(266 days)
No
The device description and performance studies focus on the mechanical properties and surgical application of an intramedullary nail system, with no mention of AI or ML technologies.
Yes
The device is an implantable system of fusion nails and bone screws intended for specific orthopedic conditions such as Charcot foot and severe end-stage degenerative arthritis, aiming to provide structural support and promote bone fusion to treat debilitating conditions. This therapeutic function directly addresses and alleviates disease states or injuries.
No
Explanation: The Shotel Ankle Arthrodesis Nail System is described as an "implantable intramedullary system of fusion nails, bone screws, a nail cap and a set of instruments for primary ankle fusion." It is a surgical implant designed for treatment, not for diagnosing conditions.
No
The device description clearly states it is an "implantable intramedullary system of fusion nails, bone screws, a nail cap and a set of instruments," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system for fusing bones in the ankle to treat various conditions. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description details an implantable system made of titanium, including nails, screws, and instruments for surgical implantation. This aligns with a surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition based on laboratory analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Shotel Ankle Arthrodesis Nail System is a surgical implant used to treat a condition, not to diagnose it.
N/A
Intended Use / Indications for Use
The Shotel Ankle Arthrodesis Nail System is intended for the following:
- Charcot Foot
- Avascular necrosis of the talus
- Failed total ankle arthroplasty
- Trauma (malunited tibial pilon fracture)
- Severe deformity or instability as a result of talipes equinoivarus, cerebral vascular accident, paralysis or other neuromuscular disease
- Revision ankle arthrodesis
- Neuroarthropathy
- Rheumatoid arthritis
- Osteoarthritis
- Pseudoarthrosis
- Post-Traumatic arthrosis
- Previously infected arthrosis
- Severe end stage degenerative arthritis
- Severe defects after tumor resection
- Pantalar arthrodesis
Product codes
HSB
Device Description
The Shotel Ankle Arthrodesis Nail System is an implantable intramedullary system of fusion nails, bone screws, a nail cap and a set of instruments for primary ankle fusion. The curved fusion nail has 6 screw holes that can accommodate up to 6 bone screws and is available in seven (7) diameters in two configurations, left and right. The four (4) distal cross locking holes provide the surgeon with either a static or dynamic cross locking hole in alternative 90 degree orientation configurations. The 5mm fixation bone screws are offered in 27 lengths and the nail caps are available in two configurations; standard nail cap length and a plus 5 mm nail cap length affording the surgeon the ability to slightly adjust the final nail assembly length. All three implant components are manufactured from titanium Ti-6Al-4V and are single use only. Components are offered sterile and non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ankle
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
All necessary testing has been performed with the Shotel Ankle Arthrodesis Nail System to assure substantial equivalence to the predicate devices. Testing included primary stiffness, fusion-site compression, primary bending stiffness and mechanical and fatigue testing in accordance with ASTM F1264. Pyrogen testing was performed on the subject implants and it was confirmed that the implants meet the 20 EU/device testing limit.
Key Metrics
Not Found
Predicate Device(s)
Ascension® Ankle Fusion Nail System - K100925, Howmedica Osteonics Asnis III Cannulated Screw System (K000080), Nexa Orthopedics Nexa Bone Screw System (K053394)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 13, 2017
Biopro, Inc. % Al Memmolo President Convergent Clinical, Inc. 6648 Surf Crest St. Carlsbad, California 92011
Re: K163627
Trade/Device Name: Shotel Ankle Arthrodesis Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: August 10, 2017 Received: August 11, 2017
Dear Al Memmolo:
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,
Vincent J. Devlin -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017 See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K163627
Device Name Shotel Ankle Arthrodesis Nail System
Indications for Use (Describe)
The Shotel Ankle Arthrodesis Nail System is intended for the following:
- Charcot Foot
- Avascular necrosis of the talus
- Failed total ankle arthroplasty ●
- . Trauma (malunited tibial pilon fracture)
- Severe deformity or instability as a result of talipes equinoivarus, cerebral vascular accident, paralysis or other neuromuscular disease
- Revision ankle arthrodesis
- Neuroarthropathy
- Rheumatoid arthritis
- Osteoarthritis
- Pseudoarthrosis
- Post-Traumatic arthrosis
- Previously infected arthrosis
- Severe end stage degenerative arthritis
- Severe defects after tumor resection
- o Pantalar arthrodesis
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)
[ ] Over-The-Counter Use (21 CFR 801
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (8/14)
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Image /page/2/Picture/35 description: The image shows the logo for BIOPRO, which stands for Biologically Oriented Prostheses. Below the logo, the text "Shotel Ankle Arthrodesis Nail System" is displayed. The logo and text are in a simple, professional font.
