K Number
K233191
Device Name
TotalTi ACDF by SAGICO
Date Cleared
2023-11-21

(54 days)

Product Code
Regulation Number
888.3080
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TotalTi ACDF by SAGICO is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radios. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The TotalTi ACDF by SAGICO is to be filled with autogenous bone graft material and implanted via an open anterior approach and deployment of the internal blades. The TotalTi ACDF by SAGICO is designed in a manner to be used with the additional fixation (e.g. anterior plate or cervical pedicle screws) cleared by the FDA to properly utilize this device.
Device Description
The TotalTi ACDF by SAGICO, is a spinal system of Interbody Fusion (IBF) devices used to provide structural stability in skeletally mature individuals following discectomy. The TotalTi ACDF by SAGICO, is intended to be used between two contiguous levels from C2 to T1 and placed via an open anterior surgical approach. The implants are customizable additively manufactured and available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The TotalTi ACDF by SAGICO, incorporates a vertical cavity (a large central hollowed window) designed to be packed with and filled with autogenous bone graft material to promote fusion. The TotalTi ACDF by SAGICO implant requires the internal fixation blades to be deployed and is designed to be used with FDA cleared supplemental fixation to properly utilize the device. The TotalTi ACDF by SAGICO implants features protrusions located on the top and bottom surfaces to engage with superior and inferior endplates of the adjacent vertebrae to resist rotational and expulsion. MATERIALS: The TotalTi ACDF by SAGICO are additively manufactured implants from titanium alloy Ti-6Al-4V ELI. The TotalTi ACDF by SAGICO includes additively manufactured spacer, integrated fixation anchors per ASTM F3001and traditionally machined titanium alloy anchors lock per ASTM F136. FUNCTION: The TotalTi ACDF by SAGICO implants are intervertebral body fusion devices to help restore integrity to the spine in the cervical region.
More Information

Not Found

No
The 510(k) summary describes a physical interbody fusion device made of titanium alloy. There is no mention of software, algorithms, or any computational components that would suggest the use of AI or ML. The performance studies are based on mechanical testing of the device's structural integrity.

Yes
The device is intended to provide structural stability and promote fusion in patients with degenerative disc disease, which qualifies it as a therapeutic device.

No
The device described is an interbody fusion device designed to provide structural stability in the spine, not to diagnose a condition.

No

The device description explicitly states it is a spinal system of Interbody Fusion (IBF) devices, which are physical implants made of titanium alloy. It describes the physical characteristics, materials, and function of the implant, indicating it is a hardware device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
  • Device Description: The TotalTi ACDF by SAGICO is an implantable medical device designed to be surgically placed in the cervical spine to promote bone fusion. It is a physical structure used within the body, not a tool for analyzing biological samples.
  • Intended Use: The intended use clearly describes a surgical procedure and the device's role in providing structural stability and promoting fusion within the spine. It does not involve the analysis of biological specimens.

Therefore, the TotalTi ACDF by SAGICO falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

The TotalTi ACDF by SAGICO is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from (C2-T ). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radios. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The TotalTi ACDF by SAGICO is to be filled with autogenous bone graft material and implanted via an open anterior approach and deployment of the internal blades. The TotalTi ACDF by SAGICO is designed in a manner to be used with the additional fixation (e.g. anterior plate or cervical pedicle screws) cleared by the FDA to properly utilize this device.

Product codes

OVE

Device Description

The TotalTi ACDF by SAGICO, is a spinal system of Interbody Fusion (IBF) devices used to provide structural stability in skeletally mature individuals following discectomy. The TotalTi ACDF by SAGICO, is intended to be used between two contiguous levels from C2 to T1 and placed via an open anterior surgical approach. The implants are customizable additively manufactured and available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The TotalTi ACDF by SAGICO, incorporates a vertical cavity (a large central hollowed window) designed to be packed with and filled with autogenous bone graft material to promote fusion. The TotalTi ACDF by SAGICO implant requires the internal fixation blades to be deployed and is designed to be used with FDA cleared supplemental fixation to properly utilize the device. The TotalTi ACDF by SAGICO implants features protrusions located on the top and bottom surfaces to engage with superior and inferior endplates of the adjacent vertebrae to resist rotational and expulsion.

MATERIALS: The TotalTi ACDF by SAGICO are additively manufactured implants from titanium alloy Ti-6Al-4V ELI. The TotalTi ACDF by SAGICO includes additively manufactured spacer, integrated fixation anchors per ASTM F3001and traditionally machined titanium alloy anchors lock per ASTM F136.

FUNCTION: The TotalTi ACDF by SAGICO implants are intervertebral body fusion devices to help restore integrity to the spine in the cervical region.

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)

Non-clinical performance data testing conducted to support substantial equivalence for the TotalTi ACDF by SAGICO includes:
ASTM F2077
Standard Test Methods for Intervertebral Body Fusion Devices Static and Dynamic Compression Test Static and Dynamic Compression Shear Test Static and Dynamic Torsion Test
ASTM F2267-04
Subsidence - Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device under Static Axial Compression
OTHER ADDITIONAL TESTING
Static Axial Pullout Test, Strength of Cage with Blade, Expulsion Static Push-Out test, Strength of Deployment of Spin Blade, Effect of Anchors Deployment

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K221138, K161710, K091088, K180401

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.

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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.

