TRYPTIK CA ANTERIOR INTERSOMATIC CERVICAL CAGE, MODELS MOS-CA 12 05-S, MOS-CA 12 O6-S

K091873 · Spineart · ODP · Sep 18, 2009 · Orthopedic

Device Facts

• Record ID: K091873
• Device Name: TRYPTIK CA ANTERIOR INTERSOMATIC CERVICAL CAGE, MODELS MOS-CA 12 05-S, MOS-CA 12 O6-S
• Applicant: Spineart
• Product Code: ODP · Orthopedic
• Decision Date: Sep 18, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TRYPTIK®ca cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. TRYPTIK®ca are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. TRYPTIK®ca are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage

Device Story

TRYPTIK ca is an intervertebral body fusion device designed for anterior cervical approach. Implant consists of PEEK OPTIMA cage with titanium markers for radiographic visualization. Device implanted by surgeons to facilitate fusion at C3-C7 levels in patients with DDD. Requires use of autograft bone and supplemental fixation. Supplied sterile.

Clinical Evidence

No clinical data. Substantial equivalence based on design, material, and mechanical property comparisons to predicate devices.

Technological Characteristics

Materials: PEEK OPTIMA (ASTM F2026) and titanium markers (ASTM F136). Form factor: Cervical interbody fusion cage. Sterilization: Supplied sterile. Connectivity: None.

Indications for Use

Indicated for skeletally mature patients with cervical degenerative disc disease (DDD) and radicular symptoms at one level (C3-C7). Requires at least 6 weeks of prior non-operative treatment. Must be used with autograft bone and supplemental fixation.

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

• AFFINITY ANTERIOR CERVICAL CAGE SYSTEM (P000028)
• CERVICAL INTERBODY FUSION DEVICE (P980048)
• CRYSTAL (K073351)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and EFFECTIVENESS

SEP 1 8 2009

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As required by section 807.92(c)

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| | SPINEART | | |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------|------------------------------------------------------|--|
| Submitter | International Center Cointrin 20 route de pré-bois | | |
| | CP1813 | | |
| | 1215 GENEVA 15 | | |
| | SWITZERLAND | | |
| Contacts | Franck PENNESI Director of Industry & Quality | | |
| | Phone : [phone] | | |
| | Fax : [phone] | | |
| | Mail : [e-mail] | | |
| | Regulatory contact : Dr Isabelle DRUBAIX (Idée | | |
| | Consulting) [e-mail] | | |
| Preparation date | June 9, 2009 | | |
| Trade Name | TRYPTIK ca | | |
| Classification Name | Intervertebral body fusion device- Cervical | | |
| Class | II | | |
| Product Code | ODP | | |
| CFR section | 888.3080 | | |
| Device panel | Orthopedic | | |
| Legally marketed<br>predicate devices | AFFINITY ANTERIOR CERVICAL CAGE SYSTEM<br>(P000028) manufactured by MEDTRONIC, BAK/C | | |
| | CERVICAL INTERBODY FUSION DEVICE (P980048)<br>manufactured by ZIMMER SPINE, CRYSTAL (K073351) | | |
| | manufactured by SPINAL ELEMENTS, INC | | |
| | Description | TRYPTIK ca of cervical interbody fusion devices made | |
| | | of PEEK OPTIMA conforming ASTM F2026. Markers | |
| made of titanium conforming ASTM F136 are used to | | | |
| visualize the position of the implant in the disc space. | | | |
| TRYPTIK ca devices are designed for an anterior | | | |
| approach. All devices are supplied sterile. | | | |

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| | Intended Use | TRYPTIK®ca cages are indicated for use in skeletally<br>mature patients with degenerative disc disease (DDD)<br>of the cervical spine with accompanying radicular<br>symptoms at one disc level. DDD is defined as<br>discogenic pain with degeneration of the disc<br>confirmed by patient history and radiographic studies.<br>TRYPTIK®ca are used to facilitate intervertebral body<br>fusion in the cervical spine at the C3 to C7 disc levels<br>using autograft bone. TRYPTIK®ca are to be used with<br>supplemental fixation. Patients should have at least<br>six (6) weeks of non-operative treatment prior to<br>treatment with an intervertebral cage |
|--|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Performance data | TRYPTIK ca cervical interbody fusion devices conform<br>to Class II Special Controls Guidance Document:<br>Intervertebral Body Fusion Device- Document issued<br>on: June 12, 2007 |
| | Substantial<br>equivalence | TRYPTIK cervical interbody fusion device is<br>substantially equivalent to its predicate devices in<br>terms of intended use, material, design, mechanical<br>properties and function. |

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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 and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is smaller than the caduceus symbol.

SEP 1 8 2009

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

Spineart % Franck Pennesi International Center Cointrin 20 Route de Pre-Bois, CP1813 Geneva Switzerland 1215

### Re: K091873

Trade/Device Name: TRYPTIK CA Anterior Intersomatic Cervical Cage Regulation Number: 21 CFR 888,3080

Regulation Name: Intervertebral Body Fusion Device

Regulatory Class: Class II

Product Code: ODP

Dated: June 22, 2009

Received: June 23, 2009

#### Dear Mr. Pennesi:

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 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.

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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 yours,

Voubeu Muchm

Mark N. Melker 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): Device Name: TRYPTIK ca Indications for Use:

TRYPTIK®ca cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. TRYPTIK®ca are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. TRYPTIK®ca are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage

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

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)

Kareem S. Burney for MxM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091873

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