Premarket Notification 510(k)
3
Image /page/3/Picture/1 description: The image shows the logo for Biopro, which stands for Biologically Oriented Prostheses. The logo is in black and white, with the word "BIOPRO" in large, bold letters. The "O" in "BIOPRO" is split in half, with one half being black and the other half being white. Above the word "BIOPRO" are the words "BIOLOGICALLY ORIENTED PROSTHESES" in smaller letters.
GENERAL INFORMATION
| APPLICANT: | BioPro, Inc.
2929 Lapeer Road
Port Huron, MI 48060 |
|-----------------|--------------------------------------------------------------|
| CONTACT PERSON: | Al Memmolo
Convergent Clinical, Inc
Carlsbad, CA 92011 |
Date Prepared: August 10, 2017
Device Description
| TRADE NAME: | Shotel Ankle Arthrodesis Nail System |
|---|---|
| COMMON NAME: | Intramedullary Nail |
| PRODUCT CODE: | HSB - Rod, Fixation, Intramedullary And Accessories |
| CLASSIFICATION: | Class II – 21 CFR § 888.3020 – Intramedullary Fixation Rod |
| PREDICATE DEVICES: | Ascension® Ankle Fusion Nail System - K100925 |
| Howmedica Osteonics Asnis III Cannulated Screw System (K000080) | |
| Nexa Orthopedics Nexa Bone Screw System (K053394) |
Product Description
The Shotel Ankle Arthrodesis Nail System is an implantable intramedullary system of fusion nails, bone screws, a nail cap and a set of instruments for primary ankle fusion. The curved fusion nail has 6 screw holes that can accommodate up to 6 bone screws and is available in seven (7) diameters in two configurations, left and right. The four (4) distal cross locking holes provide the surgeon with either a static or dynamic cross locking hole in alternative 90 degree orientation configurations. The 5mm fixation bone screws are offered in 27 lengths and the nail caps are available in two configurations; standard nail cap length and a plus 5 mm nail cap length affording the surgeon the ability to slightly adjust the final nail assembly length. All three implant components are manufactured from titanium Ti-6Al-4V and are single use only. Components are offered sterile and non-sterile.
4
Image /page/4/Picture/1 description: The image shows the logo for BIOPRO, which stands for Biologically Oriented Prostheses. The logo is in black and white, with the letters "BIO" in white on a black background and the letters "PRO" in black on a white background. The letters are in a bold, sans-serif font. The logo is simple and modern.
INDICATIONS FOR USE
The Shotel Ankle Arthrodesis Nail System is intended for the following:
- . Charcot Foot
- Avascular necrosis of the talus
- . Failed total ankle arthroplasty
- Trauma (malunited tibial pilon fracture) ●
- . Severe deformity or instability as a result of talipes equinoivarus, cerebral vascular accident, paralysis or other neuromuscular disease
- . Revision ankle arthrodesis
- . Neuroarthropathy
- Rheumatoid arthritis
- . Osteoarthritis
- . Pseudoarthrosis
- Post-Traumatic arthrosis
- . Previously infected arthrosis
- Severe end stage degenerative arthritis
- . Severe defects after tumor resection
- Pantalar arthrodesis
TECHNOLOGICAL CHARACTERISTICS
The Shotel Ankle Arthrodesis Nail System has similar physical and technological characteristics to the predicate devices since all implantable devices are manufactured from the same material and have the same principle of operation; fixation of fractures, fusions, or osteotomies, of bones.
Performance Data
All necessary testing has been performed with the Shotel Ankle Arthrodesis Nail System to assure substantial equivalence to the predicate devices. Testing included primary stiffness, fusion-site compression, primary bending stiffness and mechanical and fatigue testing in accordance with ASTM F1264. Pyrogen testing was performed on the subject implants and it was confirmed that the implants meet the 20 EU/device testing limit.
SUBSTANTIAL EQUIVALENCE
Upon reviewing the technical information provided in this submission and comparing intended use, principle of operation, performance data, and overall technological characteristics, the Shotel Ankle Arthrodesis Nail System is determined to be substantially equivalent to existing legally marketed devices.