The NuVasive MLX - Medial Lateral Expandable Lumbar Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The used in patients who have had at least six months of non-operative treatment.

The NuVasive MLX- Medial Lateral Expandable Lumbar Interded for use in interded for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The NuVasive MLX- Medial Lateral Expandable Lumbar Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

The NuVasive AP Expandable XLIF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems (e.g., pedicle screw/rod systems) cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.

The NuVasive AP Expandable XLIF System is intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The NuVasive AP Expandable XLIF System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scollosis.

Device Description

The NuVasive MLX and APX Interbody Devices are manufactured from Ti-6Al-4V ELI conforming to ASTM F136 and ISO 5832-3, Ti-6A1-4V conforming to ASTM 1472, and Nitinol SE508 conforming to ASTM F2063. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. This scope of this 510(k) includes expanded indications for use and minor add-to-file changes.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding the NuVasive MLX - Medial Lateral Expandable Lumbar Interbody System and the NuVasive AP Expandable XLIF System. It determines these devices are substantially equivalent to legally marketed predicate devices.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

Table of Acceptance Criteria and Reported Device Performance:

The document does not provide explicit acceptance criteria or reported device performance metrics in the format of a typical performance study. Instead, it relies on demonstrating "substantial equivalence" to predicate devices. This means that if the predicate devices meet performance requirements, and the new device is sufficiently similar, it can be marketed.

The performance data mentioned pertains to mechanical testing and bacterial endotoxin testing.

Acceptance Criteria Category/Type	Reported Device Performance/Testing
Mechanical Performance	"Mechanical performance testing data was provided as part of the previous submissions to establish substantial equivalence for their use. The previously presented mechanical testing data are sufficient to support the subject system and does not warrant the need for additional nonclinical testing." (Referencing K153105 and K140162 for specific data)
Biocompatibility/Bacterial Endotoxin	"Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST72:2011/(R)2016." (No specific pass/fail values or results are explicitly stated in this summary, but the implication is that it passed the standard.)

Sample size used for the test set and the data provenance:

Since no new clinical or performance study was conducted for this specific 510(k) submission (K173025) beyond referencing prior submissions, there is no new test set sample size or data provenance provided in this document. The mechanical testing data relies on previous submissions (K153105 and K140162), and the bacterial endotoxin testing would typically be performed on a representative sample of manufactured devices.
The document does not specify country of origin for any data cited from previous submissions, nor whether it was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No new clinical or comparative performance study with an expert-established ground truth was conducted for this submission. The ground truth for interbody fusion devices in a 510(k) context often relates to demonstrating material properties, mechanical integrity, and biocompatibility, rather than diagnostic accuracy that would require expert consensus on cases.
Adjudication method for the test set:

Not applicable. No new clinical study requiring adjudication of a test set was conducted for this submission.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is an intervertebral body fusion device, not a diagnostic or AI-assisted imaging device. Therefore, MRMC studies are not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical implant, not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the mechanical and bacterial endotoxin testing, the "ground truth" would be established by:
- Mechanical Testing: Adherence to established engineering and biomechanical standards (e.g., ISO, ASTM) for strength, durability, and fatigue life of interbody fusion devices. The ground truth is the device's ability to withstand physiological loads and maintain structural integrity.
- Bacterial Endotoxin Testing: Compliance with the ANSI/AAMI ST72:2011/(R)2016 standard, which sets limits for endotoxin levels to ensure the device is not pyrogenic.
The sample size for the training set:

Not applicable. This is not an AI/ML device requiring a training set.
How the ground truth for the training set was established:

Not applicable. This is not an AI/ML device requiring ground truth for a training set.

In summary:

This 510(k) notification for the NuVasive MLX and APX systems relies on demonstrating substantial equivalence to previously cleared devices rather than providing a new, comprehensive performance study with explicit acceptance criteria and device performance results. The core of the evidence lies in the technological characteristics, materials, and intended use being similar to existing, legally marketed devices, and referencing prior mechanical test data and current bacterial endotoxin testing to support safety and effectiveness.

Summary

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February 8, 2018

NuVasive, Incorporated Cynthia Adams Sr. Specialist, Regulatory Affairs 7475 Lusk Blvd. San Diego, California 92121

Re: K173025

Trade/Device Name: NuVasive® MLX® - Medial Lateral Expandable Lumbar Interbody System, NuVasive® AP Expandable XLIF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, PHM Dated: January 8, 2018 Received: January 9, 2018

Dear Ms. Adams:

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. 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 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Katherine D. Kavlock -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K173025

Device Name

NuVasive® MLX® - Medial Lateral Expandable Lumbar Interbody System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K173025

Device Name

NuVasive® AP Expandable XLIF System

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:

Submitted by: A.

Cynthia Adams Senior Specialist, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800

Date Prepared: January 8, 2018

B. Device Name

Trade or Proprietary Name:	NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System NuVasive® AP Expandable XLIF System
Common or Usual Name:	Intervertebral Body Fusion Device
Classification Name:	Intervertebral Body Fusion Device;
Device Class:	Class II
Classification:	21 CFR § 888.3080
Product Code:	MAX, PHM

Predicate Devices C.

The subject NuVasive MLX and APX Interbody Devices are substantially equivalent to the primary predicate device, CoRoent Thoracolumbar System (K170962) and additional predicate devices, NuVasive® MLX™ – Medial Lateral Expandable Lumbar Interbody System (K153105) and AP Expandable XLIF System (K140162).

D. Device Description

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K173025
Page 2 of 3

Indications for Use E.

The NuVasive MLX- Medial Lateral Expandable Lumbar Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.

The NuVasive MLX- Medial Lateral Expandable Lumbar Interbody System is intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The NuVasive MLX- Medial Lateral Expandable Lumbar Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

The NuVasive AP Expandable XLIF System is intended for use in interbody fusions in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), and is intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The NuVasive AP Expandable XLIF System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

F. Technological Characteristics

As was established in this submission, the subject NuVasive MLX and APX Interbody Devices are substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject devices were shown to be substantially equivalent and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, function and sterilization method.

G. Performance Data

Mechanical performance testing data was provided as part of the previous submissions to establish substantial equivalence for their use. The previously presented mechanical testing data are sufficient to support the subject system and does not warrant the need for additional nonclinical testing. Therefore, no new mechanical testing was performed for this 510(k) submission.

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K173025	Page 3 of 3
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Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST72:2011/(R)2016.

H. Conclusions

Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject NuVasive MLX and APX Interbody Devices have been shown to be substantially equivalent to legally marketed predicate devices.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
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.(b)
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.