INDICATIONS, SAFETY, AND WARNINGS Catalyft™ PL Expandable Interbody


This device is a fusion device intended for stabilization and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine. The product should be implanted only by a physician thoroughly knowledgeable in the implant's material and surgical aspects and instructed as to its mechanical and material applications and limitations.


The Catalyft™ PL Expandable Interbody System is an expandable titanium alloy interbody device consisting of interbodies of various widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate. Device lifetime for the Catalyft™ PL Expandable Interbody System is one year in which the device is expected to achieve its performance (e.g. immobilization and stabilization as an adjunct to fusion) and maintain its safety until fusion occurs. After fusion, the device is further designed and tested to survive the life of the patient. No warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.


The Catalyft™ PL Expandable Interbody System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. Additionally, the Catalyft™ PL Expandable Interbody System can be used with patients diagnose with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone 6 months of non-operative treatment prior to surgery. Implants are used to facilitate fusion in the lumbar spine using autogenous bone graft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate. These implants are intended for use with supplemental internal fixation systems.


The Catalyft™ PL Expandable Interbody System is not intended for cervical or thoracic spine use. Contraindications include: 

  • Infection local to the operative site.
  • Signs of local inflammation.
  • Fever or leukocytosis.
  • Morbid obesity.
  • Pregnancy.
  • Mental illness. 
  • Condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors or congenital abnormalities, fracture local to the operating site, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count.
  • Suspected or documented allergy or intolerance to composite materials.
  • Cases not needing a fusion.
  • Cases not described in the indications.
  • Patients unwilling to cooperate with postoperative instructions.
  • Patients with a known hereditary or acquired bone friability or calcification problem
  • These devices must not be used for pediatric cases, nor where the patient still has general skeletal growth.
  • Spondylolisthesis unable to be reduced to Grade 1.
  • Cases where implant components selected for use would be too large or too small to achieve a successful result.
  • Cases requiring the mixing of metals from two different components or systems.
  • Patients having inadequate tissue coverage over the operative site or inadequate bone stock or quality.
  • Patients in which implant use would interfere with anatomical structures or expected physiological performance.
  • Prior fusion at the level to be treated.

Nota bene: Although not absolute contraindications, conditions to be considered as potential factors for not using this device include:

  • Severe bone resorption.
  • Osteomalacia.
  • Severe osteoporosis.

Take into consideration that the segmental stability can be affected by a variety of factors.


Adverse effects may occur when the device is used either with or without associated instrumentation. The risk of adverse effects as a result of movement and non-stabilization may increase in cases where associated complementary support is not employed. Potential adverse events include:

  • Implant migration.
  • Breakage of the device(s).
  • Foreign body reaction to the implants including possible tumor formation, auto immune disease, and/or scarring.
  • Pressure on the surrounding tissues or organs.
  • Loss of proper spinal curvature, correction, height, and/or reduction.
  • Infection.
  • Bone fracture or stress shielding at, above, or below the level of surgery.
  • Non-union (or pseudoarthrosis).
  • Loss of neurological function, appearance of radiculopathy, dural tears, and/or development of pain. 
  • Neurovascular compromise including paralysis, temporary or permanent retrograde ejaculation in males, or other types of serious injury.
  • Cerebral spinal fluid leakage.
  • Hemorrhage of blood vessels and/or hematomas.
  • Discitis, arachnoiditis, and/or other types of inflammation.
  • Deep venous thrombosis, thrombophlebitis, and/or pulmonary embolus.
  • Bone graft donor site complication.
  • Inability to resume activities of normal daily living.
  • Early or late loosening or movement of the device(s).
  • Urinary retention, loss of bladder control, or other types of urological system compromise.
  • Scar formation possibly causing neurological compromise or compression around nerves and/or pain.
  • Fracture, microfracture, resorption, damage, or penetration and/or retropulsion of any spinal bone (including the sacrum, pedicles, and/or vertebral body) and/or bone graft or bone graft harvest site at, above, and/or below the level of surgery.
  • Retropulsed graft.
  • Herniated nucleus pulposus, disc disruption or degeneration at, above, or below the level of surgery.
  • Loss of or increase in spinal mobility or function.
  • Reproductive system compromise, including sterility, loss of consortium, and sexual dysfunction.
  • Development of respiratory problems (e.g. pulmonary embolism, atelectasis, bronchitis, pneumonia, etc.).
  • Change in mental status.
  • Cessation of any potential growth of the operated portion of the spine. 
  • Death.

Note: additional surgery might become necessary to correct adverse effects.


A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where other patient conditions may compromise results. Use of this product without autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone or in cases that do not develop a union will not be successful.

Preoperative and operating procedures, including knowledge of surgical techniques, good reduction, and correct selection and placement of implants are important considerations in the successful use of the system. Further, proper selection and compliance of the patient will greatly affect results. Patients who smoke were shown to have a reduced incidence of bone fusion. These patients should be advised of this fact and warned of this consequence. Obese, malnourished, and/or alcohol/ drug abuse patients and those with poor muscle and bone quality and/or nerve paralysis are also poor candidates for spinal fusion.

Patients with previous spinal surgery at the levels to be treated may have different clinical outcomes compared to those without a previous spinal surgery.

Document the used implants per patient with REF and LOT, so tracking, which is required by law, is guaranteed. Implants are only for single use. Do not re-process or re-use devices labeled as single use devices. Re-processing or re-use of single use devices may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death.

