(185 days)
Not Found
No
The description focuses on the material, dimensions, and mechanical properties of the implant and associated instruments, with no mention of AI/ML capabilities or data processing.
Yes
The device is indicated for tibiotalocalcaneal arthrodesis (fusion) to treat various medical conditions such as avascular necrosis, failed total ankle arthroplasty, and severe deformity, which are therapeutic interventions.
No
The device is described as an arthrodesis nail system used for fusion, providing structural support rather than diagnosing conditions.
No
The device description clearly states that the system includes nails, interlocking screws, and instruments, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Piccolo Composite Ankle Arthrodesis Nails are implants designed to fuse bones in the ankle. They are physical devices inserted into the body during surgery.
- Intended Use: The intended use is for surgical fusion of the tibiotalocalcaneal joint, addressing various orthopedic conditions. This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The information provided clearly describes a surgical implant and its intended use in orthopedic surgery, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Piccolo Composite Ankle Arthrodesis Nails
The Piccolo Composite Ankle Arthrodesis Nails are indicated for 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
HSB
Device Description
The Piccolo Composite Ankle Arthrodesis Nailing System includes nails, interlocking screws and a set of instruments.
The Piccolo Composite Ankle Arthrodesis Nail is a cannulated, cylindrical rod. made of carbon fiber reinforced polymer. Nail diameter ranges from 10mm to 12mm, with lengths in the range of 160mm to 240mm. The nails provide for holes at the proximal and distal sections, designed for the insertion of self-tapping, titanium-alloy-made, interlocking screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
talus, tibiotalocalcaneal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Evaluation of expected performance characteristics, such as bending and torsion parameters for the Piccolo Composite ankle arthrodesis nails was based on comparison to predicate devices, per ASTM F 1264 - Standard Specification and Test Methods for Intramedullary Fixation Devices. Evaluation in support of MR Conditional labeling parameters was also provided. All the above demonstrate that the device is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K102369, K111056, K081243, K091976, K090857
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
510(K) Summary
JUN 1 4 2013
CarboFix Orthopedics Ltd.
Piccolo Composite® Nailing System - Ankle Arthrodesis
Applicant Name
CarboFix Orthopedics Ltd.
11 Ha'hoshlim St., Herzeliya 46724, Israel
Contact Person
Yael Rubin CarboFix Orthopedics Ltd. 11 Ha'hoshlim St., Herzliya 46724, Israel Tel: +972 9 9511511, Fax: +972 9 9548939
Date Prepared
May 2013
Trade/Proprietary Name
Piccolo Composite Nailing System
Common Name
Intramedullary Nailing System
Classification Name
Rod, Fixation, Intramedullary and Accessories (21 CFR §888.3020; Product Code HSB)
Predicate Devices
1
K123810
CarboFix Orthopedics Ltd. Piccolo Composite® Nailing System - Ankle Arthrodesis
- Phoenix Ankle Arthrodesis Nailing System (Biomet Trauma; K081243, K091976)
- Valor® Ankle Fusion Nail System (Wright Medical Technology, Inc .; K090857)
Intended Use/Indications for Use
Piccolo Composite Ankle Arthrodesis Nails
The Piccolo Composite Ankle Arthrodesis Nails are indicated for 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
- l 4. Severe defects after tumor resection
-
- Pantalar arthrodesis
System Description
The Piccolo Composite Ankle Arthrodesis Nailing System includes nails, interlocking screws and a set of instruments.
The Piccolo Composite Ankle Arthrodesis Nail is a cannulated, cylindrical rod. made of carbon fiber reinforced polymer. Nail diameter ranges from 10mm to 12mm, with lengths
2
CarboFix Orthopedics Ltd. Piccolo Composite® Nailing System - Ankle Arthrodesis
in the range of 160mm to 240mm. The nails provide for holes at the proximal and distal sections, designed for the insertion of self-tapping, titanium-alloy-made, interlocking screws.
Substantial Equivalence
The Piccolo Composite Nailing System intended use, design, materials, technological characteristics, and principles of operation are substantially equivalent to those of the predicate devices, as applicable.
Evaluation of expected performance characteristics, such as bending and torsion parameters for the Piccolo Composite ankle arthrodesis nails was based on comparison to predicate devices, per ASTM F 1264 - Standard Specification and Test Methods for Intramedullary Fixation Devices. Evaluation in support of MR Conditional labeling parameters was also provided. All the above demonstrate that the device is safe and effective for its intended use.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public I lea th Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 14, 2013
CarboFix Orthopedics Limited % Ms. Yael Rubin Director of Regulatory Alfairs 11 Ha'hoshlim Street Herzeliya 46724 Israel
Re: K123810
Trade/Device Name: Piccolo Composite™ Nailing System Regulation Nur iber: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: May 12, 2013 Received: May 14, 2013
Dear Ms. Rubin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above ard 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 Amend:nents, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and-Gosmetic-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. Pleas : note: CDRH docs not evaluate information related to contract liability warranties. We rer ind you; however that device labeling must be truthful and not misleading.
If your device is classified (see above) into cither 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); lateling (21 CFR Part 801); medical device reporting (reporting of medical
4
Page 2 – Ms. Yael Rubin
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 301), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 CDKH's Office of Surveillance and 3iometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance 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.
For
Sincerely yours.
Erin |. Keith
Mark N. Melkerson Director Division.of Orthopedic_Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indication for Use
510(K) Number (if known):
Piccolo Composite® Nailing System Device Name:
Indication for Use:
Piccolo Composite Ankle Arthrodesis Nails
The Piccolo Composite Ankle Arthrodesis Nails are indicated for 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 4. accident, paralysis or other neuromuscular disease
-
- Revision ankle arthrodesis
-
- Neuroarthropathy
-
- Rheumatoid arthritis
- Osteoarthritis 8.
-
- Pseudoarthrosis
-
- Post-traumatic arthrosis
-
- Previously infected arthrosis
-
- Charcot foot
-
- Severe endstage degenerative arthritis
-
- Severe defects after tumor resection
- 15 .- Pantalar-arthrodesis
Prescription Use
AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices