TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGE

K122366 · Spineart · ODP · Oct 4, 2012 · Orthopedic

Device Facts

• Record ID: K122366
• Device Name: TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGE
• Applicant: Spineart
• Product Code: ODP · Orthopedic
• Decision Date: Oct 4, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TRYPTIK® 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® cages are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. TRYPTIK® cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment.

Device Story

TRYPTIK® Anterior Intersomatic Cervical Cage is an intervertebral body fusion device designed for anterior cervical spine surgery. The device is implanted by a surgeon to facilitate fusion at one disc level (C3-C7) in patients with degenerative disc disease. It acts as a structural spacer to maintain disc space height while bone healing occurs. The cage is packed with autograft bone and used in conjunction with supplemental fixation hardware. The device features titanium markers to assist the surgeon in verifying implant positioning via radiographic imaging post-operatively. The primary benefit is the stabilization of the spinal segment to alleviate radicular symptoms associated with disc degeneration.

Clinical Evidence

No clinical data presented. Performance is supported by bench testing, including static and dynamic compression, shear, and torsion tests per ASTM F2077, and subsidence testing per ASTM F2267.

Technological Characteristics

Materials: PEEK OPTIMA LT1 (ASTM F2026) with titanium markers (ASTM F136). Design: Lordotic and convex intersomatic cage for anterior cervical approach. Energy source: None (mechanical implant). Sterilization: Not specified. 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 autograft bone and supplemental fixation. Patients must have failed at least 6 weeks of 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

• TRYPTIK® Anterior Intersomatic Cervical Cage (K091873)
• CRYSTAL (K073351)
• ALEUTIAN (K101302)

Submission Summary (Full Text)

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K122366
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## 510(k) SUMMARY

As required by section 807.92

ост 4 2012

| Submitter | SPINEART<br>International Center Cointrin 20 route de pré-bois CP1813<br>1215 GENEVA 15<br>SWITZERLAND |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contacts | Franck PENNESI Director of Industry & Quality<br>Phone : [phone] Fax : [phone]<br>Mail : [e-mail]<br>Regulatory contact : Dr Isabelle DRUBAIX (Idée Consulting)<br>[e-mail] |
| Type of 510k | SPECIAL |
| Preparation date | Revised September 9th 2012 |
| Trade Name | TRYPTIK® Anterior Intersomatic Cervical Cage |
| Classification Name | Intervertebral body fusion device- Cervical |
| Class | II |
| Product Code | ODP |
| CFR section | 888.3080 |
| Device panel | Orthopedic |
| Legally marketed<br>predicate devices | TRYPTIK® Anterior Intersomatic Cervical Cage manufactured by<br>SPINEART (K091873); CRYSTAL manufactured by SPINAL ELEMENTS,<br>INC (K073351); ALEUTIAN manufactured by K2M (K101302) |
| Description | The components added within this submission include lordotic and<br>convex TRYPTIK® cc anterior intersomatic cervical cages. TRYPTIK®<br>devices are made of PEEK OPTIMA LT1 conforming ASTM F2026.<br>Markers made of titanium conforming ASTM F136 are used to visualize<br>the position of the implant in the disc space. TRYPTIK® devices are<br>designed for an anterior approach. |
| Intended Use | TRYPTIK® cages are indicated for use in skeletally mature patients with<br>degenerative disc disease (DDD) of the cervical spine with<br>accompanying radicular symptoms at one disc level. DDD is defined as<br>discogenic pain with degeneration of the disc confirmed by patient<br>history and radiographic studies. TRYPTIK® cages are used to facilitate<br>intervertebral body fusion in the cervical spine at the C3 to C7 disc<br>levels using autograft bone. TRYPTIK® cages are to be used with<br>supplemental fixation. Patients should have at least six (6) weeks of<br>non-operative treatment. |
| Performance data | TRYPTIK® cervical interbody fusion devices conform to Class II Special<br>Controls Guidance Document: Intervertebral Body Fusion Device-<br>Document issued on: June 12, 2007.<br>Mechanical testing including Static and dynamic compression, static<br>and dynamic shear, static and dynamic torsion tests have been<br>performed according to ASTM F2077 and subsidence testing has been<br>performed according to ASTM F2267. Results demonstrate that<br>additional components perform as safely and effectively as their<br>predicate devices. No clinical data has been presented. |
| Substantial equivalence | TRYPTIK® cervical interbody fusion devices are substantially equivalent<br>to their predicate devices in terms of intended use, material, design,<br>mechanical properties and function. Non clinical performance testing<br>according to special control demonstrate that additional components<br>are as safe, as effective, and performs as safely and effectively as their<br>predicate devices. |

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

SPINEART % Mr. Frank Pennesi Director of Industry and Quality International Center Cointrin, 20 route de-Pré-bois CP1813 1215 Geneva, Switzerland

OCT
4 2012

Re: K122366 Trade/Device Name: TRYPTIK® Anterior Intersomatic Cervical Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: September 10, 2012 Received: September 11, 2012

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. 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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## Page 2 - Mr. Frank Pennesi

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

Sincerely yours,

Mark N. Melkerson

Mark N. Me 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): K122366

Device Name: TRYPTIK® Anterior Intersomatic Cervical Cage Indications for Use:

TRYPTIK® 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® cages are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. TRYPTIK® cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment

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)

Cal. Pf.

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

510(k) Number k122366