Physician note: although the physician is the learned intermediary between the company and the patient, the important medical information in this document should be conveyed to the patient.

For US audiences only

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.


Selection of proper size, shape, and design of the implant for each patient is crucial to success of the procedure. Surgical implants are subject to repeated stresses in use, and their strength is limited by the need to adapt the design to the human anatomy. Unless great care is taken in patient selection, placement of implant, and postoperative management to minimize stresses on the implant, such stresses may cause material fatigue and consequent breakage or loosening of the device before the fusion process is complete, which may result in further injury or the need to remove the device prematurely.


Installation and positional adjustment of implants must only be accomplished with special ancillary instruments and equipment supplied and designated by Medtronic. In the interests of patient safety, do not use Medtronic implants with devices from any other source.

Never, under any circumstances, reuse a Catalyft™ PL Expandable Interbody System implant. Even when a removed implant appears undamaged, it may have small defects or internal stress patterns that may lead to early breakage.


  • Only patients that meet the criteria described in the indications should be selected.
  • Patient conditions and/or predispositions such as those addressed in the contraindications should be avoided.
  • Care should be taken when handling and storing the device(s). They should not be scratched or damaged. Devices should be protected during storage especially from corrosive environments.
  • The surgeon should be familiar with the various devices before use and should personally verify all devices are present before surgery.
  • The size of device for the case should be determined prior to surgery. An adequate inventory of implant sizes should be available at the time of surgery, including sizes larger and smaller than those expected to be used.
  • Additional sterile implants should be available in case of an unexpected need.


  • The instructions in any Catalyft™ PL Expandable Interbody System surgical technique manual should be carefully followed.
  • At all times, extreme caution should be used around the spinal cord and nerve roots. Damage to the spinal cord and/or nerves will cause loss of neurological functions.
  • Breakage, slippage, or misuse of instruments or implants may cause injury to the patient or operative personnel.
  • To ensure proper fusion below and around the location of the fusion, autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate must be used.
  • Bone cement should not be used because this material may make removal of components difficult or impossible.


The physician’s postoperative directions and warnings to the patient and the corresponding patient compliance are extremely important.

  • Detailed instructions on use and limitations of the device should be given to patients. Patients must be warned that loosening, and/or breakage of the device(s) are complications which may occur as result of early or excessive weightbearing, muscular activity, or sudden jolts or shock to the spine.
  • Patients should be advised not to smoke or consume excess alcohol during period of the bone fusion process.
  • Patients should be advised of the inability to bend at the point of spinal fusion and taught to compensate for this permanent physical restriction in body motion.
  • It is important that immobilization of union is established and confirmed by roentgenographic examination. If a non-union develops or if components loosen, migrate, and/or break, devices should be revised and/or removed immediately before serious injury occurs.
  • Catalyft™ PL Expandable Interbody System implants are interbody devices and are intended to stabilize the operative area during the fusion process.
  • Retrieved devices should be treated in such a manner that reuse in another surgical procedure is not possible.
  • When explanting and/or disposing of a device, avoid exposure to bodily substances such as blood, tissue, etc., as contact could lead to infection or disease. Always wear and use proper equipment, taking special care with sharp objects and needles. Follow your healthcare center’s policy regarding both the disposal of devices and any events of exposure.


Visually inspect all sterile-barrier packaging before use. If the sterile barrier is damaged or the integrity is compromised, do not use the product. Contact Medtronic for return information.

Visually inspect the device before use. If the device is damaged, do not use the product. Contact Medtronic for return information.


Devices are supplied sterile. Packages for each of the components should be intact upon receipt. Once the seal on the sterile package is broken, the product should not be re-sterilized. If a loaner set is used, all sets and components should be carefully checked for completeness and to ensure there is no damage prior to use.


The Catalyft™ PL Expandable Interbody System was determined to be MR-Conditional based on non-clinical testing and engineering rationales. A patient with this device can be safely scanned immediately after device placement under the following conditions:

  • Static magnetic field of 1.5 and 3.0-Tesla.
  • Maximum spatial gradient magnetic field of 3000-Gauss/cm (30 T/m).
  • Maximum whole-body average specific absorption rate (SAR) of 2.0 W/kg under normal operating mode.

Under the scan conditions defined, a worst-case interbody fusion device representative of the Catalyft™ PL Expandable Interbody System produced a maximum temperature rise of <5.0°C after 15 minutes of continuous scanning.

In non-clinical testing, the image artifact caused by a worst-case interbody fusion device representative of the Catalyft™ PL Expandable Interbody System extends approximately 13mm for a spin echo sequence and 23mm for a gradient echo sequence in a 3-Tesla MR system. Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary.

If the Catalyft™ PL Expandable Interbody System is used in connection with any device which is not MR Conditional, be advised this combination was not tested in the MR environment and, therefore, higher heating and possible injury to the patient may occur. The presence of other implants or the health state of the patient may require modification of MR conditions.


To report any product problems, contact Medtronic.

Patients in the European Union experiencing a serious incident in relation to the device should contact Medtronic and the competent authority of the Member State in which they are established.


Recommended directions for use of this system (surgical operative techniques) are available at no charge upon request. If further information is required, contact Medtronic.

After the EUDAMED website is launched, the Summary of Safety and Clinical Performance (SSCP) can be found at