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 Description

Spineart Tryptik® Ti spinal implants consist in a range of intervertebral body spacers with various shapes and designs so as to be implanted via an anterior cervical approach and to adapt different patient's conditions. The Tryptik® Ti spacers are all made from medical grade titanium alloy conforming to ASTM F136 standard and are produced by additive manufacturing (SLM) according to ASTM F3001. Subsequently the spacer is machined (thread tapping) and polished. The subject implants Tryptik® Ti will extend the previously cleared Tryptik® Ti range of implants (K200312) which presents similar design features and the same manufacturing technology, i.e. additive manufacturing (SLM), and join the previously cleared Tryptik® Ti range of implants (K200312) which addresses the same indications and utilize the same instrumentation designed purposely. The Tryptik® Ti spinal implants are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments (reusable – provided non-sterile).

AI/ML Overview

This is a 510(k) premarket notification for a medical device called Tryptik® Ti, an intervertebral body fusion device. The document states that "No additional testing has been performed for the Spineart Tryptik® Ti line extension spinal implants." and relies on an "engineering rationale" to support substantial equivalence to a previously cleared version of the same device and other predicate devices.

Therefore, the provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It explicitly states that no additional testing was performed for this particular submission.

The document focuses on demonstrating substantial equivalence to predicate devices based on:

Technological characteristics: The device uses the same manufacturing technology (additive manufacturing - SLM) and material (medical grade titanium alloy conforming to ASTM F136 and ASTM F3001) as the primary predicate device.
Design features: The device presents similar design features and range of devices, and is designed for the same anterior approach as the previously cleared Tryptik® Ti spinal implants.
Indications for use: The indications for use are identical to the predicate device.

The document also mentions that non-clinical tests (Static axial compression, Static shear compression, Static torsion according to ASTM F2077 and subsidence testing according to ASTM F2267) were conducted on the predicate devices, not this current submission.

**Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance
Sample sized used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Adjudication method
If a multi reader multi case (MRMC) comparative effectiveness study was done
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established**

as this information is not present in the provided text. The submission relies on prior testing of predicate devices and an engineering rationale for substantial equivalence.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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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	SPINEART3 Chemin du Pré-Fleuri1228 PLAN LES OUATESGENEVA SWITZERLAND
Contacts	Franck PENNESI Chief Technical OfficerPhone : +41 22 570 1200 Fax : +41 22 594 8306Mail : fpennesi@spineart.comRegulatory contact : Estelle LEFEUVRE elefeuvre@spineart.com
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 SpineartAdditional 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 patientswith degenerative disc disease (DDD) of the cervical spine withaccompanying radicular symptoms at one level or two contiguous disclevels from C2 to T1 disc. DDD is defined as discogenic pain withdegeneration of the disc confirmed by patient history and radiographicstudies. TRYPTIK®Ti cages are used to facilitate intervertebral bodyfusion in the cervical spine using autogenous and/or allogeneic bonegraft comprised of cancellous and/or corticocancellous bone graft.TRYPTIK®Ti cages are to be used with supplemental fixation that hasbeen cleared for use in the cervical spine. Patients should have at leastsix (6) weeks of non-operative treatment prior to treatment with anintervertebral cage.

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Description of the device	Spineart Tryptik® Ti spinal implants consist in a range of intervertebralbody spacers with various shapes and designs so as to be implanted viaan anterior cervical approach and to adapt different patient's conditions.The Tryptik® Ti spacers are all made from medical grade titanium alloyconforming to ASTM F136 standard and are produced by additivemanufacturing (SLM) according to ASTM F3001. Subsequently thespacer is machined (thread tapping) and polished.The subject implants Tryptik® Ti will extend the previously clearedTryptik® Ti range of implants (K200312) which presents similar designfeatures and the same manufacturing technology, i.e. additivemanufacturing (SLM), and join the previously cleared Tryptik® Ti rangeof implants (K200312) which addresses the same indications and utilizethe same instrumentation designed purposely.The Tryptik® Ti spinal implants are delivered sterile (gamma sterilization)and supplied with dedicated surgical instruments (reusable – providednon-sterile).
Technologicalcharacteristicscompared to thepredicate devices	The Tryptik® Ti spinal implants are manufactured using the samemanufacturing technology, i.e. additive manufacturing (SLM) aspredicate device Tryptik® Ti. The characterization of the chemical,physical and mechanical properties of the material was performed inaccordance with ASTM F3001 and ASTM E8/E8M.The Tryptik® Ti spinal implants present a similar design feature andrange of devices as the previously cleared Tryptik® Ti spinal implants.Both Tryptik® Ti and Tryptik® Ti extension line are designed for ananterior approach.The following non-clinical tests were conducted on predicate devices:Static axial compression, Static shear compression, Static torsionaccording to ASTM F2077 and subsidence testing according to ASTMF2267. A engineering rationale has been provided to support substantialequivalence.
Discussion of Testing	No additional testing has been performed for the Spineart Tryptik® Ti lineextension spinal implants.
Conclusion	Based on the design features, technological characteristics, featurecomparisons, and indications for use, Tryptik® Ti line extension hasdemonstrated substantial equivalence to the identified predicate devices.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
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.(b)
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.