Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology

K223153 · Medtronic Sofamor Danek USA, Inc. · MAX · Dec 16, 2022 · Orthopedic

Device Facts

• Record ID: K223153
• Device Name: Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology
• Applicant: Medtronic Sofamor Danek USA, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Dec 16, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Catalyft™ LS Expandable Interbody System device, including those with or without micro- and nano-roughened surface textured features, 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). Additionally, the Catalyft™ 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 and/or corticocancellous 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 Catalyft™ LS Expandable Interbody System device may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the Catalyfi™ LS Expandable Interbody System 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

Expandable titanium alloy interbody device; surgically implanted between lumbar/lumbosacral vertebral bodies to provide support and correction during fusion. Features central cavity for packing with autogenous/allograft bone graft. Incorporates Titan nanoLOCK™ surface technology (micro/nano-roughened) to improve bone fixation. Implanted via open or minimally invasive anterior/oblique approaches. Used by surgeons in clinical settings. Provides structural support to facilitate spinal fusion; benefits patients by stabilizing vertebral segments and correcting deformity. Can be used as stand-alone (with 4 titanium screws) or with supplemental fixation.

Clinical Evidence

Bench testing only. Performed static/dynamic compression (ASTM F2077-18), compression shear (ASTM F2077-18), subsidence (ASTM F2267-04(2018)), expulsion testing, wear debris (ASTM F1877), and MRI safety evaluation (ASTM 2503-20, F2182-19e, F2052-21, F2213-17, F2219-07).

Technological Characteristics

Titanium alloy expandable interbody cage. Features Titan nanoLOCK™ surface technology (nano-scale textured features). Sterile. Dimensions vary by patient anatomy. Mechanical stabilization via expansion mechanism. No software or energy source.

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

• Catalyft™ LS Expandable Interbody System (K212653)
• Anteralign LS™ Interbody System with Titan nanoLOCK™ Surface Technology (K214010)
• Crescent™ PEEK (K094025, K133216, K171031)
• Clydesdale™ Spinal System (K100175, K132897, K133577)
• Elevate™ Spinal System (K142559)

Submission Summary (Full Text)

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December 16, 2022

Medtronic Sofamor Danek USA, Inc. Alex Underberg Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K223153

Trade/Device Name: Catalyft™ LS Expandable Interbody System with Titan nanoLOCK™ Surface Technology Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, OVD Dated: October 4, 2022 Received: October 6, 2022

Dear Alex Underberg:

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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

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

510(k) Number (if known)

K223153

#### Device Name

Catalyft™ LS Expandable Interbody System with Titan nanoLOCK™ Surface Technology

#### Indications for Use (Describe)

The Catalyft™ LS Expandable Interbody System device, including those with or without micro- and nano-roughened surface textured features, 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). Additionally, the Catalyft™ 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 and/or corticocancellous 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 Catalyft™ LS Expandable Interbody System device may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the Catalyfi™ LS Expandable Interbody System 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

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

| <div> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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## 510(k) Summary

