The TM-400 device is a Vertebral Body Replacement device intended for use in the thoracolumbar spine (T1 – L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The TM-400 device is intended for use with supplemental internal fixation systems, and may be used with autograft or allograft.

The TM-400 device is also intended for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. The TM-400 device is intended for use with supplemental internal fixation and autogenous bone graft.

Device Description

The TM-400 Device is an oval shaped ALIF device for interbody fusion of the anterior column of the spine. The TM-400 Device is currently cleared to accommodate the replacement of a vertebral body in the thoracic and lumbar region of the spine. Use of this device is expanded to include use as an interbody fusion device. TM-400 Device is designed for fusing the adjacent bony surfaces and may be used to replace a disc at one or two contiguous levels in L2-S1. The device is available in a variety of cross sections and heights to accommodate variations in the individual pathology and anatomic condition of the patient. TM-400 implants are also available in two lordotic angles 7 degree and 13 degree. The superior and inferior surfaces of the device contain a pattern of teeth to provide for initial stability. The device also has slots to mate with the insertion instrument. The TM-400 device is wholly comprised of Trabecular Metal Porous Tantalum. Surgical instrumentation for use with the proposed system are fabricated from surgical grade stainless steel and other applicable materials.

AI/ML Overview

The provided text is a 510(k) summary for the Zimmer Trabecular Metal Technology, Inc. TM-400 Device. This document describes a medical device and its equivalence to predicate devices, focusing on its mechanical performance rather than AI/software performance. Therefore, most of the requested information regarding AI study design and performance criteria is not applicable.

Here's the information that can be extracted or that is not applicable, based on the document:

Acceptance Criteria and Device Performance

This document describes a medical device (an intervertebral body fusion device), not an AI/software device. The "acceptance criteria" discussed are related to the mechanical performance of the physical implant, rather than the performance of an algorithm. The study described is mechanical testing, not a clinical or AI performance study.

Acceptance Criteria (from FDA Guidance Document)	Reported Device Performance (from mechanical testing)
Static Axial Compression (ASTM F2077-03)	Adequately meets predetermined requirements
Dynamic Axial Compression (ASTM F2077-03)	Adequately meets predetermined requirements
Static Torsion (ASTM F2077-01)	Adequately meets predetermined requirements
Dynamic Torsion (ASTM F2077-01)	Adequately meets predetermined requirements
Expulsion (N/R)	Adequately meets predetermined requirements
Subsidence (ASTM F2267-04 & F2077)	Adequately meets predetermined requirements

Note: The document states that "The results of testing and analyses conducted demonstrate that the proposed system adequately meets the predetermined requirements established for its mechanical performance." Specific numerical performance data for these tests (e.g., actual compression load, torsion values) are not provided in this summary.

Study Details (for AI/Software - Not Applicable Here)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. This is not an AI/software device, and there is no test set of data as would be used for an AI algorithm. The "test set" here refers to physical samples of the device undergoing mechanical stress tests in a lab.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. Ground truth, in the context of expert consensus, is not relevant for mechanical testing of a physical implant. The "ground truth" for mechanical performance would be the physical properties as measured by scientific instruments following standardized test methods.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are used in clinical studies or for establishing ground truth from expert opinions, which is not relevant for mechanical testing.
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:
- Not Applicable. This is not an AI-assisted device, so no MRMC study involving human readers and AI was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. The "ground truth" for the device's mechanical performance is derived from the results of standardized mechanical tests (ASTM standards) in a laboratory setting, not from expert consensus, pathology, or outcomes data in the traditional sense.
The sample size for the training set:
- Not Applicable. There is no training set as this is not an AI/machine learning device.
How the ground truth for the training set was established:
- Not Applicable. There is no training set for this device.

Summary

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JUN 1 5 2012

510(k) Summary

Submitter:	Zimmer Trabecular Metal Technology, Inc.10 Pomeroy RoadParsippany, New Jersey 07054
Contact Person:	Kathleen RutherfordAssociate Director, Regulatory AffairsTelephone: (973) 576-0139Fax: (973) 884-8792
Date:	June 6, 2012
Trade Name:	TM-400 Device
Common Name:ReplacementClassification Name:	Intervertebral body fusion device & Spinal Vertebral BodyDeviceIntervertebral body fusion device, 21 CFR § 888.3080,Spinal intervertebral body fixation orthosis, 21 CFR § 888.3060

Device Panel/Product Code:Orthopedic MAX & MQP

Device Description:

Indications for Use:

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disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. The TM-400 device is intended for use with supplemental internal fixation and autogenous bone graft.

Device Technological Characteristics and Comparison to Predicate Device(s):

The TM-400 Device was shown to be substantially equivalent to legally marketed predicate devices. The predicate devices include this TM-400 Device as a VBR (K052950, K031823, K010378 and, for the instrumentation, K093127), the Zimmer Spine, Inc. Ardis® Interbody System cleared under K073202, the Biomet Enclave cleared under K081636 and the Orthofix Pillar AL cleared under K082235.

The TM-400 Device has the identical material as previously cleared devices. The intended use and indications for use of the subject device are similar to those of its predicate devices. The sizes, design features and overall geometry of the device in the current submission are similar to the cleared predicate devices.

There are no significant differences between the TM-400 Device and the predicate devices currently being marketed that would adversely affect the use of the product. Any differences in technological characteristics do not raise new issues of safety or efficacy. The subject system is similar to its predicate devices with respect to intended use/indications for use, material, technological characteristics and basic principles of operation.

Performance Data:

Mechanical testing was performed on the TM-400 Device as recommended by the FDA Class II Special Controls Guidance Document: Intervertebral Fusion Device. The tests that were performed and the relevant ASTM Standards are as follows:

Mechanical Tests	ASTM Standard
Static Axial Compression	F2077-03
Dynamic Axial Compression	F2077-03
Static Torsion	F2077-01
Dynamic Torsion	F2077-01
Expulsion	N/R
Subsidence	F2267-04 & F2077

The results of testing and analyses conducted demonstrate that the proposed system adequately meets the predetermined requirements established for its mechanical performance.

Substantial Equivalence:

The TM-400 Device is substantially equivalent to its predicate devices with respect to intended use/indications for use, materials, technological characteristics and basic principles of operation as demonstrated by the supporting performance testing data.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features 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 fashion around the symbol.

Public Health Service

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

JUN 1 5 2012

Zimmer Trabecular Metal Technology, Inc. % Ms. Kathleen Rutherford Associate Director, Regulatory Affairs 10 Pomeroy Road Parsippany, New Jersey 07054

Re: K120203

Trade/Device Name: TM-400 Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MQP Dated: May 21, 2012 Received: May 29, 2012

Dear Ms. Rutherford:

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

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Page 2 - Ms. Kathleen Rutherford

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,

Mark McMillan

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): ____________________________________________________________________________________________________________________________________________________

Device Name: TM-400 Device

Indications for Use:

The TM-400 device is a Vertebral Body Replacement device intended for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The TM-400 device is intended for use with supplemental internal fixation systems, and may be used with autograft or allograft.

The TM-400 device is also intended for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-SI. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. The TM-400 device is intended for use with supplemental internal fixation and autogenous bone graft.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

K120203 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.