(134 days)
Not Found
No
The description focuses on the mechanical aspects of the device (nail, screws, instrumentation) for surgical fusion and does not mention any software, algorithms, or data processing capabilities that would indicate AI/ML.
Yes
The device is described as a "Nail Arthrodesis System" which performs a surgical procedure for "hindfoot problems that affect both the ankle and subtalar joints" with the aim to "achieve fusion of the bones". This clearly indicates a direct medical intervention for a health condition.
No
The device description clearly states its purpose is for "tibiotalocalcaneal arthrodesis," a surgical procedure to achieve fusion of bones. It describes the physical components and their use in surgery, not in diagnosing conditions.
No
The device description clearly states it is a "Nail Arthrodesis System" and includes "instrumentation" and "screws," indicating it is a physical medical device, not software only. The performance studies also focus on the mechanical properties of the nail and screws.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system used for arthrodesis (fusion) of bones in the hindfoot and distal tibia. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a retrograde nail and screws used to achieve bone fusion and provide stability. This is a physical implant, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions based on these samples, or providing information for diagnosis, monitoring, or screening.
IVDs are devices used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The Panta 2 Nail Arthrodesis System is a surgical implant used for treatment, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
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.
Product codes
HSB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hindfoot and distal tibia
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)
Nonclinical Performance Data: The Panta 2 Arthrodesis Nail System implants were subjected to verification testing per required standards to establish substantial equivalent performance in comparison to the predicate device.
Testing Description: Nail - Bending Static Comparison Test
Standard: ASTM F1264
Results: The Panta 2 System Nail performed substantially equivalent when compared to the predicate system Nail.
Testing Description: Nail - Bending Fatigue Life Comparison Test
Standard: ASTM F1264
Testing Description: Nail - Static Torsional Strength Comparison Test
Standard: ASTM F1264
Testing Description: Screws - Bending Fatigue Strength Test
Standard: ASTM F1264
Results: The Panta 2 System screws performed substantially equivalent when compared to the predicate system screws.
Testing Description: Screws - Torsional Properties Test
Standard: ASTM F543
Results: The Panta 2 System screws performed to requirements of the identified standards.
Testing Description: Screws – Axial Pullout Strength Test
Standard: ASTM F543
Clinical: Clinical performance data is not required to demonstrate substantial equivalence
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
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
1
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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Image /page/3/Picture/2 description: The image shows the logo for Integra. The word "INTEGRA" is written in gray, block letters. Below the word "INTEGRA" is the phrase "LIMIT UNCERTAINTY" in smaller, gray letters. To the right of the word "INTEGRA" is a design of green squares that are different sizes.
510(k) Summary
| Sponsor | Integra Lifesciences Corp.
Ascension Orthopedics, Inc.
11101 Metric Blvd.
Austin, TX 78758 |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Number | 3014207283 |
| Point of Contact | Blesson Abraham
Senior Regulatory Affairs Specialist
11101 Metric Blvd.
Austin, TX 78758
512-368-1423 |
| Date | July 10, 2018 |
| Trade Name | Panta 2 Arthrodesis Nail System |
| Classification
Name | Intramedullary Fixation Rod |
| Classification
Panel | Orthopedic |
| Classification | Class II |
| Regulation | 21 CFR 888.3020 |
| Product Code | HSB |
| Predicate Device | K091788
Newdeal Panta® Nail (10 mm and Panta® Nail XL) System, currently marketed
under Integra as the Panta Arthrodesis Nail System. |
| 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. |
4
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 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. | | | |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|------------|---------------------------------------------------------------------------------------------------------------------|
| Nonclinical
Performance Data | The Panta 2 Arthrodesis Nail System implants were subjected to verification
testing per required standards to establish substantial equivalent performance in
comparison to the predicate device. | | | |
| | No. | Testing Description | Standard | Results |
| | 1 | Nail - Bending
Static Comparison
Test | ASTM F1264 | The Panta 2 System Nail
performed substantially
equivalent when compared to the
predicate system Nail. |
| | 2 | Nail - Bending
Fatigue Life
Comparison Test | ASTM F1264 | |
| | 3 | Nail - Static
Torsional Strength
Comparison Test | ASTM F1264 | |
| | 4 | Screws - Bending
Fatigue Strength
Test | ASTM F1264 | The Panta 2 System screws
performed substantially
equivalent when compared to the
predicate system screws. |
| | 5 | Screws - Torsional
Properties Test | ASTM F543 | The Panta 2 System screws
performed to requirements of the
identified standards. |
| | 6 | Screws – Axial
Pullout Strength
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
Equivalence
Conclusion | Basis of substantial equivalence of the modified device and predicate device
established on the following:
The Panta 2 and Panta 1 Systems have the following similarities:
Both systems have the same Indications for Use. The intended patient
population and indications for use of the Panta 1 Arthrodesis Nail
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
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
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
the subject device and predicate does not raise any new issues or concerns related
to safety or effectiveness. It is concluded that the modified device, the Panta 2
Arthrodesis Nail System, is as safe and effective as the predicate device for its
intended use, and is substantially equivalent to the legally marketed predicate
device, the Newdeal Panta® Nail (10 mm and Panta® Nail XL) System. |
| ------------------------------------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|