NUBIC AND RABEA DEVICES

K082848 · Signus Medizintechnik GmbH · ODP · Jul 24, 2009 · Orthopedic

Device Facts

• Record ID: K082848
• Device Name: NUBIC AND RABEA DEVICES
• Applicant: Signus Medizintechnik GmbH
• Product Code: ODP · Orthopedic
• Decision Date: Jul 24, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

When used as a vertebral body replacement, the NUBIC devices are indicated for use in skeletally mature patients to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. The NUBIC device may be implanted singularly or in pairs and may be used with allograft or autograft. When used as an intervertebral fusion device, the NUBIC devices are intended for use in skeletally mature patients at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. The devices are designed for use with autograft to facilitate fusion and intended for use with supplemental internal fixation. One NUBIC device is used per intervertebral space. A connecting screw is available which allows the NUBIC device (without strut) to be physically attached to the SIGNUS TOSCA or TOSCA II anterior cervical plate systems if desired.

Device Story

NUBIC and RABEA are rectangular frame implants for spinal stabilization; used as vertebral body replacements (thoracolumbar) or intervertebral fusion devices (cervical). Implants feature surface spikes for anchorage; available in various sizes. NUBIC includes optional connecting screw for attachment to SIGNUS TOSCA II anterior cervical plate. Implants are placed by surgeons during spinal procedures to restore height or facilitate fusion. Benefit: structural support and stabilization of the spine in patients with degenerative disease, tumor, or trauma.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and performance characteristics.

Technological Characteristics

Materials: PEEK-OPTIMA LT1 (ASTM F2026) and titanium alloy Ti-6Al-4V (ASTM F136). Form factor: Rectangular frame with surface spikes. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients requiring vertebral body replacement (thoracolumbar T1-L5) due to tumor or trauma/fracture, or intervertebral fusion (cervical C3-T1) for discogenic neck pain with degeneration after 6 weeks of failed non-operative treatment. Requires supplemental internal fixation and bone graft (autograft/allograft).

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.

Reference Devices

• SIGNUS TOSCA anterior cervical plate
• SIGNUS TOSCA II anterior cervical plate

Submission Summary (Full Text)

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# K0 82848 page 1 of Z

| 510(k) Summary | |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | JUL 2 4 2009<br>SIGNUS Medizintechnik GmbH<br>Carl-Zeiss-Strasse 2<br>D-63755 Alzenau, GERMANY |
| | Tel + 49 (0) 6023 9166-136<br>Fax + 49 (0) 6023 9166-161<br>Url: http://www.signus-med.de |
| Contact Person: | Jörg Degen, Regulatory Affairs, QM |
| Proposed Trade Name: | NUBIC™ device |
| Device Classification | Class II |
| Classification Name: | Spinal vertebral body replacement device; Intervertebral fusion device with<br>bone graft, cervical |
| Regulation: | 888.3060; 888.3080 |
| Device Product Code: | MQP; ODP |
| Device Description: | The basic shape of the NUBIC device is a rectangular frame. The upper and<br>lower aspects of the implant are open with surface spikes which assist in the<br>positive anchorage and seating of the implant between the superior and<br>inferior vertebral bodies. The device is available in a variety of sizes<br>enabling the surgeon to choose the size best suited to the individual<br>pathology and anatomical condition. A connecting screw is available which<br>permits attachment of the NUBIC (without strut) to the Signus TOSCA II<br>anterior cervical plate if the surgeon so chooses. |
| Intended Use: | When used as a vertebral body replacement, the NUBIC devices are<br>indicated for use in skeletally mature patients to replace a vertebral body<br>that has been resected or excised due to tumor or trauma/fracture. The<br>device is intended for use in the thoracolumbar spine (from T1 to L5) and is<br>intended for use with supplemental internal fixation. The NUBIC device<br>may be implanted singularly or in pairs and may be used with allograft or<br>autograft. |
| | When used as an intervertebral fusion device, the NUBIC devices are<br>intended for use in skeletally mature patients at one level in the cervical<br>spine, from C3 to T1, for the treatment of cervical disc disease (defined as<br>neck pain of discogenic origin with degeneration of the disc confirmed by<br>history and radiographic studies). The cervical device is to be used in<br>patients who have had six weeks of non-operative treatment. The devices<br>are designed for use with autograft to facilitate fusion and intended for use<br>with supplemental internal fixation. One NUBIC device is used per<br>intervertebral space. A connecting screw is available which allows the<br>NUBIC device (without strut) to be physically attached to the SIGNUS<br>TOSCA or TOSCA II anterior cervical plate systems if desired. |
| Materials: | The NUBIC device is manufactured from polyetheretherketone (PEEK-<br>OPTIMA® LT1, Invibio™) as described by ASTM F2026. Integral marker<br>pins in the implants and the connecting screw are manufactured from<br>titanium alloy (Ti-6Al-4V) as described by ASTM F136. |
| Substantial<br>Equivalence: | Documentation was provided which demonstrated the NUBIC to be<br>substantially equivalent to previously cleared devices. The substantial<br>equivalence is based upon equivalence in basic design, intended use,<br>indications, anatomic sites and performance. |

