(88 days)
No.
The device description and performance studies do not mention any AI, DNN, or ML components or functionalities; it describes a mechanical implant and associated tools.
Yes
The device is used to reduce vertebral compression fractures and restore vertebral height, which are direct treatments for a medical condition.
No
The VCFix Spinal System is an implantable device used to reduce vertebral compression fractures and restore vertebral height. Its function is interventional/treatment, not diagnostic.
No
The device is a physical, implantable medical device made of titanium alloy with an expandable plate structure. Its description details mechanical and functional testing, and it is intended to be inserted into the human body using a transpedicular approach. There is no mention of software components or capabilities.
No.
An IVD is a device used to perform tests on samples taken from the human body, such as blood or tissue, to diagnose diseases or conditions. The VCFix Spinal System is an implantable surgical device used for the reduction of vertebral compression fractures within the body, not for in vitro analysis of samples.
N/A
Intended Use / Indications for Use
The VCFix Spinal System is indicated for use in the reduction of vertebral compression fractures that may result from osteoporosis or trauma (fracture types A according to Magerl/AO Spine classification) with or without posterior instrumental fixation, and compression fractures that result from malignant lesions (myeloma or osteolytic metastasis). The VCFix Spinal System is intended to be used in combination with Teknimed F20 bone cement, and to be placed, using a transpedicular approach, in a fractured vertebra from level T9 to L5.
Product codes
NDN
Device Description
The VCFix Spinal System is a cannulated screw-shaped implant with an expandable plate structure and is available in multiple sizes to accommodate varying patient anatomy. A pair of implants are inserted into the pedicles and manipulated with the toolset, resulting in the expansion of the device to restore the vertebral height. The implant is made of titanium alloy (Ti6Al4V ELI). During the procedure, the surgeon inserts the implants bilaterally through each pedicle of the fractured vertebra and adjusts the height and angle of the device (to correct local kyphosis) based on the unique vertebral fracture of the patient.
The VCFix Spinal System includes sterile, single-use implantation kits and a preparation kit. The kits include a pair of implants and all tools necessary for preparing the implant site and vertebral body expansion. The positioning and expansion of the implant must imperatively be followed by the injection of Teknimed F20 bone cement (K103433) to fixate the restored vertebral body. The bone cement and its delivery system are sold separately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Thoracic and lumbar vertebrae, transpedicular approach
Indicated Patient Age Range
Adult
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
Mechanical and functional testing was performed to verify the design of the implant, including:
- Lift Force Testing
- ASTM F2077 Static Compression
- ASTM F2077 Dynamic Compression
- ASTM F2077 Static Shear
- ASTM F2077 Dynamic Shear
- ASTM F2193 Static Torsion Test
- ASTM F2193 Screw Driving Torque
- Functionality Tests of VCFix Implant with Cement
- Magnetic Resonance Safety Testing to support MR Conditional Labeling
- Biological safety evaluation per ISO 10093-1
- Validation activities to support additive manufacturing processes
- Packaging, sterility, and shelf-life validation activities
The different technological characteristics were found to raise no new questions of safety or effectiveness. All necessary testing has been performed for the worst-case configuration of the VCFix Spinal System to assure substantial equivalence to its predicates and to demonstrate the subject devices perform as intended.
Key Metrics
Not Found
Predicate Device(s)
Stryker SpineJack System (K223294)
Reference Device(s)
Injection Pin (K221697), Teknimed F20 bone cement (K103433)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
FDA 510(k) Clearance Letter - VCFix Spinal System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 30, 2025
Amber Implants
Banafsheh Sajadi
Chief Executive Officer
Prinses Beatrixlaan 546
The Hague, 2595 BM
Netherlands
Re: K250637
Trade/Device Name: VCFix Spinal System
Regulation Number: 21 CFR 888.3027
Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement
Regulatory Class: Class II
Product Code: NDN
Dated: February 14, 2025
Received: March 3, 2025
Dear Banafsheh Sajadi:
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.
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K250637 - Banafsheh Sajadi 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-
Page 3
K250637 - Banafsheh Sajadi 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,
JESSE MUIR -S (Digitally signed by JESSE MUIR -S Date: 2025.05.30 14:18:04 -04'00')
Jesse Muir, Ph.D.
Assistant Director
DHT6C: Division of Restorative, Repair and Trauma Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K250637
Device Name
VCFix Spinal System
Indications for Use (Describe)
The VCFix Spinal System is indicated for use in the reduction of vertebral compression fractures that may result from osteoporosis or trauma (fracture types A according to Magerl/AO Spine classification) with or without posterior instrumental fixation, and compression fractures that result from malignant lesions (myeloma or osteolytic metastasis). The VCFix Spinal System is intended to be used in combination with Teknimed F20 bone cement, and to be placed, using a transpedicular approach, in a fractured vertebra from level T9 to L5.
