(153 days)
Not Found
No
The device description and performance studies focus on mechanical properties and surgical instrumentation, with no mention of AI or ML.
Yes
This device is a therapeutic device because its intended use is to facilitate tibiotalocalcaneal arthrodesis (fusion) for various medical conditions, directly treating and resolving patient ailments.
No
This device is a surgical implant (nailing system) used for tibiotalocalcaneal arthrodesis (fusion), not for diagnosing medical conditions.
No
The device description explicitly states that the system comprises implantable intramedullary nails, locking end caps, locking screws, and instrumentation, all of which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Orthofix Ankle Hindfoot Nailing System is an implantable device made of titanium alloy. It is surgically placed within the body to facilitate bone fusion.
- Intended Use: The intended use is to facilitate tibiotalocalcaneal arthrodesis (fusion), which is a surgical procedure.
The device is a surgical implant, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The Orthofix Ankle Hindfoot Nailing System is intended to facilitate tibiotalocalcaneal arthrodesis (fusion). Specific indications include:
- Avascular necrosis of the talus
- Failed total ankle arthroplasty
- Trauma (malunited tibial pilon fracture)
- Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
- Revision ankle arthrodesis
- Neuroarthropathy
- Rheumatoid arthritis
- Osteoarthritis
- Pseudoarthrosis
- Post-traumatic arthrosis
- Previously infected arthrosis
- Charcot foot
- Severe endstage degenerative arthritis
- Severe defects after tumor resection
- Pantalar arthrodesis
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The Orthofix Ankle Hindfoot Nailing System comprises a variety of implantable intramedullary nails with respective locking end caps and locking screws manufactured from titanium alloy (Ti6Al4V) which are intended to facilitate tibiotalocalcaneal arthrodesis (fusion). The system also includes instrumentation required for implantation and explantation of the implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ankle, Hindfoot, Tibiotalocalcaneal
Indicated Patient Age Range
Not Found
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)
Mechanical testing of the Orthofix Ankle Hindfoot Nailing System consisting of Static Four-Point Bend testing, Static Torsion testing, and Bending Fatigue testing was conducted in accordance with ASTM F1264-03 “Standard Specification and Test Methods for Intramedullary Fixation Devices.” Test results demonstrate that the Orthofix Ankle Hindfoot Nailing System is substantially equivalent to the predicate device.
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.
Biomet Phoenix Ankle Arthrodesis Nail System – K091976
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.
Not Found
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 12, 2014
Orthofix Srl % Mr. Troy Brooks Senior Regulatory Affairs Specialist 3451 Plano Parkway Lewisville, Texas 75056
Re: K141571
Trade/Device Name: Orthofix Ankle Hindfoot Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: October 10, 2014 Received: October 14, 2014
Dear Mr. Brooks,
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, Lori A. Wiggins -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K141571
Device Name Orthofix Ankle Hindfoot Nailing System
Indications for Use (Describe)
The Orthofix Ankle Hindfoot Nailing System is intended to facilitate tibiotalocalcaneal arthrodesis (fusion). Specific indications include:
-
- Avascular necrosis of the talus
-
- Failed total ankle arthroplasty
-
- Trauma (malunited tibial pilon fracture)
-
- Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis
- or other neuromuscular disease
-
- Revision ankle arthrodesis
-
- Neuroarthropathy
-
- Rheumatoid arthritis
-
- Osteoarthritis
-
- Pseudoarthrosis
-
- Post-traumatic arthrosis
-
- Previously infected arthrosis
-
- Charcot foot
-
- Severe endstage degenerative arthritis
-
- Severe defects after tumor resection
-
- Pantalar arthrodesis
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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5.0 510(k) Summary
| Date Prepared: | October 10, 2014 |
|---|---|
| Purpose for Submission: | New product offering |
| Sponsor: | Orthofix Srl |
| Via delle Nazioni 9 | |
| 37012 Bussolengo (VR) | |
| Italy | |
| Contact: | Orthofix |
| Troy Brooks, RAC | |
| Tel: 214-937-2047 | |
| Fax: 214-937-3322 | |
| Trade Name / | |
| Proprietary Name: | Orthofix Ankle Hindfoot Nailing System |
| Common Name: | Intramedullary Nail |
| Product Code: | HSB - Rod, Fixation, Intramedullary And Accessories |
| Classification: | Class II - 21 CFR § 888.3020 - Intramedullary Fixation Rod |
| Predicate Device: | Biomet Phoenix Ankle Arthrodesis Nail System – K091976 |
| Device Description: | The Orthofix Ankle Hindfoot Nailing System comprises a variety of |
| implantable intramedullary nails with respective locking end caps and | |
| locking screws manufactured from titanium alloy (Ti6Al4V) which are | |
| intended to facilitate tibiotalocalcaneal arthrodesis (fusion). The system | |
| also includes instrumentation required for implantation and explantation | |
| of the implants. | |
| Intended Use / | |
| Indications For Use: | The Orthofix Ankle Hindfoot Nailing System is intended to facilitate |
| tibiotalocalcaneal arthrodesis (fusion). Specific indications include: |
- Avascular necrosis of the talus
- Failed total ankle arthroplasty
- Trauma (malunited tibial pilon fracture)
- Severe deformity or instability as a result of talipes equinovarus,
cerebral vascular accident, paralysis or other neuromuscular disease - Revision ankle arthrodesis
- Neuroarthropathy
- Rheumatoid arthritis
- Osteoarthritis
- Pseudoarthrosis
- Post-traumatic arthrosis
- Previously infected arthrosis
- Charcot foot
- Severe endstage degenerative arthritis
- Severe defects after tumor resection
- Pantalar arthrodesis |
| Technological
Characteristics | The technological characteristics of the Orthofix Ankle Hindfoot Nailing
System are similar to the predicate device in terms of general design |
Summary:
dimensions, intended use, materials, and performance characteristics.
5
Image /page/5/Picture/0 description: The image shows the logo for Orthofix. The logo consists of a blue, abstract shape on the left, followed by the word "ORTHOFIX" in bold, black letters. A small registration mark is present to the right of the word "ORTHOFIX".
The following technological differences exist between the Orthofix Ankle Hindfoot Nailing System and the predicate device:
- The intramedullary nails have a distal flare
- The intramedullary nails have additional fixation points in some lengths
- The intramedullary nails have a smaller inner diameter
System is substantially equivalent to the predicate device.
- The locking screws are also offered in a threaded-head version
- The locking screws are also offered in lengths of 115mm and 120mm
| Non-Clinical Testing: | Mechanical testing of the Orthofix Ankle Hindfoot Nailing System
consisting of Static Four-Point Bend testing, Static Torsion testing, and
Bending Fatigue testing was conducted in accordance with ASTM F1264-
03 “Standard Specification and Test Methods for Intramedullary Fixation
Devices.” Test results demonstrate that the Orthofix Ankle Hindfoot
Nailing System is substantially equivalent to the predicate device. |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial: | Based upon similarities in design, materials, intended use, indications for |
| Equivalence: | use and the results of mechanical testing, the Orthofix Hindfoot Nailing |