Catalyft PL Expandable Interbody System

K253011 · Medtronic Sofamor Danek USA, Inc. · MAX · Jul 17, 2026 · Orthopedic

Device Facts

• Record ID: K253011
• Device Name: Catalyft PL Expandable Interbody System
• Applicant: Medtronic Sofamor Danek USA, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Jul 17, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Catalyft PL Expandable Interbody is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD - defined by discogenic 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 diagnosed 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 demineralied allograft bone with bone marrow aspirate. These implants are intended for use with supplemental internal fixation systems.

Device Story

Expandable titanium alloy interbody device; inserted between lumbar/lumbosacral vertebral bodies to provide support and correction during fusion surgery; central cavity packed with autogenous or allograft bone graft; used with supplemental internal fixation systems; operated by surgeons in clinical settings; facilitates spinal fusion; benefits patients by restoring disc height and stabilizing vertebral segments.

Clinical Evidence

Bench testing only. Non-standard axial compression fatigue testing conducted to evaluate device performance under off-loaded conditions.

Technological Characteristics

Expandable interbody device; material: titanium alloy; form factor: various widths, lengths, heights, and lordotic angles; central cavity for bone graft; requires supplemental internal fixation.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous lumbar levels (L2-S1), including those with up to Grade 1 spondylolisthesis or retrolisthesis, or spinal deformities requiring fusion. Patients must have failed 6 months of non-operative treatment.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• Catalyft™ PL Expandable Interbody System (K021425)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

July 17, 2026

Medtronic Sofamor Danek USA, Inc.

Michelle Obenauer

Sr. Regulatory Affairs Director

1800 Pyramid Pl.

Memphis, Tennessee 38132

Re: K253011

Trade/Device Name: Catalyft™ PL Expandable Interbody System

Regulation Number: 21 CFR 888.3080

Regulation Name: Intervertebral body fusion device

Regulatory Class: Class II

Product Code: MAX

Dated: July 9, 2026

Received: July 10, 2026

Dear Michelle Obenauer:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

U.S. Food & Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

www.fda.gov

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K253011 - Michelle Obenauer

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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K253011 - Michelle Obenauer

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Sincerely,

# BRENT SHOWALTER -S

Brent Showalter, Ph.D.

Assistant Director

DHT6B: Division of Spinal Devices

OHT6: Office of Orthopedic Devices

Office of Product Evaluation and Quality

Center for Devices and Radiological Health

Enclosure

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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K253011 | ? |
| Please provide the device trade name(s). | | ? |
| Catalyft PL Expandable Interbody System | | |
| Please provide your Indications for Use below. | | ? |
| The Catalyft PL Expandable Interbody is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD - defined by discogenic 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 diagnosed 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 demineralied allograft bone with bone marrow aspirate. These implants are intended for use with supplemental internal fixation systems. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |

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K253011

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# 510(k) Summary

# MEDTRONIC

# Catalyft™ PL Expandable Interbody System

July 16, 2026

| I. Submitter | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, Tennessee 38132 |
| --- | --- |
| Contact Person | Michelle Obenauer Sr. Regulatory Affairs Director Email: [e-mail] |
| II. Name of Device | Catalyft™ PL Expandable Interbody System |
| Common Name | Intervertebral fusion device with bone graft, lumbar |
| Classification Name | Intervertebral body fusion device |
| Regulation Number | 21 CFR 888.3080 |
| Classification | Class II |
| Product Code | MAX |
| III. Predicate Device | Catalyft™ PL Expandable Interbody System K021425, S.E. 05/24/2021 |
| IV. Device Description | 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. |
| V. Indications for Use | 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 |

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K253011^{}[] Page 2 of 2

| | 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. |
| --- | --- |
| **VI. Comparison of Technological Characteristics with the Predicate Device** | The subject Catalyft™ PL Expandable Interbody System has the same intended use, indications for use, materials, design, fundamental technology, and sterilization as the predicate Catalyft™ PL Expandable Interbody System (K021425, S.E. 05/24/2021). |
| **VII. Performance Data** | In accordance with the Intervertebral Body Fusion Device – Class II Special Controls Guidance for Industry and FDA Staff, Medtronic has evaluated the subject devices to demonstrate substantial equivalence to the predicate device. Non-standard axial compression fatigue testing designed to cycle the device through an off-loaded condition was conducted to support the proposed labeling changes. |
| **VIII. Conclusion** | Based on the supporting evidence provided in this premarket notification, Medtronic believes the subject devices are substantially equivalent to the predicate devices. |