(42 days)
Not Found
No
The document describes a mechanical implant (nail and screws) for bone fusion and trauma treatment. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are mechanical tests, not algorithmic performance metrics.
Yes
The device is intended for the treatment of various medical conditions, including arthritis, trauma, and deformities, and provides rigid fixation for arthrodesis procedures in the hindfoot and distal tibia.
No
The device is a Panta® Nail system, which is a medical implant intended for surgical fixation in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Its function involves providing rigid, load-sharing fixation and compression, not diagnosing conditions.
No
The device description clearly describes a physical implant (nail, screws, end caps) used for surgical fixation, not a software application.
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 about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The PANTA® Nail system is a surgical implant (a nail and screws) used to fix bones together during surgery. It is a physical device inserted into the body.
- Intended Use: The intended use clearly describes a surgical procedure (arthrodesis and treatment of trauma) involving the physical manipulation and fixation of bones. It does not involve the analysis of biological specimens.
The description of the device, its intended use, and the anatomical sites involved all point to it being a surgical implant/orthopedic device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The PANTA® Nail system is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Examples include:
- Post-traumatic and degenerative arthritis involving both ankle and subtalar joints
- Rheumatoid arthritis
- Revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body
- Revision of failed total ankle arthroplasty with subtalar intrusion
- Talar deficiency conditions (requiring a tibiocalcaneal arthrodesis)
- Avascular necrosis of the talus
- Neuroarthropathy or neuropathic ankle deformity
- Severe deformity as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
- Severe pilon fractures with trauma to the subtalar joint.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The modified Panta® Nail (dia. 10mm and XL) is ideally suited for tibiotalocalcaneal fusion indications. These Nails affords rigid, load sharing fixation that incorporates a simple nailmounted, in-line method of compression across the arthrodesis site.
The Panta® Nail (dia. 10mm and XL) affords even more torsional rigidity and better calcaneal purchase through its two transcalcaneal locking screws that are inserted from posterior to anterior, using a nail-mounted targeting device. Calcaneal screws eliminate significant rotation, preventing the calcaneus from "rocking" on the nail during weight-bearing. Some screws allow a sufficient stability for the fixation between calcaneus, talus and tibia.
The Panta® Nail (dia. 10mm and XL) is provided with sterile end caps which sit flush to the end of the nail and protect the internal threads from tissue ingrowth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hindfoot and distal tibia, ankle and subtalar joints
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 tests have been carried out. Results have shown that the mechanical properties of the modified Panta® Nail (dia. 10mm and XL) is equivalent to the properties of the unmodified device Newdeal Ankle Nail, K050882.
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.
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
510(k) SUMMARY Newdeal Panta® Nail (dia. 10mm) Newdeal Panta® Nail XL
Submitter's name and address:
JUL 2 9 2009
Newdeal SAS Immeuble Séquoïa 2 97 allée Alexandre Borodine Parc Technologique de la Porte des Alpes 69800 Saint Priest - FRANCE Tel: +33 4 37 47 51 51 Fax: +33 4 37 47 51 52
Contact person and telephone number
Marilyse LATOUR Regulatory Affairs Manager - EMEA Newdeal SAS Immeuble Séquoïa 2 97 allée Alexandre Borodine Parc Technologique de la Porte des Alpes 69800 Saint Priest- FRANCE Tel: +33 4 37 47 51 5 Fax: +33 4 37 47 51 52
Alternate Contacts Authorized Agent in the United States
Judith E. O'Grady, RN, MSN Sr. Vice President, Regulatory Affairs, Quality Assurance and Clinical Affairs Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536, USA Tel: (609) 936-2311 Fax: (609) 275-9445 E-mail : jogrady@integra-ls.com
Date Summary was prepared
June 10, 2009
Name of the devices :
Newdeal Panta® Nail Proprietary Name: . Common Name: Ankle nail Classification Name: Rod, Fixation, Intramedullary and Accessories (21CFR888.3020) Device Product Code:HSB Classification Panel: Orthopedic
1
Substantial Equivalence:
The modified Panta® Nail (dia. 10 mm and XL) is substantially equivalent to commercially marketed device Newdeal Ankle Nail (K050882), Depuy ACE VersaNail (K023115) and BIOMET Ankle Arthrodesis Nail (K021786).
Device description
The modified Panta® Nail (dia. 10mm and XL) is ideally suited for tibiotalocalcaneal fusion indications. These Nails affords rigid, load sharing fixation that incorporates a simple nailmounted, in-line method of compression across the arthrodesis site.
The Panta® Nail (dia. 10mm and XL) affords even more torsional rigidity and better calcaneal purchase through its two transcalcaneal locking screws that are inserted from posterior to anterior, using a nail-mounted targeting device. Calcaneal screws eliminate significant rotation, preventing the calcaneus from "rocking" on the nail during weight-bearing. Some screws allow a sufficient stability for the fixation between calcaneus, talus and tibia.
The Panta® Nail (dia. 10mm and XL) is provided with sterile end caps which sit flush to the end of the nail and protect the internal threads from tissue ingrowth.
Intended Use
The PANTA® Nail system is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Examples include:
- Post-traumatic and degenerative arthritis involving both ankle and subtalar joints
- Rheumatoid arthritis
- Revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body
- Revision of failed total ankle arthroplasty with subtalar intrusion
- Talar deficiency conditions (requiring a tibiocalcaneal arthrodesis)
- Avascular necrosis of the talus
- Neuroarthropathy or neuropathic ankle deformity
- Severe deformity as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
- Severe pilon fractures with trauma to the subtalar joint.
Testing and Test Results:
Mechanical tests have been carried out. Results have shown that the mechanical properties of the modified Panta® Nail (dia. 10mm and XL) is equivalent to the properties of the unmodified device Newdeal Ankle Nail, K050882.
Conclusion
The modified Newdeal Panta® Nail (dia. 10mm and XL) is subsequently equivalent to commercially marketed device, Newdeal Ankle Nail (K050882), Depuy ACE VersaNail (K023115) and BIOMET Ankle Arthrodesis Nail (K021786).
The modifications do not change the intended use or fundamental scientific technology of the device and do not raise any new issues of safety or effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the eagle. The eagle is depicted in a simple, black-and-white design, and the text is in a sans-serif font.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Newdeal SAS % Mr. Frederic Testa Sr. Regulatory Affairs Project Manager Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, New Jersey 08536
11.1. 9. 9. 2005
Re: K091788
Trade/Device Name: Newdeal Panta® Nail (10 mm and Panta® Nail XL) System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: July 8, 2009 Received: July 9, 2009
Dear Mr. Testa:
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.
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
3
Page 2 - Mr. Frederic Testa
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 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Oboibazbuehuro
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known) : KO91788
Panta® Nail Device Name:
-
Índications For Use: Panta® Nail .
The PANTA® Nail system is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Examples include: -
Post-traumatic and degenerative arthritis involving both ankle and subtalar joints
-
Rheumatoid arthritis
-
Revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body
-
Revision of failed total ankle arthroplasty with subtalar intrusion
-
Talar deficiency conditions (requiring a tibiocalcaneal arthrodesis)
-
Avascular necrosis of the talus
-
Neuroarthropathy or neuropathic ankle deformity
-
Severe deformity as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
-
Severe pilon fractures with trauma to the subtalar joint.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Sonita for mxm
(Division Sign-Off)
Division of Surgica! Orthopedic. and Restorative Devices
510(k) Number K091788