Panta 2 Arthrodesis Nail System

K181639 · Integra LifeSciences Corporation · HSB · Nov 2, 2018 · Orthopedic

Device Facts

• Record ID: K181639
• Device Name: Panta 2 Arthrodesis Nail System
• Applicant: Integra LifeSciences Corporation
• Product Code: HSB · Orthopedic
• Decision Date: Nov 2, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Panta 2 Arthrodesis Nail 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 Story

Panta 2 Arthrodesis Nail System is a retrograde intramedullary nail system for hindfoot arthrodesis. Device consists of a central nail, screws, and end caps. Used by orthopedic surgeons in clinical settings to achieve bone fusion, re-align the foot on the weight-bearing axis, correct coronal/sagittal plane deformities, and provide rotational stability and axial compression. Instrumentation allows multi-planar screw fixation in the tibia, talus, and calcaneus. Output is mechanical stabilization of the hindfoot to facilitate fusion and treat trauma. Benefits include improved structural alignment and stability for patients with severe hindfoot pathology.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing per ASTM F1264 and ASTM F543 standards, including static/fatigue bending, torsional strength, and axial pullout testing.

Technological Characteristics

Intramedullary fixation rod system. Materials: Titanium alloy (ASTM F136). Components: Retrograde nail, screws, end caps. Mechanical principle: Axial compression and multi-planar screw fixation. Sterilization: Not specified. Connectivity: None (mechanical device).

Indications for Use

Indicated for patients requiring tibiotalocalcaneal arthrodesis or treatment of hindfoot/distal tibia trauma, including those with post-traumatic/degenerative arthritis, rheumatoid arthritis, failed ankle arthrodesis/arthroplasty, talar deficiency, avascular necrosis, neuroarthropathy, severe deformities (talipes equinovarus, paralysis, CVA), or severe pilon fractures.

Regulatory Classification

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.

Predicate Devices

• Newdeal Panta® Nail (10 mm and Panta® Nail XL) System (K091788)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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.<br>Ascension Orthopedics, Inc.<br>11101 Metric Blvd.<br>Austin, TX 78758 |
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| Establishment<br>Number | 3014207283 |
| Point of Contact | Blesson Abraham<br>Senior Regulatory Affairs Specialist<br>11101 Metric Blvd.<br>Austin, TX 78758<br>512-368-1423 |
| Date | July 10, 2018 |
| Trade Name | Panta 2 Arthrodesis Nail System |
| Classification<br>Name | Intramedullary Fixation Rod |
| Classification<br>Panel | Orthopedic |
| Classification | Class II |
| Regulation | 21 CFR 888.3020 |
| Product Code | HSB |
| Predicate Device | K091788<br>Newdeal Panta® Nail (10 mm and Panta® Nail XL) System, currently marketed<br>under Integra as the Panta Arthrodesis Nail System. |
| Device<br>Description | The Panta 2 Arthrodesis Nail System (Panta 2) is used to perform a tibio-talo-<br>calcaneal arthrodesis, a procedure undertaken for hindfoot problems that affect<br>both the ankle and subtalar joints. The aim is to achieve fusion of the bones using<br>a retrograde Nail that allows re-alignment of the foot on the weight-bearing axis,<br>correction of coronal and sagittal plane deformities, rotational stability as well as<br>axial compression. The Panta 2 System includes instrumentation which allows<br>placement of screws through the central Nail and enables application of<br>compression along with multi-planar screw fixation in the tibia, the talus, and the<br>calcaneus. |

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## Integra Lifesciences Corporation – Special 510(k)
Integra Panta 2 Arthrodesis Nail System

| Intended Use/<br>Indications for Use | The Panta 2 Arthrodesis Nail System is intended for use in tibiotalocalcaneal<br>arthrodesis and treatment of trauma to the hindfoot and distal tibia. Indications<br>include: Post-traumatic and degenerative arthritis involving both ankle and subtalar<br>joints Rheumatoid arthritis Revision of failed ankle arthrodesis with subtalar involvement or with<br>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<br>accident, paralysis or other neuromuscular disease Severe pilon fractures with trauma to the subtalar joint. | | | |
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| Nonclinical<br>Performance Data | The Panta 2 Arthrodesis Nail System implants were subjected to verification<br>testing per required standards to establish substantial equivalent performance in<br>comparison to the predicate device. | | | |
| | No. | Testing Description | Standard | Results |
| | 1 | Nail - Bending<br>Static Comparison<br>Test | ASTM F1264 | The Panta 2 System Nail<br>performed substantially<br>equivalent when compared to the<br>predicate system Nail. |
| | 2 | Nail - Bending<br>Fatigue Life<br>Comparison Test | ASTM F1264 | |
| | 3 | Nail - Static<br>Torsional Strength<br>Comparison Test | ASTM F1264 | |
| | 4 | Screws - Bending<br>Fatigue Strength<br>Test | ASTM F1264 | The Panta 2 System screws<br>performed substantially<br>equivalent when compared to the<br>predicate system screws. |
| | 5 | Screws - Torsional<br>Properties Test | ASTM F543 | The Panta 2 System screws<br>performed to requirements of the<br>identified standards. |
| | 6 | Screws – Axial<br>Pullout Strength<br>Test | 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

| Substantial<br>Equivalence<br>Conclusion | Basis of substantial equivalence of the modified device and predicate device<br>established on the following:<br><br>The Panta 2 and Panta 1 Systems have the following similarities:<br>Both systems have the same Indications for Use. The intended patient<br>population and indications for use of the Panta 1 Arthrodesis Nail<br>System 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 surgical<br>implantation 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 the<br>screws Reduce available end cap sizes and modify anodization of the end cap Evaluation of the risks and performance data based on the differences between<br>the subject device and predicate does not raise any new issues or concerns related<br>to safety or effectiveness. It is concluded that the modified device, the Panta 2<br>Arthrodesis Nail System, is as safe and effective as the predicate device for its<br>intended use, and is substantially equivalent to the legally marketed predicate<br>device, the Newdeal Panta® Nail (10 mm and Panta® Nail XL) System. |
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