectiveness of this device for bone healing and hemostasis have not been established.
7. The PRP must be used within four (4) hours of blood collection.
8. This is a single-use device. Reuse of this device could result in failure of the device to perform as intended and could cause harm to the patient and/or user.
9. Failure to use this device in accordance with the directions for use below may result in device failure, render the device unsuitable for its intended use, or compromise the procedure.
10. ACD-A anticoagulant and PRP prepared are not for intravenous use. For additional information on ACD-A anticoagulant, refer to the component label.
11. Biohazard waste, such as explanted devices, needles, and contaminated surgical equipment, should be safely disposed of in accordance with the institution’s policy.
12. Serious incidents should be reported to Arthrex Inc., or an in-country representative, and to the health authority where the incident occurred.
13. Some blood contacting components of the device have been sterilized with ethylene oxide, which can cause serious allergic reactions in some sensitized individuals.

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Angel System:

Caution: Federal law restricts this device to sale by or on the order of a physician.

1. This device is intended to be used by a trained medical professional.
2. Do not resterilize this device.
3. The ABS-10071 Blood Draw Kit protective bag is not a sterile barrier. The contents of the inner pouches are sterile.
4. Preoperative and operating procedures, including knowledge of surgical techniques and proper selection and placement of the device, are important considerations in the successful utilization of this device.
5. A device labeled as a single-use device must never be reused. Reuse may pose health and/or safety risks to the patient that can include, but are not limited to, cross-infection, breakage resulting in irretrievable fragments, compromised mechanical performance due to wear, lack of or no function, no guarantee of proper cleaning or sterilization of the device.
6. Biohazard waste, such as explanted devices, needles, and contaminated surgical equipment, should be safely disposed of in accordance with the institution’s policy.
7. Serious incidents should be reported to Arthrex Inc., or an in-country representative, and to the health authority where the incident occurred.

Arthrex ACP and ACP Max Systems:

1. Infections, both deep and superficial
2. Allergies and other reactions to device materials
3. Hematoma
4. Damage to blood vessels and nerve damage resulting in pain or numbness from autologous sampling
5. Delayed wound healing

Angel cPRP System:

1. Infections, both deep and superficial
2. Foreign body reactions
3. Hematoma