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.
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Page 5
510(k) Summary
Device Trade Name: VCFix Spinal System
Common Name: Implantable Fracture Reduction System
Manufacturer: Amber Implants
Prinses Beatrixlaan 546,
2595 BM The Hague,
The Netherlands
Contact: Banafsheh Sajadi
Chief Executive Officer
Phone: +31 6 11 27 37 31
Email: b.sajadi@amberimplants.com
Prepared by: Justin Eggleton
MCRA, LLC
803 7th Street, NW
Washington, DC 20001
Office: 202.552.5800
Email: jeggleton@mcra.com
Date Prepared: May 30, 2025
Classifications: 21 CFR §888.3027, Polymethylmethacrylate (PMMA) bone cement
Class: II
Product Codes: NDN, Cement, Bone, Vertebroplasty
Indications For Use:
The VCFix Spinal System is indicated for use in the reduction of vertebral compression fractures that may result from osteoporosis or trauma (fracture types A according to Magerl/AO Spine classification) with or without posterior instrumental fixation, and compression fractures that result from malignant lesions (myeloma or osteolytic metastasis). The VCFix Spinal System is intended to be used in combination with Teknimed F20 bone cement, and to be placed, using a transpedicular approach, in a fractured vertebra from level T9 to L5.
Device Description:
The VCFix Spinal System is a cannulated screw-shaped implant with an expandable plate structure and is available in multiple sizes to accommodate varying patient anatomy. A pair of implants are inserted into the pedicles and manipulated with the toolset, resulting in the expansion of the device
Page 6
to restore the vertebral height. The implant is made of titanium alloy (Ti6Al4V ELI). During the procedure, the surgeon inserts the implants bilaterally through each pedicle of the fractured vertebra and adjusts the height and angle of the device (to correct local kyphosis) based on the unique vertebral fracture of the patient.
The VCFix Spinal System includes sterile, single-use implantation kits and a preparation kit. The kits include a pair of implants and all tools necessary for preparing the implant site and vertebral body expansion. The positioning and expansion of the implant must imperatively be followed by the injection of Teknimed F20 bone cement (K103433) to fixate the restored vertebral body. The bone cement and its delivery system are sold separately.
Predicate Devices:
Amber Implants submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, VCFix Spinal System is substantially equivalent in indications, design principles, and performance to the following legally marketed predicate devices:
Primary Predicate: Stryker SpineJack System (K223294)
Reference Devices: Injection Pin (K221697) by SLK Ortho LLC
Teknimed F20 bone cement (K103433)
Summary of Technological Characteristics:
The subject and predicate devices have the same intended use with similar technological characteristics:
- Intended Use: Intended for the adult population to treat fractures in the thoracolumbar vertebrae caused by osteoporosis, trauma, and tumors, with or without posterior instrumental fixation.
- Principle of Operation: Devices are placed with a minimally invasive, bilateral transpedicular approach, and are inserted through the pedicles into the site in a collapsed form, expanded in the cranio-caudal direction (subject and primary predicate), and then FDA-cleared bone cement is injected through and around the implant to maintain the fracture reduction. Supplemental posterior fixation is placed if necessary.
- Material: Manufactured from titanium alloy.
- Design: Cannulated devices which are offered in a variety of implant sizes to accommodate varying patient anatomy. There are minor differences in the overall geometry of the device, however, the major dimensions fall within the range of previously cleared sizes for the intended use. Compared to the primary predicate, different features of the subject device (e.g., perforated expansion plates, length, diameter) are supported by the reference device and performance testing.
- Sterility: Sterile, for single use only.
Detailed information is provided in the table below.
