← Product Code [OUR](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OUR) · K250247 # panaSIa SI Fusion System (K250247) _Wenzel Spine, Inc. · OUR · Jul 9, 2025 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OUR/K250247 ## Device Facts - **Applicant:** Wenzel Spine, Inc. - **Product Code:** [OUR](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OUR.md) - **Decision Date:** Jul 9, 2025 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The panaSIa SI Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. ## Device Story The panaSIa SI Fusion System is a threaded, expandable implant designed to stabilize the sacroiliac joint. The device is inserted into the joint space and expanded to pierce adjacent cortical bone, providing mechanical fixation. It features large fenestrations to facilitate bone graft contact across the joint space. The device is intended for long-term implantation and is provided sterile for single-patient use. It is used by surgeons in a clinical/surgical setting to treat joint instability and degeneration. The implant's design and expansion mechanism aim to promote fusion by stabilizing the joint and allowing for bone ingrowth through the fenestrations, ultimately reducing patient pain and improving joint function. ## Clinical Evidence No clinical data provided. Evidence consists of non-clinical bench testing, including static and dynamic vertical shear testing per ASTM F3574, and cadaveric testing comparing the subject device to the additional predicate. ## Technological Characteristics Threaded, expandable implant; titanium grade alloy construction; large fenestrations for graft contact; sterile, single-patient use; long-term implantable. Mechanical fixation via cortical bone piercing upon expansion. Testing performed per ASTM F3574. ## Regulatory 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 - Camber Spine Technologies Camber Sacroiliac (SI) Fixation System ([K233972](/device/K233972.md)) - Medtronic Sofamor RIALTO™ SI Fusion System ([K161210](/device/K161210.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION July 9, 2025 Wenzel Spine, Inc. % Justin Eggleton Vice President, Head of Musculoskeletal Regulatory Affairs MCRA, LLC 803 7th Street NW, Third Floor Washington, District of Columbia 20001 Re: K250247 Trade/Device Name: panaSIa SI 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: January 27, 2025 Received: June 16, 2025 Dear Justin Eggleton: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K250247 - Justin Eggleton Page 2 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). 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- {2} K250247 - Justin Eggleton Page 3 assistance/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, MAZIAR SHAH-MOHAMMADI -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 {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) K250247 Device Name panaSla SI Fusion System Indications for Use (Describe) The panaSla SI Fusion System is intended for sacroiliac 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *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: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov > "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4} K250247- Page 1 of 2 510(k) Summary Device Trade Name: panaSIa SI Fusion System Manufacturer: Wenzel Spine, Inc. 2535 Brockton Drive, Suite 450 Austin, TX 78758 Contact: Justin Eggleton Vice President, Head of Musculoskeletal Regulatory Affairs MCRA, LLC 803 7th Street, NW Washington, DC 20001 jeggleton@mcra.com Prepared by: MCRA, LLC 803 7th Street, NW, 3rd Floor Washington, DC 20001 Office: 202.552.5800 Date Prepared: July 8, 2025 Classifications: 21 CFR §888.3040 Class: II Product Code: OUR Primary Predicate: Camber Spine Technologies Camber Sacroiliac (SI) Fixation System (K233972) Additional Predicate: Medtronic Sofamor RIALTO™ SI Fusion System (K161210) Indications For Use: The panaSIa SI Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. Device Description: The panaSIa SI Fusion device is a threaded, expandable device, designed to stabilize the sacroiliac joint by piercing the adjacent cortical bone when expanded. The device has large fenestrations to allow for uninterrupted graft contact across the SI joint space. The panaSIa SI Fusion implant is a sterile, single patient use, long-term implantable device made of a titanium grade alloy. {5} K250247- Page 2 of 2 ## Performance Testing Summary: To support the clearance of the subject device, Wenzel Spine completed non-clinical testing. The non-clinical testing data submitted and relied upon to demonstrate substantial equivalence included static and dynamic vertical shear testing per ASTM F3574 and cadaver testing with comparison to the additional predicate device. ## Substantial Equivalence: The subject device was demonstrated to be substantially equivalent to the predicate devices with respect to intended use, principles of operation, indications for use, design, materials, and performance. The subject device and the predicate devices are intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. The subject device and the predicate devices have similar principles of operation, designs, performance, and use similar materials. ## Conclusion: The subject device and the predicate devices have the same intended use, have similar technological characteristics, principles of operation, performance, and are made of similar materials. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above. The panaSIa SI Fusion System is as safe, as effective, and performs as well as, or better, than the predicate devices. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OUR/K250247](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/OUR/K250247) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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