The Panta 2 Nail Arthrodesis System is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Indications 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 Panta 2 Arthrodesis Nail System (Panta 2) is used to perform a tibio-talo- calcaneal arthrodesis, a procedure undertaken for hindfoot problems that affect both the ankle and subtalar joints. The aim is to achieve fusion of the bones using a retrograde Nail that allows re-alignment of the foot on the weight-bearing axis, correction of coronal and sagittal plane deformities, rotational stability as well as axial compression. The Panta 2 System includes instrumentation which allows placement of screws through the central Nail and enables application of compression along with multi-planar screw fixation in the tibia, the talus, and the calcaneus.

AI/ML Overview

The Panta 2 Arthrodesis Nail System is a medical device intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. The device's acceptance was based on non-clinical performance data, demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Testing Description)	Standard	Reported Device Performance (Results)
Nail - Bending Static Comparison Test	ASTM F1264	The Panta 2 System Nail performed substantially equivalent when compared to the predicate system Nail.
Nail - Bending Fatigue Life Comparison Test	ASTM F1264	The Panta 2 System Nail performed substantially equivalent when compared to the predicate system Nail.
Nail - Static Torsional Strength Comparison Test	ASTM F1264	The Panta 2 System Nail performed substantially equivalent when compared to the predicate system Nail.
Screws - Bending Fatigue Strength Test	ASTM F1264	The Panta 2 System screws performed substantially equivalent when compared to the predicate system screws.
Screws - Torsional Properties Test	ASTM F543	The Panta 2 System screws performed to requirements of the identified standards.
Screws – Axial Pullout Strength Test	ASTM F543	The Panta 2 System screws performed to requirements of the identified standards.

2. Sample size used for the test set and the data provenance:

The document does not specify the exact sample sizes (e.g., number of nails or screws) used for each mechanical test. The data provenance is non-clinical, meaning it comes from laboratory testing of the devices themselves, not from patient data. Therefore, there is no information about country of origin or whether it's retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device's acceptance was based on non-clinical, mechanical testing, not a clinical study involving human or expert interpretation of data. The "ground truth" here is the performance against established engineering standards.

4. Adjudication method for the test set:

Not applicable. As the acceptance was based on non-clinical mechanical testing results, no human adjudication method was used. The device's performance was objectively measured against the specified standards.

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 mechanical implant device, not an AI-powered diagnostic or assistive technology that would involve human readers.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:

Not applicable. This is a mechanical implant device and does not involve algorithms or AI.

7. The type of ground truth used:

The ground truth for the device's performance was established through recognized industry standards for medical implants (ASTM F1264 and ASTM F543). These standards define the expected mechanical properties and performance of intramedullary fixation rods and bone screws.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not a machine learning or AI-based device.

9. How the ground truth for the training set was established:

Not applicable. As there is no training set for this device type, there is no ground truth established for it.

Summary

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November 2, 2018 Integra Lifesciences Corporation Blesson Abraham Senior Regulatory Affairs Associate 11101 Metric Blvd. Austin, Texas 78758

Re: K181639

Trade/Device Name: Panta 2 Arthrodesis Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: October 10, 2018 Received: October 12, 2018

Dear Blesson Abraham:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K181639

Device Name Panta 2 Nail Arthrodesis System

The Panta 2 Nail Arthrodesis System is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Indications 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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Sponsor	Integra Lifesciences Corp.Ascension Orthopedics, Inc.11101 Metric Blvd.Austin, TX 78758
EstablishmentNumber	3014207283
Point of Contact	Blesson AbrahamSenior Regulatory Affairs Specialist11101 Metric Blvd.Austin, TX 78758512-368-1423
Date	July 10, 2018
Trade Name	Panta 2 Arthrodesis Nail System
ClassificationName	Intramedullary Fixation Rod
ClassificationPanel	Orthopedic
Classification	Class II
Regulation	21 CFR 888.3020
Product Code	HSB
Predicate Device	K091788Newdeal Panta® Nail (10 mm and Panta® Nail XL) System, currently marketedunder Integra as the Panta Arthrodesis Nail System.
DeviceDescription	The Panta 2 Arthrodesis Nail System (Panta 2) is used to perform a tibio-talo-calcaneal arthrodesis, a procedure undertaken for hindfoot problems that affectboth the ankle and subtalar joints. The aim is to achieve fusion of the bones usinga retrograde Nail that allows re-alignment of the foot on the weight-bearing axis,correction of coronal and sagittal plane deformities, rotational stability as well asaxial compression. The Panta 2 System includes instrumentation which allowsplacement of screws through the central Nail and enables application ofcompression along with multi-planar screw fixation in the tibia, the talus, and thecalcaneus.

