(114 days)
No
The device description and performance studies focus on the mechanical properties and surgical implantation of a hip fracture nailing system, with no mention of AI or ML technology.
Yes
The device is described as a "fixation system" for "fractures of the proximal femur," indicating its purpose is to treat physical injury and promote healing, which fits the definition of a therapeutic device.
No
The device is a cephalomedullary fixation system designed for temporary fixation of stable and unstable fractures of the proximal femur, not for diagnosing medical conditions.
No
The device description clearly states it is a "cephalomedullary fixation system designed to be implanted" and includes physical components like "long and short cephalomedullary nails, lag screws, bone screws, and endcaps". This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the temporary fixation of bone fractures in the proximal femur. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a system of implants (nails, screws, endcaps) made of titanium, designed to be surgically implanted.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support and fixation.
N/A
Intended Use / Indications for Use
The Vertex Hip Fracture Nailing System is intended for temporary fixation of stable and unstable fractures of the proximal femur. The Vertex Nail is indicated for use in adult patients for treatment of:
- Pertrochanteric fractures;
- · Intertrochanteric fractures;
- · High subtrochanteric fractures
- · Combinations of the above fractures, including non-union, malunion and tumor resections.
The Long Nail system is additionally indicated for use in adult patients for treatment of:
- · Pertrochanteric fractures associated with shaft fractures;
- · Pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas;
- · Impending pathological fractures;
- · Long subtrochanteric fractures;
- · Ipsilateral femoral fractures;
- · Proximal or distal non-unions, malunions, revision procedures and tumor resections.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The Vertex Hip Fracture Nailing (HFN) System is a cephalomedullary fixation system designed to be implanted and interlocked proximally and distally using bone screws by means of a provided surgical instrumentation kit. Like many of the currently marketed intramedullary nails, the Vertex HFN offers several different proximal and distal locking options from which the surgeon may choose, depending on the nature of the fracture. The Vertex HFN System includes long and short cephalomedullary nails, lag screws, bone screws, and endcaps all of varying lengths and diameters. All parts of the system are manufactured from Titanium 6AL4VELi.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal femur
Indicated Patient Age Range
adult 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)
- Static and Dynamic Axial Compression testing on the full construct using a test method adapted from ISO 7206-4 (this test method is also substantially similar to that in ASTM F384).
- Cutout Testing using an approach described in the scientific literature (there is no applicable ISO/ASTM/AAMI standard).
- Engineering Rationale per ASTM F1264-16 and ASTM F543-07
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Zimmer Biomet Affixus Hip Fracture Nail (K183162), TriGen InterTAN (K040212)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
OrthoXel's Apex Femoral Nailing System (K181375), Apex Tibial Nailing System (K170972)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
April 4, 2024
Image /page/0/Picture/1 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 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.
OrthoXel DAC % Hollace Rhodes Vice President, Orthopedic Regulatory Affairs Musculoskeletal Clinical Regulatory Advisors LLC 803 7th Street NW 3rd Floor Washington, District of Columbia 20001
Re: K233910
Trade/Device Name: Vertex Hip Fracture Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: February 12, 2024 Received: February 12, 2024
Dear Hollace Rhodes:
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"
1
(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 OS 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.
Digitally signed by Joseph P. Joseph P. Russell -S Russell -s Date: 2024.04.04 09:20:02 -04'00'
for: Farzana Sharmin, PhD Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Enclosure
3
Indications for Use
510(k) Number (if known) K233910
Device Name Vertex Hip Fracture Nailing System
Indications for Use (Describe)
The Vertex Hip Fracture Nailing System is intended for temporary fixation of stable and unstable fractures of the proximal femur. The Vertex Nail is indicated for use in adult patients for treatment of:
- Pertrochanteric fractures;
- · Intertrochanteric fractures;
- · High subtrochanteric fractures
- · Combinations of the above fractures, including non-union, malunion and tumor resections.
The Long Nail system is additionally indicated for use in adult patients for treatment of:
- · Pertrochanteric fractures associated with shaft fractures;
- · Pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas;
- · Impending pathological fractures;
- · Long subtrochanteric fractures;
- · Ipsilateral femoral fractures;
- · Proximal or distal non-unions, malunions, revision procedures and tumor resections.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| [X] Prescription Use (Part 21 CFR 801 Subpart D) | [ ] Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/4/Picture/0 description: The image shows the logo for Orthoxel. The word "ORTHO" is in orange, and the word "XEL" is in blue. A line extends from the "O" in "ORTHO" to the "X" in "XEL".
