TEZO TITANIUM CAGE FAMILY

K122957 · Ulrich GmbH & Co. KG · MAX · Jun 21, 2013 · Orthopedic

Device Facts

• Record ID: K122957
• Device Name: TEZO TITANIUM CAGE FAMILY
• Applicant: Ulrich GmbH & Co. KG
• Product Code: MAX · Orthopedic
• Decision Date: Jun 21, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

tezo™ is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and with autograft to facilitate fusion.

Device Story

The tezo™ Titanium Cage Family consists of interbody fusion cages (tezo-P, tezo-T, tezo-A) designed for lumbar spinal fusion. Implants feature a hollow center to contain autograft to facilitate bone fusion. Available in various heights, lengths, widths, and angulations to match patient anatomy. Used by surgeons in clinical settings during spinal fusion procedures. The device provides structural support to the intervertebral space while fusion occurs. It is used in conjunction with supplemental fixation systems. Benefits include stabilization of the spinal segment and promotion of fusion in patients with degenerative disc disease.

Clinical Evidence

No clinical data. Bench testing only. Mechanical testing included static and dynamic compression per ASTM F2077 and subsidence testing per ASTM F2267 to demonstrate substantial equivalence.

Technological Characteristics

Intervertebral body fusion device manufactured from Ti-6Al-4V titanium alloy (ASTM F136). Features hollow center for autograft. Available in rectangular (tezo-P, tezo-T) and kidney (tezo-A) shapes with various dimensions and angulations. Non-active, mechanical implant.

Indications for Use

Indicated for intervertebral body fusion of lumbar spine (L2-S1) in skeletally mature patients with degenerative disc disease (DDD) and up to Grade I spondylolisthesis or retrolisthesis, following 6 months of failed non-operative treatment. Requires supplemental fixation and autograft.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• pezo™ PEEK Cage Family (K103814)
• Fuse Cage (K100945)
• Fuse Cage (K121288)

Submission Summary (Full Text)

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510(k) Summary

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Image /page/0/Picture/2 description: The image shows the logo for Ulrich medical USA. The word "Ulrich" is in a bold, sans-serif font, with the "U" extending into a black square on the left. Below "Ulrich" is the text "medical USA" in a smaller, sans-serif font.

# JUN 2 1 2012

| Date: | 21 September 2012<br>JUN 21 2013 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | ulrich GmbH & Co. KG<br>Buchbrunnenweg 12<br>89081 Ulm<br>Germany<br>Phone: [phone]<br>Fax: [phone] |
| Contact Person: | Hans Stover<br>ulrich medical USA, Inc.<br>612 Trade Center Blvd.<br>Chesterfield, MO 63005<br>[phone] Office<br>[phone] Fax |
| Proposed Trade Name: | tezo™ Titanium Cage Family |
| Device Classification | Class II |
| Classification Name: | Intervertebral body fusion device |
| Regulation: | 888.3080 |
| Device Product Code: | MAX |
| Device Description: | The tezo™ Titanium Cage Family is comprised of three principal<br>interbody fusion cages. The tezo-P and tezo-T devices have a basic<br>rectangular shape while the tezo-A device has a basic kidney shape.<br>All implants have a hollow center for placement of autograft. The<br>tezo implants are available in an assortment of height, length, width<br>and anteroposterior angulation combinations to accommodate a<br>variety of anatomic requirements |
| Intended Use: | tezo™ is indicated for intervertebral body fusion of the lumbar spine,<br>from L2 to S1, in skeletally mature patients who have had six months<br>of non-operative treatment. The device is intended for use at either<br>one level or two contiguous levels for the treatment of degenerative<br>disc disease (DDD) with up to Grade I spondylolisthesis or<br>retrolisthesis. DDD is defined as back pain of discogenic origin with<br>degeneration of the disc confirmed by history and radiographic<br>studies. The device is intended for use with supplemental fixation<br>and with autograft to facilitate fusion. |
| Materials: | tezo™ devices are manufactured from Ti-6Al-4V titanium alloy which<br>conforms to ASTM F136. |

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Predicate Devices:

### pezo™ PEEK Cage Family - K103814 Fuse Cage - K100945 and K121288

Technological Characteristics: tezo™ possesses the same technological characteristics as one or more of the predicate devices. These include:

- intended use (as described above) .
- . basic design (hollow structure for the containment of autograft),
- . material (titanium),
- manufacturing (additive) .
- sizes (dimensions are comparable to those offered by the ● predicate systems) and

The fundamental scientific technology of tezo™ is the same as previously cleared devices.

#### Performance Data:

Mechanical testing of the worst case tezo™ device included static and dynamic compression according to ASTM F2077 and subsidence according to ASTM F2267.

The mechanical test results demonstrate that tezo™ is substantially equivalent to the predicate devices and therefore that tezo™ is as safe and as effective as the predicate devices.

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Public Health Service

June 21, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WOliti-Cloup Silver Spring, MD 20993-002

ulrich GmbH & Co. KG % ulrich medical USA. Incorporated Mr. Hans Stover President and CEO 612 Trade Center Boulevard Chesterfield. Missouri 63005

Re: K122957

Trade/Device Name: tezo TM Titanium Cage Family Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 11, 2013 Received: June 12. 2013

Dear Mr. Stover:

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 10 devices that have been reclassified in accordance with the provisions of the Federal Food, Drug. and Cosmetic Act (Act) that do not require annroval 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 vou; 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 mav 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

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Page 2 - Mr. Hans Stover

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/CentersOfTices/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.lda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRF'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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

# Anton E. Dmitriev

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

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## Indications for Use Statement

510(k) Number:___K122957 Device Name: tezo™ Titanium Cage Family

Indications for Use:

tezo™ is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and with autograft to facilitate fusion.

Prescription Use _ X

AND/OR

Over-the-Counter Use_ ________________________________________________________________________________________________________________________________________________________

(21 CFR 801 Subpart D)

(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)

> Anton E. Dmitriev, PhD Division of Orthopedic Devices

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