(56 days)
Not Found
No
The document describes a physical implant and its mechanical properties, with no mention of software, algorithms, or data processing related to AI/ML.
Yes.
The device is indicated for use in patients with degenerative disc disease with accompanying radicular symptoms and is used to facilitate intervertebral body fusion, describing a therapeutic purpose.
No
Explanation: This device is an implantable fusion system (a therapeutic device) used to treat degenerative disc disease, not to diagnose it. While diagnosis of the condition is mentioned as part of the patient history and radio review, the device itself doesn't perform diagnostic functions.
No
The device description explicitly states it consists of "additively manufactured interbody devices and machined titanium bone screws," which are physical hardware components.
Based on the provided information, 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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The Tailored-H Cervical Stand-Alone system is an implantable medical device designed to provide mechanical support and facilitate fusion in the cervical spine. It is surgically implanted into the patient's body.
- No mention of testing biological samples: The description focuses on the device's physical properties, materials, and surgical application. There is no indication that it is used to analyze biological samples.
Therefore, the Tailored-H Cervical Stand-Alone system falls under the category of an implantable surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Tailored-H Cervical Stand-Alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radios. The Tailored-H Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) using autograft bone. Patients should have at least six (6) weeks of nonoperative treatment. The Tailored-H Cervical Stand-Alone Interbody Fusion System is intended to be used with the bone screw fixation provided and requires no additional fixation.
Product codes
OVE
Device Description
The Tailored-H Cervical Stand-Alone System is an internal spinal fixation system consisting of additively manufactured interbody devices and machined titanium bone screws. It is designed to provide mechanical support to the cervical spine while arthrodesis occurs. The Tailored-H Cervical Stand-Alone System is available in a variety of lordosis and footprint options with a porous architecture to offer increased capacity for bone growth and mechanical properties to suit the individual pathology and anatomical conditions of the patient.
The Tailored-H cages are additively manufactured from titanium alloy Ti-6Al-4V ELI per ASTM F3001. The fixation screws and face plates are machined from titanium alloy Ti-6Al-4V ELI per ASTM F136 and ISO 5832-3.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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-H Cervical Stand-Alone 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-H Cervical Stand-Alone 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)
K200543, K211111, K212853, K200458
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
Image /page/0/Picture/0 description: The image contains 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 is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
November 18, 2022
BeSpoke Technologies, LLC % Mr. Nathan Wright, MS Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K222903
Trade/Device Name: Tailored-H Cervical Stand Alone System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: September 23, 2022 Received: September 23, 2022
Dear Mr. 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
1
542 of the Act); 21 CFR 1000-1050.
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 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 (QS) 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-
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,
Brent Showalter -S
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
Indications for Use
510(k) Number (if known) K222903
Device Name Tailored-H Cervical Stand-Alone System
Indications for Use (Describe)
The Tailored-H Cervical Stand-Alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radios. The Tailored-H Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) using autograft bone. Patients should have at least six (6) weeks of nonoperative treatment. The Tailored-H Cervical Stand-Alone Interbody Fusion System is intended to be used with the bone screw fixation provided and requires no additional fixation.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
5.510(K) SUMMARY
| Submitter's Name: | BeSpoke Technologies |
|---|---|
| Submitter's Address: | 118 S. Cherry Street, Suite E |
| Winston-Salem, North Carolina 27101 | |
| Submitter's Telephone: | 314-494-0313 |
| Contact Person: | Nathan Wright MS |
| Empirical Technologies | |
| 1-719-351-0248 | |
| nwright@empiricaltech.com | |
| Image: Empirical Technologies logo | |
| Date Summary was Prepared: | September 23, 2022 |
| Trade or Proprietary Name: | Tailored-H Cervical Stand-Alone System |
| Common or Usual Name: | Intervertebral Fusion Device with Integrated Fixation, Cervical |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | OVE |
| Classification Panel: | Orthopedic Devices - Spinal Devices (DHT6B) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Tailored-H Cervical Stand-Alone System is an internal spinal fixation system consisting of additively manufactured interbody devices and machined titanium bone screws. It is designed to provide mechanical support to the cervical spine while arthrodesis occurs. The Tailored-H Cervical Stand-Alone System is available in a variety of lordosis and footprint options with a porous architecture to offer increased capacity for bone growth and mechanical properties to suit the individual pathology and anatomical conditions of the patient.
The Tailored-H cages are additively manufactured from titanium alloy Ti-6Al-4V ELI per ASTM F3001. The fixation screws and face plates are machined from titanium alloy Ti-6Al-4V ELI per ASTM F136 and ISO 5832-3.
INDICATIONS FOR USE
The Tailored-H Cervical Stand-Alone System is a stand-alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Tailored-H Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) using autograft bone. Patients should have at least six (6) weeks of nonoperative treatment prior to treatment. The Tailored-H Cervical Stand-Alone Interbody Fusion System is intended to be used with the bone screw fixation provided and requires no additional fixation.
TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are the same or similar between the subject and predicates:
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- Indications for Use ●
- Materials of Manufacture ●
- Structural Support Mechanism and Lattice Structure ●
- Sterility ●
- Cage Sizes ●
- Screw Sizes ●
- Screw anti-backout feature ●
- Manufacturing and Biocompatibility ●
There are no differences between the subject and predicates that introduce concerns for safety and effectiveness of the subject device. The subject offers larger diameter screws which do not introduce a concern for the safety and effectiveness of the subject device because it increases the larger diameter increases the strength of the fixation screws.
Predicate Devices
| 510k
Number | Trade or Proprietary or Model Name | Manufacturer | Product
Code | Predicate
Type |
|----------------|-----------------------------------------------|-------------------------|-----------------|-------------------|
| K200543 | Nexxt Matrixx® Stand Alone Cervical-TL System | Nexxt Spine, LLC | OVE | Primary |
| K211111 | SureMAX-SA Cervical Standalone System | Additive Implants, Inc. | OVE | Additional |
| K212853 | Cervical Stand-Alone System | Eminent Spine, LLC | OVE | Additional |
| K200458 | Tailored-C Cervical Interbody Fusion System | BeSpoke Technologies | ODP | Additional |
PERFORMANCE DATA
The Tailored-H Cervical Stand-Alone 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-H Cervical Stand-Alone 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-H Cervical Stand-Alone System is substantially equivalent to the predicate device.