The CoRoent No-Profile System is a standalone system indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous nonfusion spinal surgery at the involved level(s). The CoRoent No-Profile System is intended for use with autograft.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the CoRoent No-Profile System.

Device Description

The NuVasive CoRoent No-Profile Standalone System is manufactured from PEEK-Optima LT1, titanium alloy, and Nitinol SE508 alloy. The implants are available in a variety of sizes to suite the individual pathology and anatomical conditions of the patient. The CoRoent No-Profile Standalone System is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.

AI/ML Overview

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Acceptance Criteria and Study Details for NuVasive CoRoent No-Profile System

This document describes the premarket notification (510(k)) for the NuVasive CoRoent No-Profile System. The "acceptance criteria" here refer to demonstrating substantial equivalence to predicate devices through
various nonclinical performance tests, rather than a clinical study with statistical endpoints.

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Testing	Must be comparable to predicate devices to demonstrate safe and effective performance for intended use.	Passed All Tests: Results demonstrated substantial equivalence to predicate devices.
Static Axial Compression	ASTM F2077-03 Compliance	Performed per ASTM F2077-03; results indicate equivalence.
Dynamic Axial Compression	ASTM F2077-03 Compliance	Performed per ASTM F2077-03; results indicate equivalence.
Static Torsion	ASTM F2077-03 Compliance	Performed per ASTM F2077-03; results indicate equivalence.
Dynamic Torsion	ASTM F2077-03 Compliance	Performed per ASTM F2077-03; results indicate equivalence.
Expulsion	Compliance with Draft standard, work item Z8423Z	Performed per Draft standard Z8423Z; results indicate equivalence.
Subsidence	ASTM F2267-04 Compliance	Performed per ASTM F2267-04; results indicate equivalence.
Wear Debris	ASTM F2077 & ASTM F17877 Compliance	Performed per ASTM F2077 & ASTM F17877; results indicate equivalence.
Axial Screw Pullout	ASTM F543 Compliance	Performed per ASTM F543; results indicate equivalence.
Screw Push-out Testing	Implied standard for screw retention	Performed; results indicate equivalence.
Screw Push-through Testing	Implied standard for screw retention	Performed; results indicate equivalence.
Static Separation Testing	Implied standard for construct integrity	Performed; results indicate equivalence.

Note: The document explicitly states: "The results of these studies, as well as the descriptive information presented, demonstrates that the subject CoRoent No-Profile System is substantially equivalent to the performance of the predicate devices, and the device was therefore found to be substantially equivalent."

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

The study described is focused on nonclinical performance testing of a medical device, not a human clinical trial. Therefore, the concept of a "test set" in the context of human subjects or data provenance (e.g., country of origin, retrospective/prospective) does not apply here. The "test sets" would refer to the physical samples of the device components manufactured and tested in a laboratory setting. The document does not specify the exact number of physical samples used for each nonclinical test, but it implies a sufficient number were used to meet the requirements of the specified ASTM standards and draft work items.

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

This section is not applicable as the study is a nonclinical, mechanical performance evaluation of a device, not a diagnostic or clinical study requiring expert ground truth assessment.

4. Adjudication Method for the Test Set

This section is not applicable as the adjudication method is relevant for expert review in clinical or diagnostic studies. Nonclinical performance testing results are typically evaluated against predefined engineering specifications.

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

This section is not applicable as the submission is for a medical device (spinal implant) and not an imaging or diagnostic AI system that would typically undergo an MRMC study.

6. Standalone (Algorithm Only) Performance

This section is not applicable as the submission is for a physical medical device (spinal implant), not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for this nonclinical study is the established performance criteria and specifications defined by the relevant ASTM standards (e.g., ASTM F2077-03, ASTM F2267-04, ASTM F543, ASTM F17877) and a draft standard (Z8423Z). The device's performance was compared to these benchmarks and to the known performance characteristics of the predicate devices.

8. Sample Size for the Training Set

This section is not applicable as this is a nonclinical device performance study, not a machine learning model, and therefore has no "training set."

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

This section is not applicable for the same reason as above.

Summary

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MAR 1 3 2012

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Special 510(k) Premarket Notification CoRoent No-Profile 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:

A. Submitted by:

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: September 1, 2011

B. Device Name

Trade or Proprietary Name:	NuVasive CoRoent® No-Profile System
Common or Usual Name:	Intervertebral Body Fusion Device
Classification Name:	Intervertebral Body Fusion Device

Device Class:	Class II
Classification:	21 CRF §888.3080
Product Code:	MAX, OVD

C. Predicate Devices

The subject NuVasive CoRoent No-Profile System is substantially equivalent to the following device:

510(k) Number	Product Name
K100043	NuVasive CoRoent XLR Standalone System
K102090	SpineSmith Cynch Spinal System – Visualif Interbody FusionImplant System
K041617,K073109	SurgiCraft STALIFTM TT Intervertebral Body Fusion System
K091301	Life Spine® Stand-Alone Spacer System (Dyna-Link®)
K082252	Globus Medical Independence® Spacer

D. Device Description

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E. Intended Use

The CoRoent No-Profile System is a standalone system indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved level(s). The CoRoent No-Profile System is intended for use with autograft.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the CoRoent No-Profile System.

F. Technological Characteristics

As was established in this submission, the subject CoRoent No-Profile 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, function, and range of sizes.

G. Performance Data

Nonclinical testing was performed to demonstrate that the subject CoRoent No-Profile System is substantially equivalent to other predicate devices. The following testing was performed:

Static & Dynamic Axial Compression testing per ASTM F2077-03 .
Static & Dynamic Torsion testing per ASTM F2077-03 ●
Expulsion testing per Draft standard, work item Z8423Z .
Subsidence testing per ASTM F2267-04 .
Wear Debris per ASTM F2077 & ASTM F17877 .
Axial Screw Pullout per ASTM F543 .
Screw Push-out Testing .
Screw Push-through Testing t
Static Separation Testing .

The results of these studies, as well as the descriptive information presented, demonstrates that the subject CoRoent No-Profile System is substantially equivalent to the performance of the predicate devices, and the device was therefore found to be substantially equivalent.

H. Conclusions

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject CoRoent No-Profile 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

MAR 1 3 2012

Re: Ki12561

Trade/Device Name: NuVasive CoRoent No-Profile System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MAX Dated: February 10, 2012 Received: February 13, 2012

Dear Ms. Bruschi:

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

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Page 2 - Ms. Sheila Bruschi

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Grice-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/CDRH/CDRHOffices/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 100.97). 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,

Mark N. Molkerson

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): K112561

Device Name:

Indications For Use:

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the CoRoent No-Profile System.

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)

Division Sign Off

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

K 11256 ( 510(k) Number_

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.