Tryptik Ti

K230583 · Spineart SA · ODP · Mar 22, 2023 · Orthopedic

Device Facts

• Record ID: K230583
• Device Name: Tryptik Ti
• Applicant: Spineart SA
• Product Code: ODP · Orthopedic
• Decision Date: Mar 22, 2023
• Decision: SESE
• Submission Type: Special
• 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 are 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 are 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 are intervertebral body spacers; implanted via anterior cervical approach; facilitate spinal fusion; used with bone graft and supplemental fixation. Manufactured from medical-grade titanium alloy via additive manufacturing (SLM); machined and polished. Intended for use by surgeons in clinical settings. Device extension of previously cleared range; maintains same design, material, and manufacturing technology. Benefits include stabilization of cervical spine segments in patients with DDD.

Clinical Evidence

No clinical data. Bench testing only (referenced from predicate).

Technological Characteristics

Material: Medical grade titanium alloy (ASTM F136). Manufacturing: Additive manufacturing (SLM) per ASTM F3001, followed by machining and polishing. Form factor: Intervertebral body spacers of various shapes/designs. Sterilization: Gamma radiation. Connectivity: None.

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 6 weeks of failed non-operative treatment; used with autogenous/allogeneic bone graft and supplemental cervical 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

• Tryptik® Ti (K200312)
• Tyber Medical PT Interbody Spacer (K182284)

Submission Summary (Full Text)

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March 22, 2023

Spineart SA Franck Pennesi Chief Technical Officer 3 Chemin du Pré -Fleuri Plan-les-Ouates, Geneve 1228 Switzerland

Re: K230583

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 27, 2023 Received: March 2, 2023

Dear Franck 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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 -S

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

Enclosure

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### Indications for Use

510(k) Number (if known) K230583

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 are 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 are 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) | |
|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| <span style="white-space: nowrap;"><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="white-space: nowrap;"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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## Special 510k Tryptik® Ti

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## 510(k) SUMMARY

| 510k | SPECIAL |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Basis for submission | Extension of the range of Tryptik® Ti devices |
| Submitted by | SPINEART<br>3 Chemin du Pré-Fleuri<br>1228 PLAN LES OUATES<br>GENEVA SWITZERLAND |
| Contacts | Franck PENNESI Chief Technical Officer<br>Phone : [phone] Fax : [phone]<br>Mail : [e-mail]<br>Regulatory contact : Estelle LEFEUVRE [e-mail] |
| Date Prepared | February 21st, 2023 |
| Common Name | Intervertebral body fusion device |
| Trade Name | Tryptik® Ti |
| Classification Name | Intervertebral Fusion Device With Bone Graft, Cervical |
| Class | II |
| Product Code | ODP |
| CFR section | 888.3080 |
| Device panel | ORTHOPEDIC |
| Legally marketed predicate devices | Primary predicate: Tryptik® Ti (K200312) manufactured by Spineart<br>Additional predicates: Tyber Medical PT Interbody Spacer (K182284) manufactured by Tyber Medical LLC |
| Indications for use | TRYPTIK®Ti cages are indicated for use in skeletally mature patients<br>with degenerative disc disease (DDD) of the cervical spine with<br>accompanying radicular symptoms at one level or two contiguous disc<br>levels from C2 to T1 disc. DDD is defined as discogenic pain with<br>degeneration of the disc confirmed by patient history and radiographic<br>studies. TRYPTIK®Ti cages are used to facilitate intervertebral body<br>fusion in the cervical spine using autogenous and/or allogeneic bone<br>graft comprised of cancellous and/or corticocancellous bone graft.<br>TRYPTIK®Ti cages are to be used with supplemental fixation that has<br>been cleared for use in the cervical spine. Patients should have at least<br>six (6) weeks of non-operative treatment prior to treatment with an<br>intervertebral cage. |

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| Description of the device | Spineart Tryptik® Ti spinal implants consist in a range of intervertebral<br>body spacers with various shapes and designs so as to be implanted via<br>an anterior cervical approach and to adapt different patient's conditions.<br>The Tryptik® Ti spacers are all made from medical grade titanium alloy<br>conforming to ASTM F136 standard and are produced by additive<br>manufacturing (SLM) according to ASTM F3001. Subsequently the<br>spacer is machined (thread tapping) and polished.<br>The subject implants Tryptik® Ti will extend the previously cleared<br>Tryptik® Ti range of implants (K200312) which presents similar design<br>features and the same manufacturing technology, i.e. additive<br>manufacturing (SLM), and join the previously cleared Tryptik® Ti range<br>of implants (K200312) which addresses the same indications and utilize<br>the same instrumentation designed purposely.<br>The Tryptik® Ti spinal implants are delivered sterile (gamma sterilization)<br>and supplied with dedicated surgical instruments (reusable – provided<br>non-sterile). |
|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>characteristics<br>compared to the<br>predicate devices | The Tryptik® Ti spinal implants are manufactured using the same<br>manufacturing technology, i.e. additive manufacturing (SLM) as<br>predicate device Tryptik® Ti. The characterization of the chemical,<br>physical and mechanical properties of the material was performed in<br>accordance with ASTM F3001 and ASTM E8/E8M.<br>The Tryptik® Ti spinal implants present a similar design feature and<br>range of devices as the previously cleared Tryptik® Ti spinal implants.<br>Both Tryptik® Ti and Tryptik® Ti extension line are designed for an<br>anterior approach.<br>The following non-clinical tests were conducted on predicate devices:<br>Static axial compression, Static shear compression, Static torsion<br>according to ASTM F2077 and subsidence testing according to ASTM<br>F2267. A engineering rationale has been provided to support substantial<br>equivalence. |
| Discussion of Testing | No additional testing has been performed for the Spineart Tryptik® Ti line<br>extension spinal implants. |
| Conclusion | Based on the design features, technological characteristics, feature<br>comparisons, and indications for use, Tryptik® Ti line extension has<br>demonstrated substantial equivalence to the identified predicate devices. |