Tryptik Ti

K200312 · Spineart · ODP · Apr 6, 2020 · Orthopedic

Device Facts

• Record ID: K200312
• Device Name: Tryptik Ti
• Applicant: Spineart
• Product Code: ODP · Orthopedic
• Decision Date: Apr 6, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TRYPTIK®Ti cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous disc levels from C2 to T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radios. TRYPTIK®Ti cages is used to facilitate intervertebral body fusion in the cervical spine using autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. TRYPTIK®Ti cages is to be used with supplemental fixation that has been cleared for use in the cervical spine. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Device Story

Tryptik® Ti is an anterior cervical interbody fusion device; provides mechanical support to cervical spine; maintains disc space during fusion. Device is a box-shaped spacer with central cavity for bone graft; monolithic design with solid and porous structures; superior/inferior rough surfaces for stability and bony integration. Implanted via anterior approach by surgeons in clinical settings. Device supports fusion using autogenous/allogeneic bone graft; requires supplemental fixation. Benefits patient by stabilizing intervertebral space and promoting fusion in DDD cases.

Clinical Evidence

Bench testing only. Mechanical performance evaluated via static and dynamic axial compression, shear-compression, and torsion (ASTM F2077-18) and subsidence testing (ASTM F2267-04). Mass loss measured on worst-case specimens. Cadaver lab implantation trials conducted.

Technological Characteristics

Medical grade titanium alloy; additive manufacturing (SLM) per ASTM F3001; monolithic design with solid and porous structures; rough surfaces; gamma sterilized; supplied with reusable surgical instruments; pyrogenicity testing per USP standard (limit 20 EU/device).

Indications for Use

Indicated for skeletally mature patients with cervical degenerative disc disease (DDD) at one or two contiguous levels (C2-T1) with radicular symptoms. Requires failure of at least 6 weeks of non-operative treatment. Used with autogenous/allogeneic bone graft 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

• Tritanium C Anterior Cervical Cage (K171496)
• Tryptik® CA/CC (K091873 / K122366)
• EIT Cellular Titanium Cervical Cage (K170503 / K172888)
• EIT Cellular Titanium PLIF Cages (K170503 / K172888)
• EIT Cellular Titanium TLIF Cages (K170503 / K172888)
• EIT Cellular Titanium ALIF Cage (K170503 / K172888)
• Juliet® Ti (K153621)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

April 6, 2020

Spineart Mr. Frank Pennesi Chief Technical Officer 3 Chemin du Pré Fleuri 1228 Plan les Quates Switzerland

Re: K200312

Trade/Device Name: Tryptik® Ti Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: February 3, 2020 Received: February 6, 2020

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Brent Showalter, Ph.D. Acting Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K200312 Device Name TRYPTIK®Ti

## Indications for Use (Describe)

TRYPTIK®Ti cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous disc levels from C2 to T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radios. TRYPTIK®Ti cages is used to facilitate intervertebral body fusion in the cervical spine using autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. TRYPTIK®Ti cages is to be used with supplemental fixation that has been cleared for use in the cervical spine. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

PSC Publishing Services [phone]

{3}------------------------------------------------

Image /page/3/Picture/2 description: The image shows the logo for Spineart. The logo consists of the word "spineart" in a stylized font, with the "art" portion in a lighter color. Above and to the right of the word is a purple butterfly.

