The Tailored-C Cervical Interbody Fusion Devices 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. Tailored-C Cervical implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at one disc level (C2-T1) using autograft bone. Tailored-C Cervical implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Device Description

The Tailored-C Cervical Interbody Fusion System is an intervertebral spinal fixation system comprised of additively manufactured cervical interbody spacers. They are designed to provide mechanical support to the cervical spine while arthrodesis occurs. The implant has a partially porous construction and an open architecture with a large variety of footprints and lordosis angles to optimize patient fit. The footprints are offered at 11x13mm, 12x14mm, 14x16mm, 16x18mm, and 17x19mm. The lordosis is offered at 0°, 4°, and 7°. The height ranges from 5mm to 12mm in 1mm increments. All implant components are manufactured from Ti-6A1-4V per ASTM F3001.

AI/ML Overview

This FDA 510(k) summary describes a physical medical device (an intervertebral fusion system), not a software or AI-based device. Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), and training set information is not applicable.

The document discusses the mechanical performance testing of the Tailored-C Cervical Interbody Fusion System. Here's a breakdown of the relevant performance data and conclusion provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative table format with corresponding reported values. Instead, it lists the types of performance tests conducted and generally states that the results show the device is "sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

Test Mode (per ASTM standard)	General Reported Performance
Static Axial Compression (F2077)	Strength is sufficient for intended use and substantially equivalent to predicate devices.
Static Compression Shear (F2077)	Strength is sufficient for intended use and substantially equivalent to predicate devices.
Static Torsion (F2077)	Strength is sufficient for intended use and substantially equivalent to predicate devices.
Subsidence (F2267)	Strength is sufficient for intended use and substantially equivalent to predicate devices.
Dynamic Axial Compression (F2077)	Strength is sufficient for intended use and substantially equivalent to predicate devices.
Dynamic Compression Shear (F2077)	Strength is sufficient for intended use and substantially equivalent to predicate devices.
Dynamic Torsion (F2077)	Strength is sufficient for intended use and substantially equivalent to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. This is a mechanical device, and testing involves physical samples of the device itself rather than data from human subjects. The testing standards are ASTM F2077 and F2267, which are international standards for intervertebral body fusion device testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. Ground truth, in the context of AI/software, refers to verified labels or diagnoses. For a mechanical device, performance is measured against engineering specifications and industry standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. Adjudication is relevant for human interpretation or labeling tasks, not for mechanical testing.

5. 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. This is a physical interbody fusion system, not an AI or imaging device involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable in the AI/software sense. The "ground truth" for mechanical testing would be the established engineering specifications and performance requirements defined by standards like ASTM F2077 and F2267, against which the device's physical performance is measured.

8. The sample size for the training set:

Not applicable. This is a mechanical device, not an AI system that requires a "training set."

9. How the ground truth for the training set was established:

Not applicable.

In summary: The provided text details the mechanical testing performed on the Tailored-C Cervical Interbody Fusion System to demonstrate its substantial equivalence to predicate devices, focusing on its physical strength and durability according to established ASTM standards. The concepts of AI/software performance evaluation requested in the prompt do not apply to this type of medical device submission.

Summary

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December 28, 2020

Image /page/0/Picture/1 description: The image shows 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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

BeSpoke Technologies % Nathan Wright Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K200458

Trade/Device Name: Tailored-C Cervical Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: December 1, 2020 Received: December 2, 2020

Dear Nathan Wright:

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 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

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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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for

Brent Showalter, Ph.D. 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Food and Drug Administration Expiration Date: 06/30/2020 See PRA Statement on last page. Indications for Use 510(k) Number (if known) K200458 Device Name

Tailored-C Cervical Interbody Fusion System

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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5.510(K) SUMMARY

Submitter's Name:	BeSpoke Technologies
Submitter's Address:	118 S. Cherry St, Suite EWinston-Salem, NC 27101
Submitter's Telephone:	314-494-0313
Contact Person:	Nathan Wright MSEmpirical Testing Corp.719-351-0248nwright@empiricaltech.com
Date Summary was Prepared:	21-Feb-2020
Trade or Proprietary Name:	Tailored-C Cervical Interbody Fusion System
Common or Usual Name:	Intervertebral Fusion Device with Bone Graft, Cervical
Classification:	Class II per 21 CFR §888.3080
Product Code:	ODP
Classification Panel:	Division of Orthopedic Devices

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

All implant components are manufactured from Ti-6A1-4V per ASTM F3001.

INDICATIONS FOR USE

TECHNOLOGICAL CHARACTERISTICS

The Tailored-C Cervical Interbody Fusion System is made from titanium alloy that conforms to ASTM F3001. The subject and predicate devices have nearly identical technological

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characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:

Indications for Use
Materials of manufacture .
Structural support mechanism ●
Sizes ●

Table 5-1 Predicate Devices

510k Number	Trade or Proprietary orModel Name	Manufacturer	PredicateType
K162496	FoundationTM 3D Interbody	CoreLink LLC	Primary
K173347	ACTLIF C FLXTM	Centinel Spine	Additional
K120275	Synthes ACIS	Synthes (USA) LLC	Additional
K170318	NeoFuseTM Ti3DPLIF/TLIF/CervicalInterbody	HT Medical, LLC	Additional

PERFORMANCE DATA

The Tailored-C Cervical Interbody Fusion System has been tested in the following test modes:

Static Axial Compression per ASTM F2077 ●
Static Compression Shear per ASTM F2077 ●
Static Torsion per ASTM F2077 ●
Subsidence per ASTM F2267 ●
. Dynamic Axial Compression per ASTM F2077
. Dynamic Compression Shear per ASTM F2077
. Dynamic Torsion per ASTM F2077

The results of this non-clinical testing show that the strength of the Tailored-C Cervical Interbody Fusion System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Tailored-C Cervical Interbody Fusion System is substantially equivalent to the predicate device.

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.