Page 7
| Characteristics | Subject Device VCFix Spinal System | Primary Predicate Device Stryker SpineJack System (K223294) | Reference Device SLK Ortho LLC, Injection Pin (K221697) | Comparison |
|---|---|---|---|---|
| Classification | Class II | Class II | Class II | Identical |
| Regulation | 21 CFR 888.3027 | 21 CFR 888.3027 | 21 CFR 888.3027 | Identical |
| Product Code | NDN | NDN | NDN, LOD | Identical |
| Panel | Orthopedic | Orthopedic | Orthopedic | Identical |
| Intended Use | Intended for the reduction of vertebral compression fractures | Intended for the reduction of vertebral compression fractures | Intended for the reduction of vertebral compression fractures | Identical |
| Indications for Use | The VCFix Spinal System is indicated for use in the reduction of vertebral compression fractures that may result from osteoporosis or trauma (fracture types A according to Magerl/AO Spine classification) with or without posterior instrumental fixation, and compression fractures that result from malignant lesions (myeloma or osteolytic metastasis). The VCFix Spinal System is intended to be used in combination with Teknimed F20 bone cement, and to be placed, using a transpedicular approach, in a fractured vertebra from level T9 to L5. | The SpineJack Expansion Kit is indicated for use in the reduction of painful osteoporotic vertebral compression fractures, traumatic vertebral compression fractures (Type A fractures according to the AO/Magerl classification) with or without posterior instrumental fixation, and compression fractures that result from malignant lesions (myeloma or osteolytic metastasis). It is intended to be used in combination with Stryker Vertaplex and Vertaplex HV bone cement. | Indicated for use in fractures caused by severe osteoporosis, trauma, and tumors of the thoracic/lumbar spine from T9-L5. Injection Pin is indicated for use in combination with PMMA bone cement (Teknimed F20) for the treatment of fractures caused by trauma, osteoporosis, or tumors in the thoracic/lumbar spine from T9-L5. | Same as primary predicate; specified level T9 to L5. Modified the compatible bone cement trade name which is the same as the reference devices: Teknimed F20 bone cement (K103433). |
| Target Population | Adult | Adult | Adult | Identical |
| Anatomical Site | Thoracic and lumbar vertebrae, transpedicular approach | Thoracic and lumbar vertebrae, transpedicular approach | Thoracic and lumbar vertebrae | Identical |
| Contact | Implant: implant device - permanent contact (> 30 days) with bone/tissue Toolset: external communicating device - limited contact ( 30 days) with bone/tissue Toolset: external communicating device - limited contact ( 30 days) with bone/tissue | Identical | ||
| System Components | VCFix Spinal System consists of: • VCFix Preparation kit (to prepare the access to the vertebral body) • VCFix Implantation kit (implant and implant inserter/expander) | SpineJack System consists of: • SpineJack Preparation kit (to prepare the access to the vertebral body) • SpineJack Expansion kit (implant and implant inserter/expander) | The Injection Pin system consists of: • Injection Pin implant • Injection Pin Screwdriver | Same |
| Presentation of the Device | Sterile, single use devices | Sterile, single use devices | Sterile, single use devices | Identical |
Page 8
| Characteristics | Subject Device VCFix Spinal System | Primary Predicate Device Stryker SpineJack System (K223294) | Reference Device SLK Ortho LLC, Injection Pin (K221697) | Comparison |
|---|---|---|---|---|
| Materials | • Implant: Ti-6Al-4V (ASTM F3001, ASTM F136) • Toolset: stainless steel shafts + plastic handles (except for inner dilator made of PPSU) | • Implant: Ti-6Al-4V (ISO 5832-3) • Toolset: stainless steel shafts + plastic handles | • Implant: Ti-6Al-4V (ISO 5832-3, ASTM F136) | Same-Implant Similar-Instruments |
| Implant Sizes | 7 sizes: Major dimensions: • Insertion Diameter: o 5mm – 6.5mm • Total Length in VB: o 41mm – 51.2mm • Expanding Plate Length: o 14.4mm – 21mm • Max Expansion Height: o 11.3mm – 16mm | 3 sizes: Major dimensions: • Insertion Diameter (A): o 4.2mm, 5mm, and 5.8mm • Total Length (B) in VB: o 20mm, 25mm, 28mm • Expanding Plate Length (B): o 14mm, 19mm, 20mm • Max Expansion Height (C): o 12.5mm, 17mm, 20mm | Multiple sizes: • Pin Diameters: o 5 and 6mm • Total Length: o 31 to 61mm (3mm increments) | Similar and within range of predicates. |
| Insertion Feature | Spherical head with internal hexagon for mating with inserter | Mates with implant inserter | Spherical head with internal hexagon for insertion screwdriver | Same |
| Cement Features | Cannulated with perforated structure on the expansion plates | Cannulated with cut-through features | Cannulated and fenestrated screw | Same – all devices are cannulated and allow for cement injection through the length of the device. |
| Expansion Mechanism | The implant expands in the cranio-caudal direction using a jack mechanism. | The implant expands in the cranio-caudal direction using a jack mechanism. | The implant does not expand. | Similar, both the subject and primary predicate implants gradually extend in the craniocaudal direction by use of an implant extender instrument to expand. |
| Anchorage Mechanism | Bone cement and supplemental posterior fixation. Pedicle anchorage to share axial loading between anterior and posterior columns. | Bone cement and supplemental posterior fixation | Bone cement and pedicle anchorage to share axial loading between anterior and posterior columns with bone cement. | Identical |
