The NuVasive CoRoent Lumbar System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The implants are designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation system cleared by the FDA for use in the lumbar spine. 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) are intended for use at either one level or two contiguous levels in the lumbar spine, from L1-L2 to L5-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. Additionally, the CoRoent Lumbar System (L and XL platforms) can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

Device Description

The CoRoent Lumbar System is manufactured from PEEK-Optima® LT-1 conforming to ASTM F2026 or titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The PEEK device contains radiographic markers manufactured from titanium alloy conforming to ASTM F136 or ASTM F1472. The implants are available in a variety of different shapes and sizes 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. The device is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine. The purpose of this 510(k) is to expand the indications for use of previously cleared CoRoent Lumbar implants for use in patients with degenerative scoliosis.

AI/ML Overview

This document is a 510(k) Summary for the NuVasive® CoRoent® Lumbar System. It seeks to expand the indications for use of previously cleared implants. The information provided in the document does not include a study to prove the device meets acceptance criteria, but rather asserts substantial equivalence to existing predicate devices.

Therefore, the following information cannot be extracted from the provided text:

Table of acceptance criteria and the reported device performance: This document does not specify any performance-based acceptance criteria or provide performance data for the device. Instead, it relies on substantial equivalence to predicate devices.
Sample size used for the test set and the data provenance: Since no performance study is described, there's no test set, sample size, or data provenance mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a test set is mentioned.
Adjudication method for the test set: No adjudication method is mentioned as there is no test set or study described.
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: No MRMC study or AI component is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance is mentioned.
The type of ground truth used: No ground truth is mentioned in the context of a performance study.
The sample size for the training set: No training set is mentioned.
How the ground truth for the training set was established: No ground truth for a training set is mentioned.

Key takeaway from the document:

Substantial Equivalence: The NuVasive CoRoent Lumbar System is deemed substantially equivalent to the primary predicate device, NuVasive CoRoent System (K141896), and additional predicate NuVasive CoRoent System (K141665).
No Performance Data: The document explicitly states: "No performance data was provided to demonstrate that the subject NuVasive CoRoent Lumbar System is substantially equivalent to the predicate devices."
Basis of Equivalence: The substantial equivalence is based on technological characteristics and comparison to predicate devices, specifically in areas including design, labeling/intended use, material composition, and function, with an emphasis that "There have been no design changes to the implants previously cleared in the predicate 510(k)s."
Purpose: The purpose of this 510(k) is to expand the indications for use of previously cleared CoRoent Lumbar implants for use in patients with degenerative scoliosis.

Summary

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

September 10, 2015

NuVasive, Incorporated Martin A. Yahiro, M.D. Director, Medical Affairs 7475 Lusk Boulevard San Diego, California 92121

Re: K151472

Trade/Device Name: NuVasive® CoRoent® Lumbar Sytem Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 15, 2015 Received: June 16, 2015

Dear Dr. Yahiro:

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

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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 yours,

Mark N. Melkerson -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration
Indications for Use	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.

510(k) Number (if known)	K151472
Device Name	NuVasive® CoRoent® Lumbar System
Indications for Use (Describe)	The NuVasive CoRoent Lumbar System is indicated for intervertebral body fusion of the spine in skeletally maturepatients. The implants are designed for use with autogenous bone graft to facilitate fusion and supplemental internalspinal fixation system cleared by the FDA for use in the lumbar spine. The devices are to be used in patients who havehad at least six months of non-operative treatment.
	The CoRoent Lumbar System (L and XL platforms) are intended for use at either one level or two contiguous levels in thelumbar spine, from L1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) with up to Grade Ispondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by historyand radiographic studies. Additionally, the CoRoent Lumbar System (L and XL platforms) can be used as an adjunct tofusion in patients diagnosed with degenerative scoliosis.

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)

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r and states of the state of the comment of the comment of the

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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:

A. Submitted by:

Martin Yahiro, M.D. Director, Medical Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800

Date Prepared: September 4, 2015

B. Device Name

Trade or Proprietary Name:	NuVasive® CoRoent® Lumbar 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

C. Predicate Devices

The subject NuVasive CoRoent Lumbar System is substantially equivalent to the primary predicate device, NuVasive CoRoent System (K141896) and additional predicate NuVasive CoRoent System (K141665).

D. Device Description

E. Indications for Use

The NuVasive® CoRoent Lumbar System is indicated for the following:

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Technological Characteristics F.

As was established in this submission, the subject NuVasive CoRoent Lumbar System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. There have been no design changes to the implants previously cleared in the predicate 510(k)s. The subject device was shown to be substantially equivalent and have equivalent technological characteristics to its predicate device through comparison in areas including design, labeling/intended use, material composition, and function.

G. Performance Data

No performance data was provided to demonstrate that the subject NuVasive CoRoent Lumbar System is substantially equivalent to the predicate devices.

H. Conclusions

Based on the technological characteristics and comparison to predicate devices, the subject NuVasive CoRoent Lumbar 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.