The CoRoent Lumbar System (L and XL platforms) is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

Device Description

The NuVasive® CoRoent System is manufactured from PEEK-OPTIMA® Optima LT1 (Polyether-ether-ketone) conforming to ASTM standard F2026, Ti-6Al-4V ELI conforming to ASTM standard F136/1472 or Tantalum conforming to ASTM standard F560 or ISO 13782. These implants are available in a variety of shapes and configurations for PLIF/TLIF, XLIF and ALIF approaches, with heights ranging from 6 - 24 mm, widths ranging from 9 - 42 mm, lengths ranging from 20-65 mm and lordotic angles ranging from 0° - 20°, to suit the individual pathology and anatomical conditions of the patient. The hollow aperture allows for packing of autogenous bone graft. Teeth on the superior and inferior surface of the implants provide resistance to expulsion.

Both the subject device and its accessory surgical instruments are packaged as non-sterile, to be sterilized by the end user. In addition, the implants are also offered in sterile packaged versions.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the NuVasive® CoRoent® System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from predicate devices)	Reported Device Performance (NuVasive® CoRoent® System)
Static axial compression strength	Met the same criteria as predicate devices
Dynamic axial compression strength	Met the same criteria as predicate devices
Static compression shear strength	Met the same criteria as predicate devices
Dynamic compression shear strength	Met the same criteria as predicate devices
Resistance to subsidence	Met the same criteria as predicate devices
Mechanical integrity under various loads	Met the same criteria as predicate devices

2. Sample Size and Data Provenance

This information is not applicable as no human clinical data was used for this 510(k) submission. The performance data was based on nonclinical testing.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

This information is not applicable as ground truth related to human observation or clinical outcomes was not established for a test set in this submission. The "ground truth" for nonclinical testing would be the ASTM standards themselves and the inherent properties of the materials and design compared to predicate devices.

4. Adjudication Method (Test Set)

This information is not applicable as there was no human-reviewed test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case comparative effectiveness study was not done. The submission explicitly states, "No clinical studies were conducted."

6. Standalone (Algorithm Only) Performance Study

This information is not applicable as this is a medical device (intervertebral body fusion system) composed of physical materials, not an algorithm or software requiring standalone performance evaluation.

7. Type of Ground Truth Used

The ground truth used for demonstration of substantial equivalence was based on:

ASTM Standards: F2077 (for static and dynamic axial compression and compression shear) and F2267 (for subsidence testing). These established engineering standards serve as the "ground truth" for mechanical performance of intervertebral body fusion devices.
Predicate Device Performance: The "ground truth" was also implicitly derived from the established performance of legally marketed predicate devices. The NuVasive CoRoent System aimed to meet the same criteria as these already cleared devices.

8. Sample Size for the Training Set

This information is not applicable as there was no training set in the context of an algorithm or machine learning. The "training" in this context would be the design and engineering process to ensure the device met the specified ASTM standards and matched the characteristics of predicate devices.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there was no training set in the context of an algorithm or machine learning. The design and manufacturing process for the device was informed by material science, biomechanical engineering principles, and the performance characteristics of previously cleared predicate devices and established ASTM standards.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, layered on top of each other to create a sense of depth and unity. The profiles are rendered in a dark color, contrasting with the white background.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 13, 2015

NuVasive, Incorporated Mr. Jeremy Markovich Associate Manager, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121

Re: K141665

Trade/Device Name: NuVasive® CoRoent® System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: February 12, 2015 Received: February 13, 2015

Dear Mr. Markovich:

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 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{1}------------------------------------------------

Page 2 - Mr. Jeremy Markovich

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Lori A. Wiggins -S

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

Enclosure

{2}------------------------------------------------

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K141665

Device Name NuVasive® CoRoent® 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)
-----------------------------------------------------------------------------------------------------------------------------------------------------	----------------------------------------------------------------------------------------------------------------------------------------------------

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape in purple and gray, followed by the word "NUVASIVE" in gray, and the tagline "Speed of Innovation" in a smaller font below the company name. The logo is clean and modern, and the colors are muted and professional.

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.

Jeremy Markovich Associate Manager, Regulatory Affairs NuVasive, Inc. 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800

Date Prepared: February 12, 2015

B. Device Name

Trade or Proprietary Name:	NuVasive® CoRoent® System
Common or Usual Name:	Intervertebral Body Fusion Device
Classification Name:	Intervertebral Body Fusion Device with Bone Graft, Lumba

Device Class:	Class II
Classification:	21 CFR § 888.3080
Product Code:	MAX

C. Predicate Devices

The subject CoRoent System is substantially equivalent to the primary predicate device, NuVasive CoRoent System (K071795), and the following additional predicate devices: Depuy Cougar Implant System (K113348), NuVasive CoRoent Titanium System (K120918), NuVasive Brigade Hyperlordotic System (K123045), NuVasive Expandable Lumbar Interbody System (K130820), InterForm Interbody Cage System (K131082), NuVasive CoRoent XL Sterile Implants (K132601), Alphatec Novel Spinal Spacer System (K080699), NuVasive CoRoent Ti-C System (K140319), Pioneer Surgical Technology, Inc. Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System (K133455), Stryker Spine AVS PL PEEK Spacers (K090816), and Globus Medical Inc. Caliber Spacers (K123231).

D. Device Description

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image is a logo for Nuvasive. The logo features a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray, and the words "Speed of Innovation" in a smaller font below. The logo is simple and modern, and the colors are eye-catching.

Both the subject device and its accessory surgical instruments are packaged as non-sterile, to be sterilized by the end user. In addition, the implants are also offered in sterile packaged versions.

E. Intended Use

The NuVasive CoRoent Lumbar System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. Patients with previous non-fusion spinal surgery at involved level may be treated with the device. The devices are to be used in patients who have had at least six months of non-operative treatment. The CoRoent Lumbar System (L and XL platforms) is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

F. Technological Characteristics

As was established in this submission, the subject CoRoent System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United The subject device was shown to be substantially equivalent and have the same States. technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and function. This device does not contain software or electrical equipment.

G. Performance Data

Nonclinical testing was performed to demonstrate that the subject CoRoent System is substantially equivalent to other predicate devices. The following testing was performed:

Static and dynamic axial compression and compression shear per ASTM F2077
Finite Element Analysis ●
. Subsidence testing and analysis per ASTM F2267

The results demonstrate that the subject CoRoent System meets the same criteria as the predicate devices, and the subject device was therefore found to be substantially equivalent to the predicate. No clinical studies were conducted.

H. Conclusions

Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject CoRoent System has 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.