The NuVasive CoRoent Titanium 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. The CoRoent Titanium System 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. The devices are to be used in patients who have had at least six months of non-operative treatment. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

Partial Vertebral Body Replacement

The NuVasive CoRoent Titanium System may also be used as a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.

Device Description

The NuVasive CoRoent Titanium System is a lumbar interbody system manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or ISO 5832-3. The implants are available in a variety of sizes to suite the individual pathology and anatomical conditions of the patient. 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.

AI/ML Overview

The NuVasive CoRoent Titanium System is an intervertebral body fusion device and partial vertebral body replacement device. This 510(k) summary indicates that the device met acceptance criteria through Finite Element Analysis (FEA), which demonstrated its substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from FEA)	Reported Device Performance (FEA Results)
Axial Compression	No new worst-case for performance testing compared to predicate.
Compression Shear	No new worst-case for performance testing compared to predicate.
Torsion	No new worst-case for performance testing compared to predicate.
Subsidence	No new worst-case for performance testing compared to predicate.

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is a Finite Element Analysis (FEA).

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a "test set" in the context of clinical or image-based data. Instead, the performance evaluation was based on Finite Element Analysis (FEA). FEA is a computational method that discretizes a structure into many small elements to analyze its behavior under various loads. The "sample size" for this type of analysis refers to the complexity of the model (e.g., number of elements, nodes) rather than a cohort of patients or images. The document does not provide details on the specific FEA model parameters or the provenance of any physical data used to validate the FEA model, if applicable.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not applicable as the study described is a Finite Element Analysis (FEA) of the device's mechanical properties, not a study involving human interpretation of medical data where "ground truth" would be established by experts.

4. Adjudication Method for the Test Set:

This information is not applicable as the performance data is derived from Finite Element Analysis (FEA), which is a computational simulation, not a review process requiring human adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The performance data provided is based on Finite Element Analysis (FEA) of the device itself, not a study of human readers' performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The performance study described is a standalone evaluation of the device's mechanical properties through Finite Element Analysis (FEA). This is an "algorithm only" in the sense that it's a computational simulation of the device's behavior, without human intervention in the performance measurement itself (though humans design the FEA and interpret its results).

7. The Type of Ground Truth Used:

The "ground truth" in this context refers to the engineering principles and material properties that govern the behavior of the titanium alloy (Ti-6Al-4V) used in the device. The FEA simulates these physical laws to predict performance. There is no biological or clinical "ground truth" derived from pathology or outcomes data presented for this specific performance evaluation.

8. The Sample Size for the Training Set:

This information is not applicable. Finite Element Analysis (FEA) is a simulation method based on physical laws and material properties, not a machine learning model that requires a "training set" of data.

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

This information is not applicable as there is no "training set" in the context of a Finite Element Analysis (FEA). The "ground truth" for FEA is based on established physics, material science, and engineering standards.

Summary

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JUN 28 2012

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510(k) Premarket Notification CoRoent Titanium System

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.

Sheila Bruschi Associate Manager, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 320-4515 Fax: (858) 320-4615

Date Prepared: March 23, 2012

B. Device Name

Trade or Proprietary Name:	NuVasive CoRoent ® Titanium System
Common or Usual Name:	Intervertebral Body Fusion Device,Spinal Vertebral Body Replacement Device
Classification Name:	Intervertebral Body Fusion Device,Spinal Vertebral Body Replacement Device

Device Class:	Class II
Classification:	21 CFR § 888.3060, § 888.3080
Product Code:	MAX, MQP

C. Predicate Devices

The subject NuVasive CoRoent Titanium System is substantially equivalent to the following predicate device: NuVasive CoRoent System (K071795)

D. Device Description

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510{k} Premarket Notification CoRoent Titanium System

E. Intended Use

Intervertebral Body Fusion

Partial Vertebral Body Replacement

F. Technological Characteristics

As was established in this submission, the subject CoRoent Titanium System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was 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, and function.

G. Performance Data

Finite Element Analysis (FEA) was performed to demonstrate that the subject CoRoent Titanium System is substantially equivalent to other predicate devices for the following:

Axial Compression ●
Compression Shear ●
Torsion . ●
Subsidence .

The results demonstrate that the subject CoRoent Titanium System presents no new worstcase for performance testing, and the subject device was therefore found to be substantially equivalent to the predicate.

H. Conclusions

Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject CoRoent Titanium System has been shown to be substantially equivalent to legally marketed predicate devices, and safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The text is in all caps and appears to be in a sans-serif font.

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

JUN 2 8 2012

NuVasive, Inc. % Ms. Sheila Bruschi Associate Manager, Regulatory Affairs 7475 Lusk Blvd. San Diego, California 92121

Re: K120918

Trade/Device Name: NuVasive CoRoent® Titanium System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MQP Dated: June 6, 2012 Received: June 7, 2012

Dear Ms. Bruschi:

We have reviewed vour 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.

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Page 2 - Ms. Sheila Bruschi

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours.

Sincerely yours,

for
Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

NuVasive® CoRoent® Titanium System Device Name:

Indications For Use:

Intervertebral Body Fusion

Partial Vertebral Body Replacement

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Diysson Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

K120918 510(k) Number_

Page 1 of 1

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.