:

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and the state of the state of the states and

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## K082848 Page 2 of Z

| 510(k) Summary | |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | SIGNUS Medizintechnik GmbH<br>Carl-Zeiss-Strasse 2<br>D-63755 Alzenau, GERMANY<br>Tel. + 49 (0) 6023 9166-136<br>Fax + 49 (0) 6023 9166-161<br>Url: http://www.signus-med.de |
| Contact Person: | Jörg Degen, Regulatory Affairs, QM |
| Proposed Trade Name: | RABEA™ device |
| Device Classification | Class II |
| Classification Name: | Spinal vertebral body replacement device; Intervertebral fusion device with<br>bone graft, cervical |
| Regulation: | 888.3060; 888.3080 |
| Device Product Code: | MQP; ODP |
| Device Description: | The basic shape of the RABEA device is a rectangular frame. The upper<br>and lower aspects of the implant are open with surface spikes which assist<br>in the positive anchorage and seating of the implant between the superior<br>and inferior vertebral bodies. The device is available in a variety of sizes<br>enabling the surgeon to choose the size best suited to the individual<br>pathology and anatomical condition. |
| Intended Use: | When used as a vertebral body replacement, the RABEA devices are<br>indicated for use in skeletally mature patients to replace a vertebral body<br>that has been resected or excised due to tumor or trauma/fracture. The<br>device is intended for use in the thoracolumbar spine (from T1 to L5) and is<br>intended for use with supplemental internal fixation. The RABEA device is<br>intended to be implanted in pairs and may be used with allograft or<br>autograft.<br><br>When used as an intervertebral fusion device, the RABEA devices are<br>intended for use in skeletally mature patients at one level in the cervical<br>spine, from C3 to T1, for the treatment of cervical disc disease (defined as<br>neck pain of discogenic origin with degeneration of the disc confirmed by<br>history and radiographic studies). The cervical device is to be used in<br>patients who have had six weeks of non-operative treatment. The devices<br>are designed for use with autograft to facilitate fusion and intended for use<br>with supplemental internal fixation. One RABEA device is used per<br>intervertebral space. |
| Materials: | The RABEA device is manufactured from either titanium alloy (Ti-6Al-4V)<br>as described by ASTM F136 or polyetheretherketone (PEEK-OPTIMA®<br>LT1, Invibio™) as described by ASTM F2026. Integral marker pins in the<br>PEEK implants are manufactured from titanium alloy (Ti-6Al-4V) as<br>described by ASTM F136. |
| Substantial<br>Equivalence: | Documentation was provided which demonstrated the RABEA to be<br>substantially equivalent to previously cleared devices. The substantial<br>equivalence is based upon equivalence in basic design, intended use,<br>indications, anatomic sites and performance. |

. . . .

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 eagle with three stripes forming its wing and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SIGNUS Medizintechnik GmbH % Dr. Karen E. Warden, Ph.D. Representative/Consultant 8202 Sherman Road Chesterland, OH 44026-2141

Re: K082848

Trade/Device Name: NUBIC™ and RABEA™ Devices Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, MQP Dated: July 22, 2009 Received: July 23, 2009

JUL 2 4 2009

#### Dear Dr. Warden:

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.

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical of it rate of your may (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Dr. Karen E. Warden

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

Sincerely yours,
Harbare frels

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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## K08 2848 Page 1 of 2

#### Indications for Use Statement

510(k) Number:

Device Name: NUBIC device

Indications for Use:

When used as a vertebral body replacement, the NUBIC devices are indicated for use in skeletally mature patients to replace a vertebral body that has been resected or excised due to turnor or trauma/fracture. The device is intended for use in the thoracolumbar spine (from TI to LS) and is intended for use with supplemental internal fixation. The NUBIC device may be implanted singularly or in pairs and may be used with allograft or autograft.

When used as an intervertebral fusion device, the NUBIC devices are intended for use in skeletally mature patients at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. The devices are designed for use with autograft to facilitate fusion and intended for use with supplemental internal fixation. One NUBIC device is used per intervertebral space. A connecting screw is available which allows the NUBIC device (without strut) to be physically attached to the SIGNUS TOSCA II anterior cervical plate systems if desired.

Prescription Use (Per 21 CFR 801.109)

OR

Over-the-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ea
(EXT for MXM

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

510(k) Number K082848

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### K082848 page 2 of

Over-the-Counter Use

#### Indications for Use Statement

510(k) Number:

Device Name: RABEA device

Indications for Use:

When used as a vertebral body replacement, the RABEA devices are indicated for use in skeletally mature patients to replace a vertebral body that has been resected or excised due to turnor or trauma/fracture. The device is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. The RABEA device is intended to be implanted in pairs and may be used with allograft or autograft.

When used as an intervertebral fusion device, the RABEA devices are intended for use in skeletally mature patients at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment. The devices are designed for use with autograft to facilitate fusion and intended for use with supplemental internal fixation. One RABEA device is used per intervertebral space.

Prescription Use X (Per 21 CFR 801.109)

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

En (Ext for Mux)

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

510(k) Number_に08ことよ48