The Kuros TLIF Cage is intended for use in intervertebral body fusion of the Kuros TLIF cage is inserted via a posterior approach and can be used in one level or two contiguous levels of the lumbar spine (L1 to S1). The Kuros TLIF cage is designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion, and is to be used with supplemental posterior spinal fixation systems for use in the lumbar spine that are cleared by the FDA.

The Kuros TLIF cage is intended for the treatment of patients with Degenerative Disk Disease (DDD) with up to grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must be skeletally mature and have had at least six months of non-operative treatment.

Device Description

The Kuros TLIF Cage is an implant interbody fusion surgery and is used to restore intervertebral height and facilitate intervertebral body fusion in the spine. The Kuros TLIF Cage is inserted via a posterior (transforaminal) approach and can be used in one level or two contiguous levels of the lumbar spine (L1 to S1). The Kuros TLIF cage is designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and should be used in combination with supplemental posterior spinal fixation systems, intended for use in the lumbar spine and cleared by the FDA.

The Kuros TLIF cage is a rigid spacer, manufactured from PEEK Optima LT1 per ASTM F2026 to maximize biocompatibility, durability, and robustness. The design includes tantalum markers for imaging and has a hollow geometry, allowing the cage to be packed with grafting material per the indications for use. The Kuros TLIF Cages are available in various lengths, and angle variants to accommodate patient anatomy, and are supplied with their specific instrumentation. The device is intended to be used by orthopedic surgeons or neurosurgeons working in a hospital who are trained to use these devices in the patient population specified in the indications for use. The implants are provided sterile to the hospital.

AI/ML Overview

The provided text describes the Kuros TLIF Cage, an intervertebral body fusion device. It details the device's indications for use, description, and comparison to predicate devices, but it does not contain any information about acceptance criteria, device performance metrics, or a study reporting on these metrics.

The document is a 510(k) summary from the FDA, which focuses on demonstrating substantial equivalence to previously cleared predicate devices.

Here's what can be extracted from the document regarding the device and its evaluation, but it explicitly states "No clinical data has been presented." and therefore cannot fulfill most of the request:

Device Name: Kuros TLIF Cage
Regulation Number: 21 CFR 888.3080
Regulation Name: Intervertebral Body Fusion Device
Regulatory Class: Class II
Product Code: MAX

Indications for Use:
The Kuros TLIF Cage is intended for use in intervertebral body fusion of one or two contiguous levels of the lumbar spine (L1 to S1). It is inserted via a posterior approach and designed for use with autograft and/or allograft (cancellous and/or corticocancellous bone graft) to facilitate fusion. It must be used with supplemental posterior spinal fixation systems cleared by the FDA.

It is intended for the treatment of patients with Degenerative Disk Disease (DDD) with up to grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must be skeletally mature and have had at least six months of non-operative treatment.

Description of the Device:
The Kuros TLIF Cage is a rigid spacer made from PEEK Optima LT1 (ASTM F2026). It includes tantalum markers for imaging and has a hollow geometry to be packed with grafting material. It is available in various lengths and angle variants and is supplied with specific instrumentation. The implants are provided sterile.

Summary of Performance Data (as presented in the document):
The Kuros TLIF Cage conforms to the "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device - Document issued on: June 12, 2007."
Worst-case devices were subjected to mechanical testing, including:

Static axial compression
Dynamic axial compression
Static compression shear
Dynamic compression shear
Subsidence testing (according to ASTM F2267)
Expulsion testing (according to Endolab protocol)

Results: "Results demonstrate comparable (or better) mechanical properties to the predicate devices."

Crucially, the document explicitly states: "No clinical data has been presented."

Given this information, it is impossible to complete a table of acceptance criteria and reported device performance from this document for the requested metrics as clinical performance data is absent. The acceptance criteria here are related to mechanical properties in comparison to predicate devices, not clinical outcomes.