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Integra Lifesciences Corporation – Special 510(k)

Integra Panta 2 Arthrodesis Nail System

Intended Use/Indications for Use	The Panta 2 Arthrodesis Nail System is intended for use in tibiotalocalcanealarthrodesis and treatment of trauma to the hindfoot and distal tibia. Indicationsinclude: Post-traumatic and degenerative arthritis involving both ankle and subtalarjoints Rheumatoid arthritis Revision of failed ankle arthrodesis with subtalar involvement or withinsufficient 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 vascularaccident, paralysis or other neuromuscular disease Severe pilon fractures with trauma to the subtalar joint.
NonclinicalPerformance Data	The Panta 2 Arthrodesis Nail System implants were subjected to verificationtesting per required standards to establish substantial equivalent performance incomparison to the predicate device.
	No.	Testing Description	Standard	Results
	1	Nail - BendingStatic ComparisonTest	ASTM F1264	The Panta 2 System Nailperformed substantiallyequivalent when compared to thepredicate system Nail.
	2	Nail - BendingFatigue LifeComparison Test	ASTM F1264
	3	Nail - StaticTorsional StrengthComparison Test	ASTM F1264
	4	Screws - BendingFatigue StrengthTest	ASTM F1264	The Panta 2 System screwsperformed substantiallyequivalent when compared to thepredicate system screws.
	5	Screws - TorsionalProperties Test	ASTM F543	The Panta 2 System screwsperformed to requirements of theidentified standards.
	6	Screws – AxialPullout StrengthTest	ASTM F543
Clinical	Clinical performance data is not required to demonstrate substantial equivalence

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Integra Lifesciences Corporation – Special 510(k)

Integra Panta 2 Arthrodesis Nail System

SubstantialEquivalenceConclusion	Basis of substantial equivalence of the modified device and predicate deviceestablished on the following:The Panta 2 and Panta 1 Systems have the following similarities:Both systems have the same Indications for Use. The intended patientpopulation and indications for use of the Panta 1 Arthrodesis NailSystem are unchanged. Both systems operate using the same fundamental scientific technology. Both systems incorporate the same basic implant design. Both systems use the same methods of sterilization. Both systems use the same operational principles for the surgicalimplantation of the IM Nails, Screws, and End Caps. The Panta 2 and Panta 1 have the following differences: Conformance to implant material from ISO 5832 to ASTM 136 Minor dimensional differences in the nail design Additional screw sizes added for fully threaded screws Reduce available sizes of partially threaded screws Minor change to the anodization and dimensional characteristics of thescrews Reduce available end cap sizes and modify anodization of the end cap Evaluation of the risks and performance data based on the differences betweenthe subject device and predicate does not raise any new issues or concerns relatedto safety or effectiveness. It is concluded that the modified device, the Panta 2Arthrodesis Nail System, is as safe and effective as the predicate device for itsintended use, and is substantially equivalent to the legally marketed predicatedevice, the Newdeal Panta® Nail (10 mm and Panta® Nail XL) System.
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SubstantialEquivalenceConclusion

Basis of substantial equivalence of the modified device and predicate deviceestablished on the following:The Panta 2 and Panta 1 Systems have the following similarities:Both systems have the same Indications for Use. The intended patientpopulation and indications for use of the Panta 1 Arthrodesis NailSystem are unchanged. Both systems operate using the same fundamental scientific technology. Both systems incorporate the same basic implant design. Both systems use the same methods of sterilization. Both systems use the same operational principles for the surgicalimplantation of the IM Nails, Screws, and End Caps. The Panta 2 and Panta 1 have the following differences: Conformance to implant material from ISO 5832 to ASTM 136 Minor dimensional differences in the nail design Additional screw sizes added for fully threaded screws Reduce available sizes of partially threaded screws Minor change to the anodization and dimensional characteristics of thescrews Reduce available end cap sizes and modify anodization of the end cap Evaluation of the risks and performance data based on the differences betweenthe subject device and predicate does not raise any new issues or concerns relatedto safety or effectiveness. It is concluded that the modified device, the Panta 2Arthrodesis Nail System, is as safe and effective as the predicate device for itsintended use, and is substantially equivalent to the legally marketed predicatedevice, the Newdeal Panta® Nail (10 mm and Panta® Nail XL) System.

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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.