PEZO INTERBODY CAGES SYSTEM

K103814 · Ulrich GmbH & Co. KG · MAX · Mar 17, 2011 · Orthopedic

Device Facts

• Record ID: K103814
• Device Name: PEZO INTERBODY CAGES SYSTEM
• Applicant: Ulrich GmbH & Co. KG
• Product Code: MAX · Orthopedic
• Decision Date: Mar 17, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

pezo™ 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 pezo™ PEEK Cage Family consists of interbody fusion cages (rectangular or kidney-shaped) designed for lumbar spine fusion. Implants feature a hollow center to contain autograft. Available in various heights, lengths, widths, and angulations to match patient anatomy. Used by surgeons in clinical settings to treat degenerative disc disease. The device is implanted during surgery to provide structural support and facilitate fusion, requiring supplemental fixation. Tantalum markers are included for radiographic visualization. The device functions as a mechanical spacer to maintain disc space height while bone fusion occurs.

Clinical Evidence

Bench testing only. Mechanical testing of the worst-case device included static and dynamic compression testing per ASTM F2077 and subsidence testing per ASTM F2267. No clinical data was provided.

Technological Characteristics

Manufactured from polyetheretherketone (PEEK Optima LT1) per ASTM F2026. Includes integral tantalum markers per ASTM F560. Hollow design for autograft. Dimensions vary by anatomic requirement. Non-active, mechanical implant.

Indications for Use

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

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

• Lumbar I/F Cage® (P960025)
• Ray TFC™ Device (P950019)
• AVS PEEK Spacers (K073470, K082014, K083661 and K090166)

Submission Summary (Full Text)

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KIO3814

MAR 1 7 2011

Image /page/0/Picture/2 description: The image shows the logo for Ulrich medical USA. The logo consists of the word "Ulrich" in a bold, sans-serif font, with the "U" stylized to appear as if it is emerging from a black square. Below the word "Ulrich" is the phrase "medical USA" in a smaller, sans-serif font.

# 510(k) Summary

| Date: | 22 December 2010 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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<br>Name: | pezo™ PEEK Cage Family |
| Device Classification | Class II |
| Classification Name: | Intervertebral body fusion device |
| Regulation: | 888.3080 |
| Device Product<br>Code: | MAX |
| Device Description: | The pezo™ PEEK Cage Family is comprised of three principal<br>interbody fusion cages. The pezo-P and pezo-T devices have a<br>basic rectangular shape while the pezo-A devices have a basic<br>kidney shape. All implants have a hollow center for placement of<br>autograft. The pezo implants are available in an assortment of<br>height, length, width and anteroposterior angulation combinations to<br>accommodate a variety of anatomic requirements. |
| Intended Use: | pezo™ 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: | pezo™ components are manufactured from polyetheretherketone<br>(PEEK Optima LT1) as described by ASTM F2026. Integral markers<br>are manufactured from tantalum according to ASTM F560. |

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K103814

## Predicate Devices:

### Technological Characteristics:

Lumbar I/F Cage® (P960025)

Ray TFC™ Device (P950019)

AVS PEEK Spacers (K073470, K082014, K083661 and K090166)

pezo™ 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 (polymer),
- sizes (dimensions are comparable to those offered by the . predicate systems) and

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

#### Performance Data:

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

The mechanical test results demonstrate that pezo™ performs as well as or better than the predicate devices and therefore that the device is as safe and as effective as the predicates.

Confidential: pezo
TM Family

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract image of an eagle.

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

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

MAR 1 7 2011

Re: K103814

Trade/Device Name: pezo™ PEEK Cage Family Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: December 22, 2010 Received: December 29, 2010

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 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. Hans Stover

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/ReportalProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

A
for
B.R h

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 Statement

510(k) Number:_K103814

Device Name: pezo™ PEEK Cage Family

Indications for Use:

pezo™ 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 (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

KI03814 510(k) Number.