(129 days)
Not Found
No
The summary describes a physical implant (cervical interbody cage) and its mechanical properties and testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used to facilitate intervertebral body fusion in the cervical spine to treat degenerative disc disease, which involves addressing a medical condition.
No
Explanation: The device, Ti-Largo™ Cervical Interbody Cages, is an implant used for intervertebral body fusion in the cervical spine to treat degenerative disc disease. Its purpose is therapeutic and structural, not to diagnose a condition.
No
The device description clearly states that the device is a physical implant (cervical interbody cage) made of titanium alloy, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a surgical implant used to facilitate intervertebral body fusion in the cervical spine. This is a therapeutic and structural function within the body.
- Device Description: The description details a physical implant made of titanium alloy, designed to be surgically placed.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Performance Studies: The performance studies focus on mechanical properties and sterilization, which are relevant to a surgical implant, not a diagnostic device.
IVD devices are used in vitro (outside the body) to analyze samples like blood, urine, or tissue to provide diagnostic information. This device is used in vivo (inside the body) as a structural support.
N/A
Intended Use / Indications for Use
Ti-Largon™ Cervical Interbody Cages 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. Ti-Largo™ Cervical Interbody Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C2 to T 1 disc levels using autograft bone. Ti-Largo™ Cervical Interbody Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.
Product codes
ODP
Device Description
FloSpine Ti-Largo™ Cervical Interbody Cages are keystone shaped devices that have a central lumen and smaller graft windows throughout the structure of the implant. The implants are additively manufactured (ADM) using grade 23 titanium alloy powder per ASTM F3001. The implants are provided sterile (gamma radiation, 25 kGy minimum dose), are intended for single use only, and should not reused under any circumstances. Components from this system should not be used in conjunction with components from other company products.
Ti-Largo™ Cervical Interbody Cages are intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the cervical spine. The Ti-Largo™ Cervical Interbody System was developed for anterior cervical fusion with implants available in keystone shaped footprints ranging in size between 11 x 14mm and 16 x 18mm, thickness ranging from 5 to 14mm in 1 mm increments, 7degree lordosis for all sizes, and 0-degree lordosis for the smallest and largest sizes. The surface texture of the 3D structure of the implants resists expulsion forces.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, C2 to T1 disc levels
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 following tests were performed:
- Static Compression per ASTM 2077
- Dynamic Compression fatigue per ASTM F2077
- Static Torsion per ASTM 2077
- Dynamic Torsion fatigue per ASTM F2077
- Static Expulsion
- Subsidence per ASTM F2267
- Wear Debris Analysis
Sterilization validation with SAL of 10° is based on the VDmax method recommended by the ISO and AAMI (ANSI/AAMI/ISO 11137-1 and ANSI/AAMI/ISO 11137-2).
The data presented in this 510(k) notification show the Ti-Largo™ Cervical Interbody System to be substantially equivalent to the cited legally marketed predicate devices. It has the same or similar technological characteristics, materials, sizes, manufacturing processes, and principles of operation as the predicate devices. Therefore, The Ti-Largo™ Cervical Interbody System is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
FloSpine, LLC % Robert A. Poggie, Ph.D. President BioVera, Inc. 65 Promenade Saint Louis Notre-Dame -de-L`lle-Perrot, Quebec J7W3J6 Canada
Re: K223231
Trade/Device Name: Ti-Largo™ Cervical Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: January 24, 2023 Received: January 25, 2023
Dear Dr. Poggie:
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
1
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 531-542 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 Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
K223231
Device Name Ti-LargoTM Cervical Interbody System
Indications for Use (Describe)
Ti-Largon™ Cervical Interbody Cages 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. Ti-Largo™ Cervical Interbody Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C2 to T 1 disc levels using autograft bone. Ti-Largo™ Cervical Interbody Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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510(k) SUMMARY for the Ti-Largo™ Cervical Interbody System
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following information is a summary of safety and effectiveness of the Ti-Largo™ Cervical Interbody System.
