CATAMARAN SI Joint Fusion System

K231944 · Tenon Medical, Inc. · OUR · Aug 24, 2023 · Orthopedic

Device Facts

• Record ID: K231944
• Device Name: CATAMARAN SI Joint Fusion System
• Applicant: Tenon Medical, Inc.
• Product Code: OUR · Orthopedic
• Decision Date: Aug 24, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Tenon Medical CATAMARAN SI Joint Fusion System is intended for sacroillac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Device Story

The CATAMARAN SI Joint Fusion System is a surgical implant system used for sacroiliac joint fusion. It serves as a less invasive alternative to traditional open posterior surgical fusion. The system includes Ti6Al-4V ELI titanium alloy implants and a set of reusable surgical instruments (access, drill, delivery, bone graft packing, and extraction tools). During surgery, the physician uses an inferior-posterior approach to place the implant into the sacroiliac joint. The implant barrels are designed to hold autologous bone graft material to facilitate fusion. The device is provided non-sterile and requires steam sterilization before use. The system is intended for use in a clinical surgical setting by a physician.

Clinical Evidence

Bench testing only. MR compatibility assessments were conducted in accordance with FDA guidance, including testing for magnetically induced displacement force (ASTM F2052-21), image artifacts (ASTM F2119-13), RF-induced heating (ASTM F2182-19e2), and magnetically induced torque (ASTM F2213-17).

Technological Characteristics

Implant material: Ti6Al-4V ELI Titanium alloy (ASTM F136). System includes reusable surgical instruments and system tray. Implants are provided non-sterile; sterilization via steam. MR Conditional status supported by ASTM F2052-21, F2119-13, F2182-19e2, F2213-17, and F2503-20.

Indications for Use

Indicated for sacroiliac joint fusion in patients with sacroiliac joint disruptions and degenerative sacroiliitis.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• CATAMARAN™ Sacroiliac Joint Fixation System (K180818)

Submission Summary (Full Text)

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August 24, 2023

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Tenon Medical, Inc. % Susan Noriega Regulatory Affairs, Clinical and Quality Consultant Lince Consulting, LLC 111 Deerwood Road, Suite 200 San Ramon, California 94583

## Re: K231944

Trade/Device Name: CATAMARAN™ SI Joint Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR Dated: June 30, 2023 Received: June 30, 2023

## Dear Susan Noriega:

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

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Eileen
Digitally signed by
Eileen Cadel -S
Date: 2023.08.24
Cadel -S 13:14:07-04'00'

for

Colin O'Neill, M.B.E. 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) K231944

Device Name CATAMARAN™ SI Joint Fusion System

Indications for Use (Describe)

The Tenon Medical CATAMARAN SI Joint Fusion System is intended for sacroillac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

| 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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### 510(k) SUMMARY CATAMARAN™ SI Joint Fusion System

#### l. DATE PREPARED

June 30, 2023

#### 510(k) SUBMITTER II.

Tenon Medical, Inc. 104 Cooper Court Los Gatos, CA 95032 Phone: [phone]

Contact Person: Susan Noriega, Regulatory, Clinical and Quality Consultant Lince Consulting, LLC 111 Deerwood Road, Suite 200 San Samon, CA 94583 e-mail: [e-mail] Mobile: [phone]

FDA Establishment Registration No.: 3015425107

#### lll. DEVICE

| Trade Name of Device: | CATAMARAN™ SI Joint Fusion System |
|-----------------------|------------------------------------------------------------|
| Common or Usual Name: | Sacroiliac Joint Fixation |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3040; Smooth or threaded metallic bone fastener |
| Product Code: | OUR |

#### IV. PREDICATE DEVICE

| Primary Predicate Device | Manufacturer | Product<br>Code | 510(k)# | Clearance Date |
|------------------------------------------------|---------------|-----------------|---------|----------------|
| CATAMARAN™ Sacroiliac Joint<br>Fixation System | Tenon Medical | OUR | K180818 | June 13, 2018 |

#### V. INDICATIONS FOR USE

The Tenon Medical CATAMARAN™ SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.

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#### VI. DEVICE DESCRIPTION

The CATAMARAN SI Joint Fusion System is intended for sacroillac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis. The CATAMARAN SI Joint Fusion System was developed as a less invasive alternative to traditional open posterior surgical SI Joint fusion. The system consists of the CATAMARAN SI Joint Fixation Implant (Ti6A1-4V ELI Titanium alloy / ASTM F136) included in a reusable System Tray containing: Access, Drill and Delivery, Bone Graft Packing, and Extraction Instruments. The CATAMARAN SI Joint Fixation Implants are designed in various widths and lengths, and allow autologous bone graft material placement in the barrels of the implant to support SI Joint fixation and fusion. The Instrument Set includes Class II single use and reusable surgical instruments designed to facilitate placement of the implant within the sacroillac joint using an inferiorposterior surgical approach. The implants and associated instruments are provided clean and non-sterile and are designed for steam sterilization prior to use.

#### SUMMARY OF VERIFICATION AND VALIDATION ACTIVITIES VII.

The subject 510(k) Submission requests MR Conditional Labeling for the CATAMARAN SI Joint Fusion Implant to support use in an MR Environment. MR Compatibility Assessments were performed using FDA Guidance: Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (May 20, 2021) and Assessment of Radiofrequency Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices (March 22, 2016). The results of the MR Compatibility testing support the use of the CATAMARAN SI Joint Fusion Implant in an MR Environment as MR Conditional.

### Design Verification Standards Testing

| MR<br>Compatibility<br>Assessment | • ASTM F2052-21 - Standard Test Method for Measurement of Magnetically<br>Induced Displacement Force on Medical Devices in the Magnetic Resonance<br>Environment |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | • ASTM F2119-13 (17) - Standard Test Method for Evaluation of MR Image<br>Artifacts from Passive Implants |
| | • ASTM F2182-19e2 - Standard Test Method for Measurement of Radio<br>Frequency Induced Heating on or Near Passive Implants During Magnetic<br>Resonance Imaging |
| | • ASTM F2213-17 - Standard Test Method for Measurement of Magnetically<br>Induced Torque on Medical Devices in the Magnetic Resonance Environment |
| | • ASTM F2503 -20 - Standard Practice for Marking Medical Devices and Other<br>Items for Safety in the Magnetic Resonance Environment |

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### VIII. SUMMARY OF SUBSTANTIAL EQUIVALENCE

The CATAMARAN SI Joint Fusion System has the same intended use, indications for use, technological characteristics (with minor changes to the instruments and system tray), and principles of operation as compared to the predicate device; the CATAMARAN Sacroiliac Joint Fixation System cleared in K180818.

Any minor differences between the CATAMARAN SI Joint Fusion System and the predicate device do not raise any new types of safety or effectiveness questions, including the MR Compatibility Assessment. Testing demonstrates that the CATAMARAN SI Joint Fusion System meets requirements for its intended clinical use.

#### IX. CONCLUSION

Based on the similarities in intended use, indications for use and technological characteristics, the subject CATAMARAN SI Joint Fusion System is substantially equivalent to the predicate device.