(307 days)
Not Found
No
The summary describes a physical implant and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used to facilitate intervertebral body fusion in the cervical spine to treat degenerative disc disease, which is a medical condition.
No
The device is an implant used to facilitate intervertebral body fusion, not to diagnose a condition. Its function is mechanical support during arthrodesis.
No
The device description clearly states it is an "intervertebral spinal fixation system comprised of additively manufactured cervical interbody spacers" made from Ti-6A1-4V, which are physical implants, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided text describes a physical implant (Tailored-C Cervical Interbody Fusion Devices) that is surgically placed into the cervical spine to facilitate fusion. It is a structural device, not a diagnostic test.
- Intended Use: The intended use is to treat degenerative disc disease by providing mechanical support and facilitating fusion, not to diagnose a condition or provide information about a patient's health through testing of samples.
The device is a surgical implant used for treatment, not a diagnostic tool.
N/A
Intended Use / Indications for Use
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.
Product codes
ODP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic studies
Anatomical Site
Cervical spine (C2-T1)
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K162496, K173347, K120275, K170318
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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)
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.
| 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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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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5.510(K) SUMMARY
| Submitter's Name: | BeSpoke Technologies |
|---|---|
| Submitter's Address: | 118 S. Cherry St, Suite E |
| Winston-Salem, NC 27101 | |
| Submitter's Telephone: | 314-494-0313 |
| Contact Person: | Nathan Wright MS |
| Empirical Testing Corp. | |
| 719-351-0248 | |
| nwright@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:
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.
INDICATIONS FOR USE
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.
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
4
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 or
Model Name | Manufacturer | Predicate
Type |
|-------------|---------------------------------------------------|-------------------|-------------------|
| K162496 | FoundationTM 3D Interbody | CoreLink LLC | Primary |
| K173347 | ACTLIF C FLXTM | Centinel Spine | Additional |
| K120275 | Synthes ACIS | Synthes (USA) LLC | Additional |
| K170318 | NeoFuseTM Ti3D
PLIF/TLIF/Cervical
Interbody | 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.