When used as a cervical intervertebral body fusion device, the Zavation IBF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (definded as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.

When used as a lumbar intervertebral body fusion device, the Zavation IBF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are 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 lumbar device is intended to be used in patients who have had six months of non-operative treatment.

For all the above indications the Zavation IBF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Spinal System and Zavation Cervical Plate System.

Device Description

The Zavation IBF implants offers a variety of heights, widths and lengths. There are six main configurations: ALIF, LLIF, T-PLIF, PLIF and CIF. The different configurations allow for multiple surgical technique options. The implants are manufactured from medical grade PEEK (Polyetheretherketone).

The Zavation IBF implants are available in a range of sizes, as well as parallel and lordotic angled implants, to accommodate variations in patients' anatomy. In addition, tantalum beads or pins are embedded in the implants as an option to help allow for radiographic visualization. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
No new worst-case device.	Finite element analysis demonstrated that added components would not result in a new worst-case device.
Substantial equivalence to predicate devices (K112664 and K091088).	Results from finite element analysis demonstrated that the subject devices are substantially equivalent to the referenced predicates.
Compliance with ASTM F2077 (for FEA validation).	Finite element analysis method has been validated to testing performed per ASTM F2077.

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

The provided text does not mention a test set in the traditional sense of a clinical or observational study with human participants. The "test" here refers to the validation of a computational method.

Sample size for the test set: Not applicable, as detailed above.
Data provenance: Not applicable. The "study" is a finite element analysis, meaning it's a computational simulation rather than an empirical study gathering data from a specific population or geographic region.

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

There's no mention of experts establishing ground truth for a test set in this context.

Ground truth in this study: The "ground truth" for the finite element analysis (FEA) is the established engineering principles and material properties used in the simulation, and its validation against testing performed per ASTM F2077. This is a technical standard rather than an expert consensus.

4. Adjudication Method for the Test Set

Not applicable. There was no expert adjudication process mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This submission concerns an intervertebral body fusion device, not an AI-powered diagnostic or interpretive system that would involve human readers.

6. 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.

7. The Type of Ground Truth Used

The "ground truth" for this engineering analysis is based on established engineering principles, material properties (PEEK Zeniva ZA-500, Tantalum alloy), and validation against a recognized industry standard (ASTM F2077). It is not an expert consensus, pathology, or outcomes data in the biological sense. The outcome of the FEA is whether the new configurations maintain mechanical integrity and don't create a "new worst-case device" compared to the predicates.

8. The Sample Size for the Training Set

Not applicable. This is an engineering analysis of a physical device, not a machine learning model requiring a training set.

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

Not applicable. As above, there is no training set in this context.

Summary

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MAR 2 8. 2012

510K Summary

Date:

Submitter:

March 27, 2012

Zavation LLC 501 Avalon Way Brandon, MS 39047 Phone: 601-919-1119 Fax: 800-447-1302

Contact person:

John Walker

Special

Type of 510(k) submission:

Trade name:

Common name:

Intervertebral Body Fusion Device

888.3080 (MAX, ODP)

Zavation IBF System

Classification regulation:

Device classification: Class II

Classification Panel: Orthopedic

Product code: MAX, ODP

Purpose of Submission:

The purpose of this Special 510(k) is to add additional footprint sizes and lordotic angles to the Zavation CIF cage.

Device Description:

Intended Use:

When used as a cervical intervertebral body fusion device, the Zavation IBF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature

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patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T 1, for the treatment of cervical disc disease (definded as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.

Materials:

The devices are manufactured from medical grade PEEK Zeniva ZA-500(ASTM F2026) with Tantalum alloy position markers (ASTM F560).

Predicate Device:

Zavation IBF System, Zavation LLC (K112664) LDR Spine Cervical Interbody Fusion System (K091088)

Technological Characteristics:

The Zavation IBF System possesses the same technological characteristics as the predicates. These include similar heights, widths, lengths, and intended use.

Performance Data:

Finite element analysis was performed to demonstrate that the components added to the Zavation IBF System in this 510(k) submission would not result in a new worst-case device. The finite element analysis method has been validated to testing performed per ASTM F2077. Results from this analysis demonstrates that the subject devices are substantially equivalent to the referenced predicates.

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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 caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.

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

MAR 2 8 2012

Zavation LLC % Mr. John Walker 501 Avalon Way Brandon, Mississippi 39047

Re: K120576

Trade/Device Name: Zavation IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP Dated: February 24, 2012 Received: February 27, 2012

Dear Mr. Walker:

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 - Mr. John Walker

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/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 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,

Euinell Keith

/ 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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Attachment 3 - Indications for Use Statement

Indications for Use

510(k) Number: KI 20576

Device Name: Zavation IBF System

Indications For Use:

For all the above indications the Zavation IBF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Pedicle Screw System and Zavation Cervical Plate System.

Prescription Use _ X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

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

KI20576 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.