## 510(k) SUMMARY

| 510k | TRADITIONAL |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Basis for submission | New devices |
| Submitted by | SPINEART |
| | 3 Chemin du Pré Fleuri |
| | 1228 PLAN LES OUATES |
| | GENEVA SWITZERLAND |
| Contacts | Franck PENNESI Chief Technical Officer |
| | Phone: [phone] Fax: [phone] |
| | Mail: [e-mail] |
| | Regulatory contact: Dr Isabelle DRUBAIX (Idée Consulting) [e-mail] |
| Date Prepared | January 28, 2020 |
| Common Name | Intervertebral body fusion device |
| Trade Name | TRYPTIK®Ti Anterior Cervical Intervertebral Fusion Devices |
| Classification Name | Intervertebral Fusion Device with Bone Graft, Cervical |
| Class | II |
| Product Code | ODP |
| CFR section | 888.3080 |
| Device panel | ORTHOPEDIC |
| Legally marketed<br>predicate devices | Primary predicate: Tritanium C Anterior Cervical Cage (K171496) manufactured by |
| | STRYKER SPINE |
| | Additional predicates: Tryptik® CA/CC (K091873 / K122366) manufactured by |
| | SPINEART; EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT |
| | Cellular Titanium TLIF Cages, And EIT Cellular Titanium ALIF Cage (K170503 / K172888) |
| | manufactured by EIT Emerging Implant Technologies GmbH and Juliet® Ti (K153621) manufactured by Spineart. |
| Indications for use | TRYPTIK®Ti cages are indicated for use in skeletally mature patients with degenerative |
| | disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one |
| | level or two contiguous disc levels from C2 to T1 disc. DDD is defined as discogenic |
| | pain with degeneration of the disc confirmed by patient history and radiographic |
| | studies. TRYPTIK®Ti cages is used to facilitate intervertebral body fusion in the cervical |
| | spine using autogenous and/or allogeneic bone graft comprised of cancellous and/or |
| | corticocancellous bone graft. TRYPTIK®Ti cages is to be used with supplemental |
| | fixation that has been cleared for use in the cervical spine. Patients should have at |
| | least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. |
| Description of the device | The Tryptik® Ti is an anterior cervical interbody fusion device intended to provide<br>mechanical support to the cervical spine and maintain adequate disc space until fusion<br>occurs. The interbody device is a box-shaped spacer with a large central cavity that<br>can receive bone graft intended to promote intervertebral fusion. The Tryptik®<br>Ti spacers are all made from medical grade titanium alloy and are produced by<br>additive manufacturing (SLM) according to ASTM F3001. Subsequently the<br>spacer is machined (thread tapping) and polished. The Tryptik® Ti interbody<br>spacer has a monolithic design that incorporates solid and porous structures<br>along with superior and inferior rough surfaces intended to increase implant stability<br>into the intervertebral space and bony integration throughout the implant.<br>The Tryptik® Ti spacers are delivered sterile (gamma sterilization) and supplied<br>with dedicated surgical instruments (reusable – provided non-sterile). Bacterial<br>endotoxin testing on final, finished devices as specified in USP standard is used for<br>pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device. |
| Technological<br>characteristics compared<br>to the predicate devices | The Tryptik® Ti spacers are available in various sizes, heights, footprints and lordosis<br>so as to adapt individual pathology and different patient's anatomical conditions. The<br>Tryptik® Ti spacers are implanted via an anterior approach. These features are similar<br>to those of the predicate devices (K171496, K091873 / K122366 and K170503 /<br>K172888).<br>The Tryptik® Ti spacers present the same monolithic design that incorporates solid<br>and porous structures and are manufactured using the same manufacturing<br>technology, i.e. additive manufacturing (SLM) as other cleared devices from Spineart. |
| Discussion of Testing | The following non-clinical tests were conducted on the Tryptik® Ti spacers Static<br>and Dynamic Axial Compression, Static and Dynamic Shear-compression and<br>Static and Dynamic Torsion according to ASTM F2077-18 and Subsidence<br>according to ASTM F2267-04. Results demonstrate comparable mechanical<br>properties to the identified predicate devices. Mass loss was measured on post-test<br>run out Tryptik® Ti worst-case specimens dynamically tested.<br>Additionally, cadaver lab implantation trials were conducted. |
| Conclusion | Based on the design features, technological characteristics, feature comparisons,<br>indications for use, and non-clinical performance testing, the Tryptik® Ti spacers have<br>demonstrated substantial equivalence to the identified predicate devices. |

{4}------------------------------------------------