(259 days)
No
The summary describes a mechanical implant and does not mention any AI/ML components or functionalities.
Yes
Explanation: The device is a total ankle replacement system indicated for treating severe arthritis in the ankle joint, which is a therapeutic intervention aimed at restoring function and alleviating symptoms.
No
The device is an ankle replacement system, which is a prosthetic device used for treatment (replacement), not diagnosis.
No
The device description explicitly states it is comprised of physical components (tibial component, talar component, and UHMWPE component) used for ankle joint replacement, indicating it is a hardware device, not software-only.
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, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the APEX 3D Total Ankle Replacement System is a surgical implant used to replace a damaged ankle joint. It is a physical device inserted into the body.
- Lack of IVD Characteristics: The provided information does not mention any analysis of biological specimens, laboratory testing, or diagnostic purposes.
Therefore, based on the provided information, the APEX 3D Total Ankle Replacement System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The APEX 3D Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. Components are intended use only.
Product codes
HSN
Device Description
The Paragon 28 APEX 3D Total Ankle Replacement device is a cemented, fixed-bearing device comprised of a tibial component, a talar component, and a UHMWPE component used for ankle joint replacement. Based on patient anatomy, a number of component sizes and design configurations can be selected for best fit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle 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
Performance data for the Paragon 28 APEX 3D Total Ankle Replacement System demonstrate its substantial equivalence to the INVISION Total Ankle Revision System (K171067), Salto XT, Salto Talaris (K153452) and the Integra Cadence Total Ankle System (K151459). Testing performed on the subject devices includes:
- Range of Motion
- Contact Stress and Contact Area
- Constraint
- Disassembly Strength of the Tibial Tray and Insert
- Cantilever Fatigue Strength of Tibial Tray
- Polyethylene Wear
- Porous Structure Characterization
- Pyrogenicity (LAL) Testing
Each of these studies were designed to address risks and demonstrate substantially equivalent performance to predicate devices.
Non-clinical testing performed included range of motion, contact stress and contact area analysis, constraint characteristic testing, testing, polyethylene wear testing, fatigue disassembly testing. material characterization, and user validation. The results of this testing demonstrate that the subject system performs as intended with results exceeding anticipated physiologic loads. Additionally, the Paragon 28 APEX 3D Total Ankle Replacement System is in compliance with LAL testing requirements for orthopedic implants.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
July 10, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with an eagle and text around it. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION". The logo is simple and professional, and it is easily recognizable.
Paragon 28, Inc. % Hollace Rhodes Vice President, Regulatory Affairs MCRA, LLC 1050 K Street NW. Suite 1000 Washington, District of Columbia 20001
Re: K192994
Trade/Device Name: Paragon 28 APEX 3D Total Ankle Replacement System Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSN Dated: June 19, 2020 Received: June 19, 2020
Dear Hollace Rhodes:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Ting Song, Ph.D., R.A.C. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Paragon 28 APEX 3D Total Ankle Replacement System
Indications for Use (Describe)
The APEX 3D Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. Components are intended use only.
Type of Use (Select one or both, as applicable)
| Representational Use (21 CFR 321.1 Subject to Premarket Review) |
|---|
| OTC Therapeutic Use (21 CFR 321.1) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| Manufacturer: | Paragon 28, Inc.
14445 Grasslands Drive
Englewood, CO 80112 |
|---------------------|------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. Eric Lintula
Senior Director of Quality and Regulatory Affairs
Phone: 855-786-2828
elintula@paragon28.com |
| Prepared By: | MCRA, LLC
1050 K Street, NW, Suite 1000
Washington, DC 20001
Phone: 202.552.5800 |
| Date Prepared: | November 20, 2019 |
| Device Trade Name: | Paragon 28 APEX 3D Total Ankle Replacement System |
| Device Common Name: | Total Ankle Prosthesis |
| Classification: | 21 CFR 888.3110, Ankle joint metal/polymer semi-constrained
cemented prosthesis
Class II |
| Product Code: | HSN |
Indications for Use:
The APEX 3D Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. Components are intended for cemented use only.
Device Description:
The Paragon 28 APEX 3D Total Ankle Replacement device is a cemented, fixed-bearing device comprised of a tibial component, a talar component, and a UHMWPE component used for ankle joint replacement. Based on patient anatomy, a number of component sizes and design configurations can be selected for best fit.
4
Performance Testing Summary:
Performance data for the Paragon 28 APEX 3D Total Ankle Replacement System demonstrate its substantial equivalence to the INVISION Total Ankle Revision System (K171067), Salto XT, Salto Talaris (K153452) and the Integra Cadence Total Ankle System (K151459). Testing performed on the subject devices includes:
- Range of Motion
- Contact Stress and Contact Area
- Constraint ●
- Disassembly Strength of the Tibial Tray and Insert ●
- Cantilever Fatigue Strength of Tibial Tray ●
- Polyethylene Wear
- . Porous Structure Characterization
- Pyrogenicity (LAL) Testing
Each of these studies were designed to address risks and demonstrate substantially equivale nt performance to predicate devices.
Predicate Devices:
The Paragon 28 APEX 3D Total Ankle Replacement System is substantially equivalent to the INVISION Total Ankle Revision System (K171067), Salto Talaris (K153452) and the Integra Cadence Total Ankle System (K151459).
Substantial Equivalence:
The subject system is substantially equivalent to the predicate systems with respect to intended use, indications, design, materials and available size range. Non-clinical testing performed included range of motion, contact stress and contact area analysis, constraint characteristic testing, testing, polyethylene wear testing, fatigue disassembly testing. material characterization, and user validation. The results of this testing demonstrate that the subject system performs as intended with results exceeding anticipated physiologic loads. Additionally, the Paragon 28 APEX 3D Total Ankle Replacement System is in compliance with LAL testing requirements for orthopedic implants.
Conclusion:
The nonclinical testing demonstrates that the Paragon 28 APEX 3D Total Ankle Replacement System is as safe, as effective, and perform as well as or better than the predicate devices.