Catalyft LS Expandable Interbody System

K212653 · Medtronic Sofamor Danek USA, Inc. · MAX · Nov 19, 2021 · Orthopedic

Device Facts

• Record ID: K212653
• Device Name: Catalyft LS Expandable Interbody System
• Applicant: Medtronic Sofamor Danek USA, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Nov 19, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Catalyft™ LS Expandable Interbody System is indicated for use as an intervertebral body fusion device in sketetally 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). Additionally, the Catalyf(™ LS Expandable Interbody System can be used with patients diagnosed with multilevel degenerative scoliosis and sagittal deformities as an adjunct to fusion. When used in patients as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditional supplemental fixation (e.g posterior fixation) must be used. 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 bone, and/or demineralized allograft bone with bone marrow aspirate. These implants may be implanted via a variety of open or minimally invasive anterior or oblique approach. The Catalyfi™ LS Expandable interbody system may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the Catalyft™ LS Expandable interbody device is intended to be used with 4 titanium alloy screws. If the physician chooses to use less than 4 or none of the provided screws, additional supplemental fixation in the lumbar spine must be used to augment stability. Implants with lordosis angles greater than 20° are intended to be used with 4 screws and supplemental fixation.

Device Story

The Catalyft™ LS Expandable Interbody System consists of titanium alloy (Ti-6Al-4V ELI) interbody fusion implants, instruments, and trays. Implants are surgically placed between lumbar or lumbosacral vertebral bodies to provide structural support and restore spinal alignment/lordosis during fusion procedures. The device features an expandable height and lordosis mechanism that moves both endcaps to match patient anatomy and vertebral endplate curvature. It is implanted via open or minimally invasive anterior or oblique approaches. The system may be used as a stand-alone device (with 4 titanium alloy screws) or with supplemental posterior fixation. Surgeons use the device to facilitate fusion using autogenous or allograft bone grafts. The device benefits patients by providing adjustable height and lordosis to correct spinal deformities and stabilize the lumbar spine, promoting bone fusion during the healing process.

Clinical Evidence

Bench testing only. Testing included static and dynamic compression (ASTM F2077-18), static and dynamic compression shear (ASTM F2077-18), subsidence (ASTM F2267-04(2018)), expulsion (ASTM F-04.25.02.02), bone screw push-out, and MRI safety evaluation (ASTM F2052-15, F2213-17, F2219-07, F2182-19e).

Technological Characteristics

Material: Titanium alloy (Ti-6Al-4V ELI). Design: Expandable height and lordotic interbody fusion implant with double-curved endcaps. Standards: ASTM F2077-18, ASTM F2267-04(2018), ASTM F2052-15, F2213-17, F2219-07, F2182-19e. Connectivity: None. Energy source: None (mechanical). Sterilization: Provided sterile.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous lumbar levels (L2-S1) or multilevel degenerative scoliosis and sagittal deformities as an adjunct to fusion. Requires 6 months of prior 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

• SOVEREIGN™ Spinal System (K172328, K091813)
• BASE Interfixated Titanium (K201820)
• CRESCENT™ PEEK (K094025)
• ELEVATE™ Spinal System (K142559)
• CLYDESDALE™ Spinal System (K132897)
• CATALYFT™ PL Expandable Interbody System (K210425)

Submission Summary (Full Text)

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December 27, 2022

Medtronic Sofamor Danek USA, Inc. Madhuvanthi Soundirarajan Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K212653

Trade/Device Name: Catalyft™ LS Expandable Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, OVD

Dear Madhuvanthi Soundirarajan:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated November 19, 2021. Specifically, FDA is updating this SE Letter to correct the product code as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Brent Showalter, Ph.D., OHT6: Office of Orthopedic Devices, [phone], [e-mail].

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

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November 19, 2021

Medtronic Sofamor Danek USA, Inc. Madhuvanthi Soundirarajan Regulatory Affairs Specialist 1800 Pyramid Place Memphis. Tennessee 38132

Re: K212653-S001

Trade/Device Name: Catalyft™ LS Expandable Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, KWQ, OVD Dated: November 8, 2021 Received: November 10, 2021

Dear Madhuvanthi Soundirarajan:

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 (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 located 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.

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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely.

Brent Showalter -S

Brent L. 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

510(k) Number (if known)

K212653

#### Device Name Catalyft™ LS Expandable Interbody System

#### Indications for Use (Describe)

The Catalyfi™ LS Expandable Interbody System is indicated for use as an intervertebral body fusion device in sketetally 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). Additionally, the Catalyf(™ LS Expandable Interbody System can be used with patients diagnosed with multilevel degenerative scoliosis and sagittal deformities as an adjunct to fusion. When used in patients as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditional supplemental fixation (e.g posterior fixation) must be used. 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 bone, and/or demineralized allograft bone with bone marrow aspirate.

These implants may be implanted via a variety of open or minimally invasive anterior or oblique approach. The Catalyfi™ LS Expandable interbody system may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the Catalyft™ LS Expandable interbody device is intended to be used with 4 titanium alloy screws. If the physician chooses to use less than 4 or none of the provided screws, additional supplemental fixation in the lumbar spine must be used to augment stability. Implants with lordosis angles greater than 20° are intended

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

>> Prescription Use (Part 21 CFR 801 Subpart D)

to be used with 4 screws and supplemental fixation.

| Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary

# MEDTRONIC Catalyft™ LS Expandable Interbody System

## August 2021

| Submitter | Medtronic Sofamor Danek, USA Inc.<br>1800 Pyramid Place<br>Memphis, Tennessee 38132<br>Telephone: [phone]<br>Fax: [phone] |
|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Madhuvanthi Soundirarajan<br>Regulatory Affairs Specialist<br>Email: [e-mail]<br>Telephone: [phone] |
| Date Prepared | August 2021 |
| Name of Device | Catalyft™ LS Expandable Interbody System |
| Common Name | Interbody Cages |
| Classification Name | Intervertebral Body Lumbar Fusion Device with Bone Graft (21<br>CFR 888.3080) |
| Classification | Implants: Class II |
| Product Codes | MAX (888.3080)<br>OVD (888.3080) |
| Predicate Devices | Predicate 1 (Primary Predicate) – SOVEREIGNT™ Spinal<br>System (K172328, S.E 11/02/2017) and (K091813, S.E<br>11/17/2009).<br>Predicate 2 – BASE Interfixated Titanium (K201820, S.E<br>09/25/2020)<br>Predicate 3-CRESCENT™ PEEK (K094025, S.E. 04/26/2010)<br>Predicate 4 – ELEVATE™ Spinal System (K142559, S.E<br>06/09/2015)<br>Predicate 5- CLYDESDALE™ Spinal System (K132897, S.E<br>12/11/2013) |
| | Predicate 6 - CATALYFT™ PL Expandable Interbody<br>System (K210425, S.E 05/24/21) |
| | The Catalyft™ LS Expandable Interbody system consists of<br>implants, instruments, and trays. The implants are provided sterile |
| Description | and are intended to be surgically implanted between two lumbar or<br>lumbosacral vertebral bodies to give support and correction during<br>lumbar intervertebral body fusion. |
| | Catalyft™ LS Expandable Interbody System implants are<br>expandable height & lordotic titanium interbody fusion<br>implants. The subject interbody implants have double curved<br>endcaps geometry that will allow the implants to seat inside the<br>vertebral endplate curvature. The interbody implants are made of<br>titanium alloy (Ti-6Al-4V Eli) and they expand for<br>adjustable height and adjustable lordosis. The purpose of the<br>adjustable height and lordosis is to allow the surgeons to have<br>better control and restoration of spinal alignment and lordosis in<br>patients and to appropriately size the interbody to match the<br>patient anatomy. |
| Indications for Use | The Catalyft™ LS Expandable Interbody System is indicated for<br>use as an intervertebral body fusion device in skeletally mature<br>patients with degenerative disc disease (DDD - defined by<br>discogenic back pain with degeneration of the disc confirmed by<br>patient history and radiographic studies) at one or two contiguous<br>levels of the lumbar spine (L2-S1). Additionally, the Catalyft™<br>LS Expandable Interbody System can be used with patients<br>diagnosed with spinal multilevel degenerative scoliosis and<br>sagittal deformities as an adjunct to fusion. When used in patients<br>as an adjunct to fusion in patients diagnosed with multilevel<br>degenerative scoliosis and sagittal deformity conditions, additional<br>supplemental fixation (e.g posterior fixation) must be used. These<br>patients should be skeletally mature and have undergone 6 months<br>of non-operative treatment prior to surgery. Implants are used to<br>facilitate fusion in the lumbar spine using autogenous bone graft<br>and/or allograft bone graft comprised of cancellous<br>and/or corticocancellous bone, and/or demineralized allograft<br>bone with bone marrow aspirate. These implants may be<br>implanted via a variety of open or minimally invasive approaches.<br>These approaches include anterior and or oblique approach.<br>The Catalyft™ LS Expandable interbody system cages used with<br>4 titanium alloy screws may be used as a stand-alone device up to<br>20°lordosis. If the physician chooses to use less than 4 or none of<br>the provided screws, additional supplemental fixation in the |
| Comparison of<br>Technological<br>Characteristics with<br>the Predicate Devices | lumbar spine must be used to augment stability. Implants with<br>lordosis angles greater than 20° are intended to be used with 4<br>screws and supplemental fixation<br><br>Catalyft™ LS Expandable Interbody System has the same<br>fundamental scientific technology, indications for use, design,<br>material, and levels of attachment as the predicate devices. The<br>predicate and the subject devices are intended for stabilization use<br>and to promote bone fusion during the normal healing process<br>following surgical correction of disorders of the spine.<br><br>The subject interbody implant has a similar expansion mechanism<br>as the Predicate 4 ELEVATE™ Spinal System implant. However,<br>the subject implant has expandable height and lordosis moving<br>both the endcaps during the expansion, whereas the ELEVATE™<br>implant's bottom endcap remains in fixed position. |
| Performance Data | The subject Catalyft™ LS implants underwent the following<br>verification tests:<br>Static and Dynamic Compression per ASTM F2077-18 Static and Dynamic Compression Shear per ASTM F2077-18 Subsidence per ASTM F2267-04(2018) Expulsion per ASTM F-04.25.02.02 Bone Screw Push Out MRI Safety Evaluation per ASTM F2052-15, F2213-17, F2219-07, F2182-19e |
| Conclusion | Based on the supporting evidence provided, Medtronic believes the<br>subject devices are substantially equivalent to the below predicates.<br>Predicate 1 (Primary Predicate) – SOVEREIGN™<br>Spinal System (K172328, S.E<br>11/02/2017) and (K091813, S.E 11/17/2009). Predicate 2 – BASE Interfixated Titanium (K201820,<br>S.E 09/25/2020) Predicate 3 – CRESCENT™ PEEK (K094025, S.E.<br>04/26/2010) Predicate 4 - ELEVATE™ Spinal System (K142559,<br>S.E 06/09/2015) Predicate 5- CLYDESDALE™ Spinal<br>System (K132897, S.E 12/11/2013) Predicate 6 - CATALYFT ™ PL Expandable Interbody<br>System (K210425, S.E 05/24/21) |

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