A. SUBMITTERS INFORMATION
| Submitter Name: | BioVera, Inc. |
|---|---|
| Submitter Address: | 65 Promenade Saint-Louis, NDIP, Québec, J7W 3J6, CANADA |
| Contact Person: | Robert A. Poggie, PhD |
| Phone & Fax Number: | 514-901-0796 |
| Date of Submission: | October 18, 2022 |
B. DEVICE IDENTIFICATION & MANUFACTURER
| Manufacturer Name: | FloSpine, LLC |
|---|---|
| Manufacturer Address: | 3651 FAU Blvd, Suite 400 |
| Boca Raton, FL 33431 USA | |
| Registration Number: | 3010125671 |
| Contact Name: | Peter Harris |
| Title: | President / CEO |
| Device Trade Name: | Ti-Largo™™ Cervical Interbody System |
| Device Common Name: | Intervertebral body fusion device |
| Classification Name: | Intervertebral Body Fusion Device - Cervica |
| Classification Code: | ODP |
| Classification Panel: | Orthopedic |
| Regulation Number: | 21 CFR sections 888.3080 |
PRIMARY PREDICATE DEVICE
| K193255 | FloSpine Largo™ PEEK Interbody System |
|---|---|
| PREDICATE DEVICE | |
| K193359 | Additive Implants, Inc., SureMAX Family of Cervical Spacers |
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DEVICE DESCRIPTION
FloSpine Ti-Largo™ Cervical Interbody Cages are keystone shaped devices that have a central lumen and smaller graft windows throughout the structure of the implant. The implants are additively manufactured (ADM) using grade 23 titanium alloy powder per ASTM F3001. The implants are provided sterile (gamma radiation, 25 kGy minimum dose), are intended for single use only, and should not reused under any circumstances. Components from this system should not be used in conjunction with components from other company products.
Ti-Largo™ Cervical Interbody Cages are intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the cervical spine. The Ti-Largo™ Cervical Interbody System was developed for anterior cervical fusion with implants available in keystone shaped footprints ranging in size between 11 x 14mm and 16 x 18mm, thickness ranging from 5 to 14mm in 1 mm increments, 7degree lordosis for all sizes, and 0-degree lordosis for the smallest and largest sizes. The surface texture of the 3D structure of the implants resists expulsion forces.
INDICATIONS FOR USE
Ti-Largo™ Cervical Interbody Cages 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. Ti-Largo™ Cervical Interbody Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft bone. Ti-Largo™ Cervical Interbody Cages 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 Ti-Largo™ Cervical Interbody System has similar technological characteristics as the primary predicate and predicate devices, including the materials, design, function, range of sizes, manufacturing processes, surgical technique, and indications for use.
The indications for use for the subject and primary predicate devices are identical except for the tradename of the implant. The general shape, footprints, thickness, and lordosis options are the same or similar for the subject and predicate and devices; the additively manufactured titanium material is the same (ADM, grade 23 titanium alloy powder per F3001) to that of the predicate device. The minor differences in manufacturing and technology were assessed per the FDA guidance document for spinal devices with the outcomes of mechanical and physical testing all acceptance criteria and supportive of substantial equivalence.
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PERFORMANCE DATA
The following tests were performed:
-
- Static Compression per ASTM 2077
- Dynamic Compression fatigue per ASTM F2077 2.
-
- Static Torsion per ASTM 2077
- Dynamic Torsion fatigue per ASTM F2077 4.
-
- Static Expulsion
-
- Subsidence per ASTM F2267
-
- Wear Debris Analysis
Sterilization validation with SAL of 10° is based on the VDmax method recommended by the ISO and AAMI (ANSI/AAMI/ISO 11137-1 and ANSI/AAMI/ISO 11137-2).
CONCLUSIONS
The data presented in this 510(k) notification show the Ti-Largo™ Cervical Interbody System to be substantially equivalent to the cited legally marketed predicate devices. It has the same or similar technological characteristics, materials, sizes, manufacturing processes, and principles of operation as the predicate devices. Therefore, The Ti-Largo™ Cervical Interbody System is substantially equivalent to the predicate devices.