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| Characteristics | Subject Device VCFix Spinal System | Primary Predicate Device Stryker SpineJack System (K223294) | Reference Device SLK Ortho LLC, Injection Pin (K221697) | Comparison |
|---|---|---|---|---|
| Principle of Operation | VCFix is implanted into the vertebra after access is established and the site is prepared for implants insertion. Vertebral body access is achieved through bilateral transpedicular positioning of the trocar, followed by guidewire, soft tissue dilation, drill, and template to clean the implant's site. The implant is then inserted into the vertebra via the pedicle in a collapsed form, and expanded in situ, to achieve reduction of vertebral compression fractures. Once inserted and expanded, PMMA bone cement is injected into the space within and around VCFix to maintain the fracture reduction. Supplemental posterior fixation is placed if necessary. | The SpineJack is implanted into the vertebra after access is established and the site is prepared for implants insertion. Vertebral body access is achieved through bilateral transpedicular positioning of the trocar, followed by guidewire, drill with working cannula to dilate soft tissue, and template to clean the implant's site. The implant is then inserted into the vertebra via the pedicle in a collapsed form, and expanded in situ, to achieve reduction of vertebral compression fractures. Once inserted and expanded, PMMA bone cement is injected into the space within and around the SpineJack to maintain the fracture reduction. Supplemental posterior fixation is placed if necessary. | The Injection Pin is a cannulated fenestrated screw implanted in the spine through a minimally invasive approach. The device allows for injection of PMMA (Teknimed F20) bone cement. | Identical |
| Surgical Technique Overview | 1. VB access and guidewire insertion 2. Dilate soft tissue 3. Drill advanced into VB 4. Template to verify implant length 5. Insert unexpanded VCFix implants into VB 6. VCFix implants expanded 7. Cement injection 8. Supplemental posterior fixation placed (if needed) | 1. VB access and guidewire insertion 2. Dilate soft tissue 3. Reamer advanced into VB 4. Template to verify implant length 5. Insert unexpanded SpineJack implants into VB 6. SpineJack implants expanded 7. Cement injection 8. Supplemental posterior fixation placed (if needed) | Implant inserted with injection pin screwdriver followed by cement injection. | Identical to primary predicate |
| Instruments | Provided in sterile kit: Preparation Kit: • K-wire • Two-part dilator • Drill • Template Implantation Kit: • VCFix Implant • Implant Inserter • Implant Expander | Provided in sterile kit: Preparation Kit: • Guidewire • Access cannula • Working cannula • Reamer • Template Expansion Kit: • Implant expander tube | Injection pin screwdriver Compatible with previously cleared Teknimed F20 cement injection tools. | Same |
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| Characteristics | Subject Device VCFix Spinal System | Primary Predicate Device Stryker SpineJack System (K223294) | Reference Device SLK Ortho LLC, Injection Pin (K221697) | Comparison |
|---|---|---|---|---|
| Compatible with previously cleared Teknimed F20 cement injection tools. | • Handles • SpineJack Implants • Quick release pin Cement Injection Tools | |||
| Performance Testing | Mechanical and functional testing was performed to verify the design of the implant, including: • Lift Force Testing • ASTM F2077 Static Compression • ASTM F2077 Dynamic Compression • ASTM F2077 Static Shear • ASTM F2077 Dynamic Shear • ASTM F2193 Static Torsion Test • ASTM F2193 Screw Driving Torque • Functionality Tests of VCFix Implant with Cement | Mechanical and functional testing was performed to verify the design of the implant, including: • Pushing and Recompression Testing (i.e., Lift Force Testing) • Crimp Force Testing • Traction Resistance Testing • Torsion Testing • Functional Tests of SpineJack Implant with Cement | Unknown | Same – systems demonstrate sufficient strength for the intended use. |
The different technological characteristics were found to raise no new questions of safety or effectiveness.
Performance Testing Summary:
All necessary testing has been performed for the worst-case configuration of the VCFix Spinal System to assure substantial equivalence to its predicates and to demonstrate the subject devices perform as intended.
The performance of the VCFix Spinal System in its final, finished configuration are supported by the following:
- Lift Force Testing
- ASTM F2077 Static Compression Testing
- ASTM F2077 Dynamic Compression
- ASTM F2077 Static Shear
- ASTM F2077 Dynamic Shear
- ASTM F2193 Static Torsion and Driving Torque Testing
- Functionality Testing
- Magnetic Resonance Safety Testing to support MR Conditional Labeling
- Biological safety evaluation per ISO 10093-1
- Validation activities to support additive manufacturing processes
- Packaging, sterility, and shelf-life validation activities
Page 11
Substantial Equivalence Conclusion:
The subject device and the predicate devices have the same intended use/indications for use, sufficiently similar performance, fundamental scientific technology and principles of operation. The data included in this submission demonstrate there are no new risks raised by the subject system and supportive of substantial equivalence. VCFix Spinal System is as safe, as effective, and performs as well as, or better, than the predicate devices.