November 21, 2023

Spinal Analytics & Geometrical Implant Co, LLC James J. Gibson, Jr., Ph.D., CPA 2189 W Busch Blvd Tampa, Florida 33612

Re: K233191

Trade/Device Name: TotalTi ACDF by SAGICO Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: September 27, 2023 Received: September 28, 2023

Dear Dr. Gibson:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

1

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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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Indications for Use

510(k) Number (if known) K233191

Device Name TotalTi ACDF by SAGICO

Indications for Use (Describe)

The TotalTi ACDF by SAGICO is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from (C2-T ). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radios. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The TotalTi ACDF by SAGICO is to be filled with autogenous bone graft material and implanted via an open anterior approach and deployment of the internal blades. The TotalTi ACDF by SAGICO is designed in a manner to be used with the additional fixation (e.g. anterior plate or cervical pedicle screws) cleared by the FDA to properly utilize this device.

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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Image /page/3/Picture/0 description: The image is a logo for SAGICO, which stands for Spinal Analytics & Geometrical Implants Co. The logo features the company name in bold, sans-serif font, with "SAGICO" in a larger font size than "SPINAL ANALYTICS & GEOMETRICAL IMPLANTS CO." The text is placed in front of a blue hexagon shape that has a stylized "S" in the center. The overall design is modern and professional, suggesting a company focused on innovation and precision in the medical field.

510(k) Executive Summary

Device Trade Name(s):TotalTi ACDF by SAGICO
Classification Panel:Orthopedics
Class and Reference:Class II
Product Code(s):OVE
Classification Name(s):Intervertebral Body Fusion Device
Regulation Number(s):21 CFR 888.3080
Applicant/Official Contact Person:James Gibson, PhD, CPA
Email:JG@SAGICO.com
Submitter /Manufacturer:Spinal Analytics & Geometrical Implant
Co, LLC (dba/ SAGICO)
2189 West Busch Blvd
Tampa, Florida 33612
Tel. (813) 830-3636
Preparation Date:November 20, 2023

Purpose of Submission:

The purpose of this submission is to request new and separate clearance for the ACDF implant known as the "TotalTi ACDF by SAGICO".

4

PRIMARY PREDICATE AND ADDITIONAL PREDICATE DEVICES:

| Legally Marketed
Predicate Device | Distributor/Manufacture
Name | Regulatory Class and
Product Code | 510(K) Registration
Number |
|-----------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------|-------------------------------|
| PRIMARY PREDICATE
TITUS TITANIUM
CERVICAL BY SAGICO | SAGICO VA USA, LLC | OVE | K221138 |
| Additional Predicates
SAGICO IBF System | Spinal Analytics &
Geometrical Implant Co,
LLC (dba/ SAGICO) | OVE | K161710 |
| LDR Spine Cervical
Interbody Fusion System | LDR Spine | OVE | K091088 |
| TiWAVE-C Porous
Titanium Cervical Cage | Kalitec Direct, LLC | OVE | K180401 |

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Image /page/5/Picture/0 description: The image shows the logo for SAGICO, which stands for Spinal Analytics & Geometrical Implants Co. The logo features the company name in bold, dark blue letters above the full name of the company in smaller letters. The logo is set against a dark blue hexagon shape that has a stylized letter 'S' incorporated into the design. The overall design is modern and professional.

DEVICE DESCRIPTION:

The TotalTi ACDF by SAGICO, is a spinal system of Interbody Fusion (IBF) devices used to provide structural stability in skeletally mature individuals following discectomy. The TotalTi ACDF by SAGICO, is intended to be used between two contiguous levels from C2 to T1 and placed via an open anterior surgical approach. The implants are customizable additively manufactured and available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The TotalTi ACDF by SAGICO, incorporates a vertical cavity (a large central hollowed window) designed to be packed with and filled with autogenous bone graft material to promote fusion. The TotalTi ACDF by SAGICO implant requires the internal fixation blades to be deployed and is designed to be used with FDA cleared supplemental fixation to properly utilize the device. The TotalTi ACDF by SAGICO implants features protrusions located on the top and bottom surfaces to engage with superior and inferior endplates of the adjacent vertebrae to resist rotational and expulsion.

MATERIALS: The TotalTi ACDF by SAGICO are additively manufactured implants from titanium alloy Ti-6Al-4V ELI. The TotalTi ACDF by SAGICO includes additively manufactured spacer, integrated fixation anchors per ASTM F3001and traditionally machined titanium alloy anchors lock per ASTM F136.

FUNCTION: The TotalTi ACDF by SAGICO implants are intervertebral body fusion devices to help restore integrity to the spine in the cervical region.

INDICATIONS FOR USE:

The TotalTi ACDF by SAGICO is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The TotalTi ACDF by SAGICO is to be filled with autogenous bone graft material and implanted via an open anterior approach and deployment of the internal blades. The TotalTi ACDF by SAGICO is designed in a manner to be used with the additional fixation (e.g. anterior plate or cervical pedicle screws) cleared by the FDA to properly utilize this device.

6

NON-CLINICAL PERFORMANCE DATA:

Non-clinical performance data testing conducted to support substantial equivalence for the TotalTi ACDF by SAGICO includes:

ASTM F2077

Standard Test Methods for Intervertebral Body Fusion Devices Static and Dynamic Compression Test Static and Dynamic Compression Shear Test Static and Dynamic Torsion Test

ASTM F2267-04

Subsidence - Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device under Static Axial Compression

OTHER ADDITIONAL TESTING

Static Axial Pullout Test, Strength of Cage with Blade, Expulsion Static Push-Out test, Strength of Deployment of Spin Blade, Effect of Anchors Deployment

SUBSTANTIAL EQUIVALENCE CONCLUSION:

The TotalTi ACDF by SAGICO implants are similar to legally marketed and FDA 510(k) Cleared predicate devices with respect to design, indication for use, performance and technical characteristics.

The information provided within this premarket notification supports substantial equivalence of the TotalTi ACDF by SAGICO implants to the cited predicate devices.