Titanium Interbody System

K253266 · Spine Innovation, LLC · MAX · Jan 8, 2026 · Orthopedic

Device Facts

• Record ID: K253266
• Device Name: Titanium Interbody System
• Applicant: Spine Innovation, LLC
• Product Code: MAX · Orthopedic
• Decision Date: Jan 8, 2026
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Titanium Interbody System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved level(s). The Titanium Interbody System is intended for use with autograft and is intended for use with supplemental fixation. Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the Titanium Interbody System.

Device Story

Expandable interbody fusion device; stabilizes spinal segments to promote fusion. Implanted during spinal surgery; used with autograft and supplemental fixation. Available in various sizes to accommodate patient anatomy. Sold sterile. Surgeon-operated.

Clinical Evidence

Bench testing only. Performed static and dynamic axial compression, static and dynamic shear compression, static torsion (ASTM F2077-18), and subsidence testing (ASTM F2267-04).

Technological Characteristics

Expandable interbody fusion device. Materials: porous titanium (ASTM F67), Ti-6Al-4V (ASTM F1472), and Ti-6Al-4V ELI (ASTM F136). Sold sterile. Mechanical stabilization principle.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous lumbar levels (L2-S1), including those with Grade 1 spondylolisthesis or retrolisthesis and prior non-fusion surgery. Requires six months of failed non-operative treatment. Used with autograft and supplemental fixation.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Spine Innovation Interbody System (K153356)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

January 8, 2026

Spine Innovation, LLC
Jude Paganelli
President
1330 Orange Ave., Suite 328
Coronado, California 92118

Re: K253266
Trade/Device Name: Titanium Interbody System
Regulation Number: 21 CFR 888.3080
Regulation Name: Intervertebral Body Fusion Device
Regulatory Class: Class II
Product Code: MAX
Dated: December 12, 2025
Received: December 12, 2025

Dear Jude Paganelli:

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"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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(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).

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 (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-reporting-combination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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K253266 - Jude Paganelli
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Sincerely,

KATHERINE D.
KAVLOCK-S

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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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This
textbox will be left blank for original applications/submissions. | K253266 | ? |
| Please provide the device trade name(s). | | ? |
| Titanium Interbody System | | |
| Please provide your Indications for Use below. | | ? |
| The Titanium Interbody System is indicated for spinal fusion procedures in skeletally mature patients with
degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is
defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and
radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the
involved levels. These patients may have had a previous non-fusion spinal surgery at the involved level(s).
The Titanium Interbody System is intended for use with autograft and is intended for use with supplemental
fixation. Patients must have undergone a regimen of at least six months of non-operative treatment prior to
being treated with the Titanium Interbody System. | | |
| Please select the types of uses (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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510(K) SUMMARY

SPONSOR: Spine Innovation LLC
1330 Orange Ave., Suite 328
Coronado, CA 92118
858-774-7891

CONTACT PERSON: Jude Paganelli
DATE PREPARED: September 29, 2025
TRADE NAME: Titanium Interbody System
COMMON NAME: Intervertebral Body Fusion Device
CLASSIFICATION NAME: Intervertebral Body Fusion Device (21 CFR 888.3080)
PRODUCT CODE: MAX

DEVICE DESCRIPTION:
The Titanium Interbody System is an expandable interbody fusion device and corresponding instruments intended to stabilize a spinal segment to promote fusion. The implant is sold sterile and is available in various sizes to accommodate varying patient anatomy.

MATERIALS:
The Titanium Interbody System implants are manufactured from porous titanium per ASTM F67 with reference to an authorised FDA Master File, and from titanium alloys (Ti-6Al-4V per ASTM F1472 and Ti-6Al-4V ELI per ASTM F136)

INDICATIONS FOR USE:
The Titanium Interbody System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2 to S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved level(s). The Titanium Interbody System is intended for use with autograft and is intended for use with supplemental fixation. Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the Titanium Interbody System.

PREDICATE DEVICE: Spine Innovation Interbody System (K153356)

TECHNOLOGICAL CHARACTERISTICS:
The Titanium Interbody System modification to the previously cleared Spine Innovation Interbody System (K153356) includes a change in implant material to titanium and a change

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in implant packaging and sterilization to individual device sterile packaging. The intended use, implant design and implant size availability are unchanged.

## PERFORMANCE TESTING:

A worst case analysis was conducted to determine the appropriate performance testing of the subject device, including:

- Static and Dynamic Axial Compression per ASTM F2077-18
- Static and Dynamic Shear Compression per ASTM F2077-18
- Static Torsion Test per ASTM F2077-18
- Subsidence per ASTM F2267-04(2018)

## CONCLUSION:

Performance testing of the Titanium Interbody System demonstrated substantial equivalence in performance compared to a legally marketed predicate.