## MEDTRONIC

# Catalyft™ LS Expandable Interbody System with Titan nanoLOCK™ Surface Technology

## December 8th, 2022

| Submitter | Medtronic Sofamor Danek, USA Inc.<br>1800 Pyramid Place<br>Memphis, Tennessee 38132 |
|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Alex Underberg<br>Senior Regulatory Affairs Specialist<br>Email: [e-mail]<br>Telephone: [phone]<br>Fax: [phone] |
| Date Prepared | December 8th, 2022 |
| Name of Device | Catalyft™ LS Expandable Interbody System with Titan<br>nanoLOCK™ Surface Technology |
| 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): Catalyft™ LS Expandable<br>Interbody System (K212653, S.E. 11/19/2021)<br>Predicate 2: Anteralign LS™ Interbody System with Titan<br>nanoLOCK™ Surface Technology (K214010, S.E. 04/12/2022)<br>Predicate 3: Crescent™ PEEK (K094025, S.E. 04/26/2010;<br>K133216, S.E. 11/22/2013; K171031, S.E. 07/06/2017) |
| | 06/02/2010; K132897, S.E. 12/11/2013; K133577, 09/26/2014) |
| | Predicate 5: Elevate™ Spinal System (K142559, S.E. 06/09/2015) |
| | The Catalyft™ LS Expandable Interbody System with Titan<br>nanoLOCK™ Surface Technology consists of new interbody<br>implants that are provided sterile and are intended to be surgically<br>implanted between two lumbar or lumbosacral vertebral bodies to<br>give support and correction during lumbar intervertebral body<br>fusion. |
| Description | The Catalyft™ LS Expandable Interbody System with Titan<br>nanoLOCK™ Surface Technology is an expandable titanium alloy<br>interbody device consisting of expandable interbodies of various<br>widths, lengths, heights, and lordotic angles to accommodate<br>patient anatomy. These devices can be inserted between two<br>lumbar or lumbosacral vertebral bodies to give support and<br>correction during lumbar interbody fusion surgeries. Implants<br>have a central cavity that allows them to be packed with<br>autogenous bone graft and/or allograft bone graft comprised of<br>cancellous and/or corticocancellous bone, and/or demineralized<br>allograft bone with bone marrow aspirate. |
| | The interbody device is a line extension to add Titan<br>nanoLOCK™ Surface Technology to recently cleared Catalyft™<br>LS Expandable Interbody System (K212653, S.E. 11/19/2021).<br>The subject interbody incorporates Titan Surface Technologies™,<br>where superior and inferior surfaces include nanoLOCK™ surface<br>treatments designed to improve bone fixation to adjacent bone.<br>nanoLOCK™ surface technology provides a microscopic<br>roughened surface with nano-scale features. nanoLOCK Surface<br>Technology is specifically engineered to have nano textured<br>features at a nanometer (10-9) level, which has demonstrated the<br>ability to elicit an endogenous cellular and biochemical response<br>attributed to these nanotextured features <i>in vitro</i> . nanoLOCK<br>surface technology demonstrates elements to be considered<br>nanotechnology as outlined in the FDA nanotechnology guidance<br>document. |
| Indications for Use | The Catalyft™ LS Expandable Interbody System device,<br>including those with or without micro- and nano-roughened<br>surface textured features, is indicated for use as an<br>intervertebral body fusion device in skeletally mature patients<br>with degenerative disc disease (DDD - defined by discogenic<br>back pain with degeneration of the disc confirmed by patient<br>history and radiographic studies) at one or two contiguous<br>levels of the lumbar spine (L2-S1). Additionally, the<br>Catalyft™ LS Expandable Interbody System can be used with<br>patients diagnosed with multilevel degenerative scoliosis and<br>sagittal deformities as an adjunct to fusion. When used in<br>patients as an adjunct to fusion in patients diagnosed with<br>multilevel degenerative scoliosis and sagittal deformity<br>conditions, additional supplemental fixation (e.g. posterior<br>fixation) must be used. These patients should be skeletally<br>mature and have undergone 6 months of non-operative<br>treatment prior to surgery. Implants are used to facilitate fusion<br>in the lumbar spine using autogenous bone graft and/or<br>allograft bone graft comprised of cancellous and/or<br>corticocancellous bone, and/or demineralized allograft bone<br>with bone marrow aspirate.<br>These implants may be implanted via a variety of open or<br>minimally invasive anterior or oblique approach.<br>The Catalyft™ LS Expandable Interbody System device may<br>be used as a stand-alone device or in conjunction with<br>supplemental fixation. When used as a stand-alone device, the<br>Catalyft™ LS Expandable Interbody System device is<br>intended to be used with 4 titanium alloy screws. If the<br>physician chooses to use less than 4 or none of the provided<br>screws, additional supplemental fixation in the lumbar spine<br>must be used to augment stability. Implants with lordosis<br>angles greater than 20° are intended to be used with 4 screws<br>and supplemental fixation. |
| Comparison of<br>Technological<br>Characteristics with<br>the Predicate Devices | The subject device has the same or similar fundamental scientific<br>technology, indications for use, design, material, and levels of<br>attachment as the predicate devices. The subject device and<br>predicates are intended for stabilization use and to promote bone<br>fusion during the normal healing process following surgical<br>correction of disorders of the spine.<br>The subject interbody implant has an identical expansion<br>mechanism and size range as that of the primary predicate. |
| | The only difference between the subject device and the primary<br>predicate device is that the CatalyftTM LS nanoLOCKTM interbody<br>has Titan nanoLOCKTM Surface Technology. |
| Performance Data | The subject CatalyftTM LS nanoLOCKTM implants underwent the<br>following verification tests:<br>Static and Dynamic Compression per ASTM F2077-18 Static and Dynamic Compression Shear per ASTM F2077-<br>18 Subsidence per ASTM F2267-04(2018) Expulsion testing Wear Debris per ASTM F1877 (2016) MRI Safety Evaluation per ASTM 2503-20, ASTM<br>F2182-19e, ASTM 2052-21, F2213-17, F2219-07 |
| 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): CatalyftTM LS Expandable<br>Interbody System (K212653, S.E. 11/19/2021)<br>Predicate 2: Anteralign LSTM Interbody System with Titan<br>nanoLOCKTM Surface Technology (K214010, S.E. 04/12/2022)<br>Predicate 3: CrescentTM PEEK (K094025, S.E. 04/26/2010;<br>K133216, S.E. 11/22/2013; K171031, S.E. 07/06/2017)<br>Predicate 4: ClydesdaleTM Spinal System (K100175, S.E.<br>06/02/2010; K132897, S.E. 12/11/2013; K133577, 09/26/2014)<br>Predicate 5: ElevateTM Spinal System (K142559, S.E. 06/09/2015) |

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