Therefore, for your specific request:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Mechanical): Conformity to "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device - Document issued on: June 12, 2007." and mechanical properties comparable to or better than predicate devices across tested parameters (static/dynamic axial compression, static/dynamic compression shear, subsidence, expulsion).
- Reported Device Performance (Mechanical): The Kuros TLIF Cage demonstrated "comparable (or better) mechanical properties to the predicate devices" for the tested parameters.
- Clinical Performance: Not reported in this document.
Sample size used for the test set and the data provenance: Not applicable for clinical data, as "No clinical data has been presented." For mechanical testing, specific sample sizes are not provided, only that "Worst case devices were subjected to mechanical testing."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as "No clinical data has been presented."
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as "No clinical data has been presented."
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as "No clinical data has been presented" and this device is a physical implant, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical testing, the ground truth would be established by the ASTM standards (ASTM F2077, ASTM F2267) and the Endolab protocol. For clinical performance, no ground truth is discussed as no clinical data was presented.
The sample size for the training set: Not applicable, as this is a physical medical device and no clinical "training set" of data is mentioned.
How the ground truth for the training set was established: Not applicable for the same reasons as above.

Summary

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Kuros Biosciences BV % Tess van Dam Clinical Evaluation Specialist BAAT Medical Products BV Floris Hazemeijerstraat 800 7555 RJ Hengelo The Netherlands

Re: K183092

Trade/Device Name: Kuros TLIF Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: January 28, 2019 Received: January 31, 2019

Dear Tess van Dam:

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 mav, 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 avare 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

March 8, 2019

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requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Katherine D. Kavlock -S

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183092

Device Name Kuros TLIF Cage

Indications for Use (Describe)

The Kuros TLIF Cage is intended for use in intervertebral body fusion of the Kuros TLIF cage is inserted via a posterior approach and can be used in one levels of the lumbar spine (L1 to S1). The Kuros TLF cage is designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion, and is to be used with supplemental posterior systems for use in the lumbar spine that are cleared by the FDA.

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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4. Traditional 510(k) Summary

Date of preparation: January, 28, 2019

2. Applicant:

Kuros Biosciences BV Prof. Bronkhorstlaan 10 Building 48, 3723 MB Bilthoven The Netherlands

3. Application correspondent:

BAAT Medical Products B.V. Creatieve Fabriek – Building A04 F. Hazemeijerstraat 800 7555 RJ Hengelo The Netherlands

Contact Person:

Tess van Dam, Clinical Evaluation Specialist Office: +31-(0)88-5656600 Direct: +31-(0)88-5656624 Mobile: + 31-(0)6-30395804 Email: tess@baatmedical.com

4. Device Information

Trade Name:	Kuros TLIF Cage
510(k) Number:	K183092/S001
Classification name:	Intervertebral Fusion Device With Bone Graft, Lumba
Regulation number:	21 CFR §888.3080
Regulation Description:	Intervertebral body fusion device
Regulatory Class:	II
Product Code:	MAX
Panel:	Orthopedic

5. Indications for Use

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6. Description of the Device

7. Predicate Device(s)

The Kuros TLIF Cage is substantially equivalent to the following devices:

. K153783 Spinevision Spacevision TLIF (primary predicate)
Tyber Medical TLIF Cage (additional predicate) K130573
K182746 Alphatec Spine ATEC ALIF and LLIF Spacer System (additional predicate)
K170503 EIT Spine TLIF Cage (additional predicate)

8. Summary of Performance Data

The Kuros TLIF Cage conforms to Class II Special Controls Guidance Document: Intervertebral Body Fusion Device- Document issued on: June 12, 2007. Worst case devices were subjected to mechanical testing. Mechanical testing included:

Static axial compression, dynamic axial compression, static compression shear, dynamic compression shear, performed according to ASTM F2077
. Subsidence testing performed according to ASTM F2267
Expulsion testing performed according to Endolab protocol

Results demonstrate comparable (or better) mechanical properties to the predicate devices. No clinical data has been presented.

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9. Substantial Equivalence Conclusion

The Kuros TLIF Cage is demonstrated to be substantially equivalent to the primary and additional predicates cited above, in terms of intended use, material, design, mechanical properties and function.

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.