(261 days)
No
The device description and intended use focus on a mechanical intramedullary nailing system for fracture fixation. There is no mention of AI, ML, image processing, or any software-based analysis or decision-making components.
No.
This device is for temporary fixation of fractures, not for providing therapy.
No
The device is described as an "intramedullary fixation system" intended for "temporary fixation of the fractures of the tibia," which acts as an implant for treatment rather than for diagnosis.
No
The device description clearly states that the Apex Tibial Nailing System includes a tibial nail, bone screws, and endcaps, all of which are physical hardware components made from Titanium. It also mentions a reusable surgical instrumentation kit. This is a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "temporary fixation of the fractures of the tibia" and lists various types of bone fractures and conditions. This is a therapeutic and structural purpose, not a diagnostic one.
- Device Description: The description details a system of implants (nail, screws, endcaps) made of titanium, designed for surgical implantation to stabilize bone fractures. This is consistent with a surgical implant, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, tissue, etc.) from the human body to provide information about a physiological state, health, disease, or congenital abnormality.
In summary, the Apex Tibial Nailing System is a surgical implant used for the treatment of bone fractures, which falls under the category of medical devices, but not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Apex Tibial Nailing system is intended for temporary fixation of the fractures of the tibia. The Apex nail is indicated for used in adult patients for treatment of:
- · Open and closed tibial fractures, including simple, severely comminuted, spiral, large oblique, and segmental fractures;
- · Fractures involving osteopenic or osteoporotic bone;
- · Fractures with bone loss;
- Pseudoarthosis, nonunion, and malunion;
- · Correction osteotomy;
- · Pathologic fractures and prophylactic nailing of impending pathologic fractures; and
- · Reconstruction following tumour resection.
Product codes
HSB, HWC
Device Description
The Apex Tibial Nailing System is a tibial intramedullary fixation system designed to be implanted and interlocked proximally and distally using bone screws by means of a provided reusable surgical instrumentation kit. Like many of the currently-marketed intramedullary nails, the Apex Nail offers several different proximal and distal locking options from which the surgeon may choose, depending on the fracture. An insert within the proximal nail stem maintains the torsional stability of static locking when the construct is locked in a dynamization mode. The Apex Tibial Nailing System includes a tibial nail, bone screws and endcaps of varying sizes. All parts of the system are manufactured from Titanium 6AL4VELi. The Apex Tibial Nail, screw and endcap are available in varying lengths and diameters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tibia
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)
The Apex Tibial Nailing System was tested in accordance with the following standards and all acceptance criteria were met:
- . ASTM F1264-16 - Standard specification and test methods for intramedullary fixation devices.
- ASTM F543-07 – Standard specification and test methods for metallic medical bone screws.
- Full construct fatigue testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 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 the FDA logo, which 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.
December 20, 2017 OrthoXel % Hollace Rhodes Director, Orthopedic Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers LLC 1050 K Street NW Suite 1000 Washington, District of Columbia 20001
Re: K170972
Trade/Device Name: Apex Tibial Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB, HWC Dated: November 20, 2017 Received: November 20, 2017
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 (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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Vincent J. Devlin -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Apex Tibial Nailing System
The Apex Tibial Nailing system is intended for temporary fixation of the fractures of the tibia. The Apex nail is indicated for used in adult patients for treatment of:
- · Open and closed tibial fractures, including simple, severely comminuted, spiral, large oblique, and segmental fractures;
- · Fractures involving osteopenic or osteoporotic bone;
- · Fractures with bone loss;
- Pseudoarthosis, nonunion, and malunion;
- · Correction osteotomy;
- · Pathologic fractures and prophylactic nailing of impending pathologic fractures; and
- · Reconstruction following tumour resection.
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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510(k) Summary for Apex Tibial Nailing System
1.1 Submission Sponsor
OrthoXel, Rubicon Centre, Bishopstown, Cork, Ireland, T12 Y275 Phone: +353 21 2429700
Contact: Aisling O'Sullivan QA/RA Manager Email: aisling.osullivan@orthoxel.ie
- 1.2 Prepared by
Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street, NW, Suite 1000 Washington, DC 20001 Phone: 202.552.5800
Contact: Ms. Hollace Saas Rhodes Director, Orthopedic Regulatory Affairs Email: hrhodes@mcra.com
- 1.3 Date Prepared
18 December 2017
1.4 Device Name
| 1.4.1 | Trade/Proprietary Name: | Apex Tibial Nailing System |
|---|---|---|
| 1.4.2 | Common/Usual Name: | Tibial Nail |
| 1.4.3 | Classification Name: | Intramedullary Fixation Rod |
| 1.4.4 | Classification Regulation: | 21 CFR 888.3020 |
| 1.4.5 | Classification Panel: | Orthopedics |
| 1.4.6 | Product Codes: | HSB, HWC |
| 1.4.7 | = |
1.5 Predicate Devices
The System is substantially equivalent to the Biomet Tibial Locking Nail System (K063570), the Zimmer Natural Nail (K082770), and L.T.S. IM Nail Systems CFN-CHN (K132945) based on similarities in intended use, technological characteristics, and performance data.
4
1.6 Device Description
The Apex Tibial Nailing System is a tibial intramedullary fixation system designed to be implanted and interlocked proximally and distally using bone screws by means of a provided reusable surgical instrumentation kit. Like many of the currently-marketed intramedullary nails, the Apex Nail offers several different proximal and distal locking options from which the surgeon may choose, depending on the fracture. An insert within the proximal nail stem maintains the torsional stability of static locking when the construct is locked in a dynamization mode. The Apex Tibial Nailing System includes a tibial nail, bone screws and endcaps of varying sizes. All parts of the system are manufactured from Titanium 6AL4VELi. The Apex Tibial Nail, screw and endcap are available in varying lengths and diameters.
1.7 Intended Use
The Apex Tibial Nailing System is intended for temporary fixation of the fractures of the tibia. The Apex nail is indicated for used in adult patients for treatment of:
- . Open and closed tibial fractures, including simple, severely comminuted, spiral, large oblique, and segmental fractures;
- . Fractures involving osteopenic or osteoporotic bone;
- Fractures with bone loss;
- Pseudoarthrosis, nonunion, and malunion;
- Correction osteotomy;
- Pathologic fractures and prophylactic nailing of impending pathologic fractures; and
- Reconstruction following tumour resection.
1.8 Technological Characteristics and Substantial Equivalence
The Apex Tibial Nailing System is substantially equivalent to the Biomet Tibial Locking Nail System, the Zimmer Natural Nail, and the L.T.S. IM Nail Systems CFN-CTN-CHN with respect to intended use, technological characteristics (components, materials, overall design, and dimensions), sterility, and principles of operation.
1.9 Non-Clinical Performance Testing
The Apex Tibial Nailing System was tested in accordance with the following standards and all acceptance criteria were met:
- . ASTM F1264-16 - Standard specification and test methods for intramedullary fixation devices.
- ASTM F543-07 – Standard specification and test methods for metallic medical bone screws.
- Full construct fatigue testing
Conclusion 1.10
This 510(k) submission supports the substantial equivalence of the Apex Tibial Nailing System to the referenced predicate devices.