K Number
K210390
Device Name
Apex 3D Total Ankle Replacement System
Manufacturer
Date Cleared
2021-03-06

(25 days)

Product Code
Regulation Number
888.3110
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
More Information

No
The summary describes a mechanical implant for ankle replacement and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.

Yes
The device is indicated for use as a total ankle replacement to treat damaged ankle joints, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.

No
The device description and intended use indicate that the device is a total ankle replacement system for surgical implantation, not a diagnostic tool used to identify or analyze a condition.

No

The device description clearly 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:

  • Intended Use: The intended use clearly states it's a "total ankle replacement" for patients with damaged ankle joints due to arthritis. This is a surgical implant, not a test performed on samples from the body to diagnose a condition.
  • Device Description: The description details the components of a surgical implant (tibial component, talar component, UHMWPE component) used for "ankle joint replacement."
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Detecting or measuring substances in those samples
    • Providing information for diagnosis, monitoring, or screening

This device is a surgical implant used to replace a damaged joint.

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 rheumatoid, post-traumatic, 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 joint

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

Engineering analysis is presented to provide evidence that the original testing and subsequent performance is not adversely affected by the modifications to the subject devices. This included a talar stability assessment and bacterial endotoxin testing. The results of the analysis demonstrated the modified designs are substantially equivalent to the predicate device.

Key Metrics

Not Found

Predicate Device(s)

APEX 3D Total Ankle Replacement System (K192994)

Reference Device(s)

Agility Ankle Revision Prosthesis (K020541)

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

March 6, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Paragon 28, Inc. Haylie Hertz Regulatory Affairs Specialist 14445 Grasslands Dr. Englewood, Colorado 80112

Re: K210390

Trade/Device Name: 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: February 5, 2021 Received: February 9, 2021

Dear Haylie Hertz:

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 medical devices and radiation-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. 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)

K210390

Device Name 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 rheumatoid, post-traumatic, 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)
X Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)

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3

510(k) Summary

510(k) Number:K210390
Device Trade Name:APEX 3D Total Ankle Replacement System
Manufacturer:Paragon 28, Inc.
14445 Grasslands Dr.
Englewood, CO 80112
Contact:Ms. Haylie Hertz
Regulatory Affairs Specialist
Phone: 303.720.0017
hhertz@paragon28.com
Date Prepared:March 1, 2021
Classification:21 CFR §888.3110; Ankle joint metal/polymer semi-
constrained cemented prosthesis
Class:II
Product Code:HSN
Common Name:Total Ankle Replacement
Predicate Device:APEX 3D Total Ankle Replacement System (K192994)
Reference Device:Agility Ankle Revision Prosthesis (K020541)

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.

Substantial Equivalence:

The subject APEX 3D Total Ankle Replacement System and the predicate system are intended to be used in total ankle arthroplasty procedures. The indications for the subject device are identical to the indications of the predicate device.

4

The subject APEX 3D Total Ankle Replacement components possess the same technological characteristics as the predicate device. These include:

  • . performance,
  • basic design, ●
  • material, manufacturing and
  • sizes (dimensions are comparable to those offered by the predicate systems).

Differences between the APEX 3D Total Ankle Replacement implants and the predicate devices (TPS coating) were shown not to raise new questions of safety and effectiveness. Therefore, the fundamental scientific technology of the subject APEX 3D Total Ankle Replacement System components is similar to previously cleared device.

Performance Data:

Engineering analysis is presented to provide evidence that the original testing and subsequent performance is not adversely affected by the modifications to the subject devices. This included a talar stability assessment and bacterial endotoxin testing.

The results of the analysis demonstrated the modified designs are substantially equivalent to the predicate device.

Conclusion:

The modified APEX 3D Total Ankle Replacement System possesses the same indications for use and technological characteristics as the predicate APEX 3D Total Ankle Replacement System (K192994). Therefore, the APEX 3D Total Ankle Replacement System is substantially equivalent to the predicate device with respect to indications for use, technical characteristics, and function