RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM

K111272 · Rhausler, Inc. · OVE · Nov 29, 2011 · Orthopedic

Device Facts

• Record ID: K111272
• Device Name: RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM
• Applicant: Rhausler, Inc.
• Product Code: OVE · Orthopedic
• Decision Date: Nov 29, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. This device is to be used in patients who have had at least 6 weeks of nonoperative treatment.

Device Story

The Rhausler Plage Anterior Cervical Fusion System is an intervertebral body fusion device consisting of a titanium plate-cage combination and titanium locking bone screws. The device is implanted via an open, anterior approach to the cervical spine. The central cage portion is packed with autogenous bone to facilitate fusion. It is intended for use in skeletally mature patients with degenerative disc disease at one level (C3-C7) who have failed at least 6 weeks of nonoperative treatment. The device provides structural support and stabilization during the spinal fusion process.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F2077 (static/dynamic compression and torsion), ASTM F2267 (subsidence), and ASTM F1877 (wear). Results demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Titanium intervertebral body fusion device (plate and cage combination) with titanium locking bone screws. Nonsterile. Mechanical testing per ASTM F2077, ASTM F2267, and ASTM F1877.

Indications for Use

Indicated for spinal fusion at one level (C3-C7) in skeletally mature patients with degenerative disc disease of the cervical spine, following at least 6 weeks of failed nonoperative 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

• Mosaic (K071833)
• Zuma-CTM (K092521)

Submission Summary (Full Text)

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NOV 2 9 2011

## Abbreviated 510(k) Rhausler Plage Anterior Cervical Fusion System

## Section 5: 510(k) Summary

Assigned 510(k) number: K11272 Company: Rhausler Inc. 837 Industrial Road, Unit E San Carlos, CA 94070 USA Phone: [phone] Fax: [phone] Contact: Barbara DeBiase Phone: [phone] Email: [e-mail] November 28, 2011 Date Prepared: Rhausler Plage™ Anterior Cervical Fusion System Proprietary Names: Classification Name: Intervertebral body fusion device 21 CFR 888.3080, Class II, Product Code ODP Classification: K071833 Mosaic™ by Spinal Elements Inc. Predicate Devices: K092521 Zuma-CTM by Seaspine Inc. Device Description: The Rhausler Plage Anterior Cervical Fusion System consists of titanium plage (one piece cervical plate and cage) implants, titanium locking bone screw implants, and instruments. Implants are provided in a variety of dimensions. The Plage is designed with slots for bone screw placement. The Plage center lower cage portion is open to allow the opening to be filled with autogenous bone. The Plage System is provided nonsterile. Intended for spinal fusion procedures at one level (C3-C7) in Intended Use: skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. This device is to be used in patients who have had at least 6 weeks of nonoperative treatment. Technological Comparison to Predicate Device: The Rhausler Plage Anterior Cervical Fusion System is similar to the predicate device. Both are intervertebral body fusion devices

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that attach to the anterior portion of the cervical spine during the development of spinal fusion. Additionally, both use the same fundamental scientific technology, principle of operation, and materials. Performance test results confirm that design differences do not pose new issues of safety or effectiveness.

- Mechanical testing has been performed on the Rhausler Plage Performance Testing: Anterior Cervical Fusion System per ASTM F2077 (static and dynamic compression and torsion). Subsidence testing has been performed per ASTM F2267, and wear testing has been performed per ASTM F1877. Results of performance testing are substantially equivalent to the predicate devices.
- Based upon the design, technology, performance, and intended use, Conclusion: Rhausler Plage Anterior Cervical Fusion System is the substantially equivalent to the predicate device currently marketed under the Food, Drug and Cosmetic Act.

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

NOV 29 2011

Rhausler, Inc. % Ms. Barbara DeBiase 837 Industrial Road, Unit E San Carlos, California 94070

Re: K111272

Trade/Device Name: Rhausler Plage ** Anterior Cervical Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: October 10, 2011 Received: October 11, 2011

Dear Ms. DeBiase:

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

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Page 2 - Ms. Barbara DeBiase

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/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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

ely yours,

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): k111272

Device Name: Rhausler Plage™ Anterior Cervical Fusion System

Indications for Use:

Intended for spinal fusion procedures at one level (C3-C7) in skcletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. This device is to be used in patients who have had at least 6 weeks of nonoperative treatment.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

. . .

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)

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

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