ZUMA-C

K092521 · Seaspine, Inc. · OVE · Apr 13, 2010 · Orthopedic

Device Facts

• Record ID: K092521
• Device Name: ZUMA-C
• Applicant: Seaspine, Inc.
• Product Code: OVE · Orthopedic
• Decision Date: Apr 13, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Zuma-C is a stand-alone anterior cervical interbody fusion device intended for use as an adjunct to fusion at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Zuma-C is to be packed with autogenous bone graft and implanted via an open, anterior approach. Zuma-C is intended to be used with the bone screw fixation provided and requires no additional fixation.

Device Story

Zuma-C is a stand-alone anterior cervical interbody fusion device; composed of PEEK, titanium alloy, and radiopaque markers; includes titanium screws and locking cover. Device features open central area for autogenous bone graft; implanted via open anterior approach; screws inserted into adjacent vertebral bodies; locking cover secures screws. Used by surgeons in clinical settings to facilitate spinal fusion; provides internal fixation without additional hardware. Benefits patients by stabilizing vertebral segments and promoting fusion in degenerative disc disease cases.

Clinical Evidence

Bench testing only. Conducted per ASTM standards: static/dynamic axial compression, compression shear, and torsion (ASTM F2077); subsidence (ASTM F2267); wear testing (ASTM F2077); and wear debris characterization (ASTM F1714, ASTM F1877). Results demonstrate substantial equivalence to legally marketed devices.

Technological Characteristics

Materials: PEEK, titanium alloy, radiopaque markers. Design: Stand-alone interbody fusion device with integrated screw fixation and locking cover. Testing standards: ASTM F2077 (mechanical/wear), ASTM F2267 (subsidence), ASTM F1714/F1877 (wear debris).

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (discogenic neck pain with confirmed disc degeneration) requiring fusion at one level (C3-C7). Requires prior 6-week non-operative treatment. Contraindications: skeletal immaturity.

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

• Cambria™ (K082309)
• Zuma™ (K082926)
• Zero-P™ (K072981)

Submission Summary (Full Text)

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K092521 Page 1 of 2

## 510(k) Summary

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| Company Name: | SeaSpine, Inc.<br>2302 La Mirada Drive<br>Vista, CA 92081 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| APR 1 3 2010 | |
| Contact Person: | Ethel Bernal<br>Regulatory Affairs Manager<br>E-mail: [e-mail]<br>Phone: [phone], Fax: [phone] |
| Date Prepared: | August 14, 2009 |
| Trade Name: | Zuma-C™ |
| Common Name: | Interbody Fusion Device |
| Classification Name: | Intervertebral Body Fusion Device<br>21 CFR 888.3080, Product Code ODP, Class II<br>Orthopedic Review Committee |
| Device Description: | Zuma-C is a stand-alone interbody fusion device composed of PEEK and<br>titanium alloy with radiopaque markers, titanium screws and a locking<br>cover. The screws are inserted through the device into adjacent<br>vertebral bodies and the locking cover mates with the device, covering<br>the screws. The device has an open central area for receiving bone graft<br>material and is offered pre-assembled in a variety of heights and<br>geometries to accommodate variations patient anatomy. |
| Intended Use: | Zuma-C is a stand-alone anterior cervical interbody fusion device<br>intended for use as an adjunct to fusion at one level (C3-C7) in skeletally<br>mature patients with degenerative disc disease (defined as discogenic<br>neck pain with degeneration of the disc confirmed by history and<br>radiographic studies). Patients should have received at least six weeks<br>of non-operative treatment prior to treatment with the device. Zuma-C<br>is to be packed with autogenous bone graft and implanted via an open,<br>anterior approach. Zuma-C is intended to be used with the bone screw<br>fixation provided and requires no additional fixation. |
| Predicate Devices: | K082309 Cambria™ (SeaSpine, Inc.)<br>K082926 Zuma™ (SeaSpine, Inc.)<br>K072981 Zero-P™ (Synthes Spine) |
| Technological<br>Characteristics: | Zuma-C was shown to be substantially equivalent to predicate<br>devices through comparison in areas including intended use, design,<br>materials, function and ranges of sizes. |

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The following pre-clinical studies were conducted using worst case Performance Data: Zuma-C constructs: 1) static and dynamic axial compression, static and dynamic compression shear, and static and dynamic torsion per ASTM F2077; 2) subsidence per ASTM F2267; 3) wear testing per ASTM F2077; and 4) wear debris characterization per ASTM F1714 and ASTM F1877. The results of these studies were found to be substantially equivalent to legally marketed devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, which is a traditional symbol of medicine and healthcare.

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

SeaSpine, Inc. % Ms. Ethel Bernal Regulatory Affairs Manager 2302 La Mirada Drive Vista, California 92081

Re: K092521

Trade/Device Name: Zuma-C™ Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: February 07, 2010 Received: February 12, 2010

Dear Ms. Bernal:

This letter corrects our substantially equivalent letter of April 13, 2010.

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

SEP 12 2011

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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/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 vours.

Mark A. Millkern

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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Zuma-C™

Indications for Use

510(k) Number (if known): _ KO 92.621

Device Name: Zuma-C™

Indications for Use:

Zuma-C™ is a stand-alone anterior cervical interbody fusion device intended for use as an adjunct to fusion at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and Patients should have received at least six weeks of non-operative radiographic studies). treatment prior to treatment with the device. Zuma-C™ is to be packed with autogenous bone graft and implanted via an open, anterior approach. Zuma-C™ is intended to be used with the bone screw fixation provided and requires no additional fixation.

Prescription Use × (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)

Division Sign-Off

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

KO92521 510(k) Number_

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