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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Newdeal Panta® Nail (dia. 10mm) Newdeal Panta® Nail XL." This submission primarily focuses on establishing substantial equivalence to existing predicate devices based on mechanical testing, rather than clinical performance or AI algorithm effectiveness. Therefore, many of the requested categories related to AI performance, expert consensus, and human-in-the-loop studies are not applicable or cannot be extracted from this document.

Here's the information that can be extracted and a clear indication where information is not available:

{
  "1. A table of acceptance criteria and the reported device performance": {
    "Acceptance Criteria": [
      "Mechanical properties equivalent to the unmodified device Newdeal Ankle Nail, [K050882](https://510k.innolitics.com/search/K050882)."
    ],
    "Reported Device Performance": [
      "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](https://510k.innolitics.com/search/K050882)."
    ]
  },
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "This information is not provided in the document. The study involved mechanical tests, not a clinical test set with patient data.",
  "3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "Not applicable. The study involved mechanical testing, not expert consensus on medical images or patient outcomes.",
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable. The study involved mechanical testing.",
  "5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance": "Not applicable. This is a medical device for surgical fixation, not an AI-powered diagnostic tool.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Not applicable. This is a medical device for surgical fixation, not an AI algorithm.",
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "The 'ground truth' for the mechanical testing was the established mechanical properties of the predicate device (Newdeal Ankle Nail, [K050882](https://510k.innolitics.com/search/K050882)).",
  "8. The sample size for the training set": "Not applicable. This document describes mechanical testing for a physical medical device, not an AI model requiring a training set.",
  "9. How the ground truth for the training set was established": "Not applicable. This document describes mechanical testing for a physical medical device, not an AI model requiring a training set."
}

Summary

{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 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

Regulation Number and Section

§ 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.