510(k) Summary
1. Manufacturer
OrthoXel DAC, Cube House, Model Farm Road, Cork, Ireland
2. Primary Correspondent
Mark Moynihan, QA/RA Director. Email: mark.moynihan@orthoxel.com Phone: +353212429700
3. Secondary Correspondent
Contact: Ms. Hollace Saas Rhodes, Vice President, Orthopedic Regulatory Affairs MCRA, LLC 803 7th St NW, Floor 3 Washington, DC 20001 Email: hrhodes@mcra.com Phone: (202)552-5807
- Date Prepared 28 March 2024
5. Device Name and Classification Information
Trade/Proprietary Name: Vertex Hip Fracture Nailing System Common/Usual Name: Hip Fracture Nail Classification Name: Intramedullary Fixation Rod Classification Regulation: 21 CFR 888.3020 Medical Specialty: Orthopedics Product Codes: HSB Device Class: II
6. Predicate Devices
The Vertex Hip Fracture Nailing System is substantially equivalent to the primary predicate, the Zimmer Biomet Affixus Hip Fracture Nail (K183162), and the TriGen InterTAN (K040212) with respect to intended use, technological characteristics, and performance data.
5
Image /page/5/Picture/0 description: The image contains the logo for OrthoXel. The word "ORTHO" is written in orange, and the word "XEL" is written in blue. The "X" in "XEL" is stylized with a line extending from the top left of the "X" to the bottom right of the "O" in "ORTHO".
7. Device Description
The Vertex Hip Fracture Nailing (HFN) System is a cephalomedullary fixation system designed to be implanted and interlocked proximally and distally using bone screws by means of a provided surgical instrumentation kit. Like many of the currently marketed intramedullary nails, the Vertex HFN offers several different proximal and distal locking options from which the surgeon may choose, depending on the nature of the fracture. The Vertex HFN System includes long and short cephalomedullary nails, lag screws, bone screws, and endcaps all of varying lengths and diameters. All parts of the system are manufactured from Titanium 6AL4VELi.
8. Indications for Use
The Vertex Hip Fracture Nailing System is intended for temporary fixation and stable and unstable fractures of the proximal femur. The Vertex Nail is indicated for use in adult patients for treatment of:
- . Pertrochanteric fractures;
- Intertrochanteric fractures;
- . High subtrochanteric fractures
- . Combinations of the above fractures, including non-union, malunion and tumor resections.
The Long Nail system is additionally indicated for use in adult patients for treatment of:
- . Pertrochanteric fractures associated with shaft fractures;
- . Pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas;
- . Impending pathological fractures;
- Long subtrochanteric fractures;
- Ipsilateral femoral fractures;
- . Proximal or distal non-unions, malunions, revision procedures and tumor resections.
9. Technological Characteristics and Substantial Equivalence
The Vertex Hip Fracture Nailing System is substantially equivalent to the predicate device, the Zimmer Biomet Affixus Hip Fracture Nail (K183162), based on the following:
- Intended Use: Both systems are intended for use in the stabilization of fractures in the ● proximal femur.
- . Design: Both systems employ an intramedullary nail, lag screw, optional proximal stabilizing screws, and distal interlocking screws.
- Materials: Both systems are made of titanium alloy.
- Dimensions: The nails, lag screws, and supplemental screws are available in the same range of lengths and diameters as the predicate or other legally marketed devices.
Evaluation of the associated risks do not raise different or new questions of safety or effectiveness. Therefore, based on the intended use, indications for use, technological characteristics, and principles of operation, the Vertex Hip Fracture Nailing System is substantially equivalent to the predicate device.
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Image /page/6/Picture/0 description: The image shows the logo for Orthoxel. The word "ORTHO" is written in orange, block letters. Below that, the word "XEL" is written in blue, block letters, with a line extending from the "O" in "ORTHO" to the "X" in "XEL".
10. Reference Devices
OrthoXel's Apex Femoral Nailing System (K181375) and Apex Tibial Nailing System (K170972) are included as reference devices based on similarities in raw materials, manufacturing steps and reagents, technological characteristics, and performance data.
11. Non-Clinical Performance Testing
All necessary testing has been performed for the worst-case configuration of the Vertex Hip Fracture Nailing System to assure substantial equivalence to its predicates and to demonstrate the subject devices perform as intended. The performance of Vertex Hip Fracture Nailing System was characterized through the following tests:
- . Static and Dynamic Axial Compression testing on the full construct using a test method adapted from ISO 7206-4 (this test method is also substantially similar to that in ASTM F384).
- . Cutout Testing using an approach described in the scientific literature (there is no applicable ISO/ASTM/AAMI standard).
- . Engineering Rationale per ASTM F1264-16 and ASTM F543-07
12. Conclusion
The Vertex Hip Fracture Nailing System possesses the same intended use and technological characteristics as the predicate device. Therefore, the Vertex Hip Fracture Nailing System is substantially equivalent for its intended use.