(145 days)
INBONE Total Ankle System (K193067)
No
The document describes a mechanical implant for ankle replacement and does not mention any AI/ML components or capabilities.
Yes
The device is a total ankle replacement system used to treat damaged ankle joints due to severe arthritis, which aligns with the definition of a therapeutic device.
No
The device description and intended use clearly state that the APEX 3D Total Ankle Replacement System is used for ankle joint replacement in primary and revision surgery for patients with damaged ankle joints, which is a therapeutic purpose. There is no mention of the device being used to diagnose a condition or disease.
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:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The APEX 3D Total Ankle Replacement System is a physical implant designed to replace a damaged ankle joint. It is surgically implanted into the patient's body.
- Intended Use: The intended use is to replace a damaged ankle joint due to arthritis, not to perform diagnostic tests on bodily samples.
The information provided clearly describes a surgical implant, not a diagnostic test.
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. In the United States, components are intended for cemented use only.
Product codes
HSN
Device Description
The APEX 3D Total Ankle Replacement System 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
All necessary testing has been performed on representative APEX 3D Total Ankle Replacement components to assure substantial equivalence to its predicate and demonstrate the subject device performs as intended. All testing was performed on finished devices. Non-clinical testing included:
- Cantilever Fatigue
- Porous Structure Characterization
- Porous Structure Tensile, Static Shear, Fatigue Shear, Abrasion
- Tibial Stem Stability (Micromotion)
- Shear Strength of Stem
- Residual Powder
- 3D Printing Process Validation
- Image Artifact
- Magnetically Induced Displacement Force
- Magnetically Induced Torque
- Radiofrequency (RF) Induced Heating
Clinical data are not needed to support the safety and effectiveness of the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Paragon 28 APEX 3D Total Ankle Replacement System (K192994)
Reference Device(s)
INBONE Total Ankle System (K193067)
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
Image /page/0/Picture/0 description: The image shows 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.
June 24, 2024
Paragon 28, Inc. Haylie Fast Associate Manager of Regulatory Affairs 14445 Grasslands Drive Englewood, Colorado 80112
Re: K240259
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 16, 2024 Received: February 16, 2024
Dear Haylie Fast:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Lixin Liu -S
Lixin Liu, PhD 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
2
Indications for Use
Submission Number (if known)
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. In the United States, components are intended for cemented use only.
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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3
510(K) SUMMARY
| 510(k) Number: | K240259 |
|---|---|
| Manufacturer: | Paragon 28, Inc. |
| 14445 Grasslands Dr. | |
| Englewood, CO 80112 | |
| Contact: | Haylie Fast |
| Manager of Regulatory Affairs | |
| Paragon 28, Inc. | |
| 14445 Grasslands Dr. | |
| Englewood, CO 80112 | |
| Phone: 720-994-5489 | |
| hfast@paragon28.com | |
| Date Prepared: | June 21st, 2024 |
| Device Trade Name: | APEX 3D Total Ankle Replacement System |
| Device Class and | |
| Common Name: | Class II, Total Ankle Prosthesis |
| Classification: | 21 CFR 888.3110: Ankle Joint Metal/Polymer Semi-Constrained |
| Cemented Prosthesis | |
| 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. In the United States, | |
| components are intended for cemented use only. | |
| Device Description: | The APEX 3D Total Ankle Replacement System 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
Primary Predicate: Paragon 28 APEX 3D Total Ankle Replacement System (K192994)
Reference Device: INBONE Total Ankle System (K193067)
The APEX 3D Total Ankle Replacement System is substantially Substantial equivalent to the legally marketed predicate device systems with Equivalence: respect to intended use and design. The subject Short Stem Tibia implant is identical to the cleared APEX 3D Tibial Trays in terms of material, shape, and dimensions of the tray. The way the implants differ is the anterior fixation feature. The subject device proposes a central stem, the predicate device has two pegs. The MR Conditional labeling is also updated.
The differences in technological characteristics between the subject device and predicate device were shown not to introduce different questions of safety and effectiveness.
Performance Testing: All necessary testing has been performed on representative APEX 3D Total Ankle Replacement components to assure substantial equivalence to its predicate and demonstrate the subject device performs as intended. All testing was performed on finished devices. Non-clinical testing included:
- Cantilever Fatigue
- Porous Structure Characterization
- Porous Structure Tensile, Static Shear, Fatigue Shear, Abrasion
- Tibial Stem Stability (Micromotion)
- Shear Strength of Stem
- Residual Powder
- 3D Printing Process Validation
- Image Artifact
- Magnetically Induced Displacement Force
- Magnetically Induced Torque
- Radiofrequency (RF) Induced Heating
Clinical data are not needed to support the safety and effectiveness of the subject device.
- Conclusions: The APEX 3D Total Ankle Replacement System subject to this submission possesses the same intended use and has similar technological characteristics as the predicate device system components. The performance testing demonstrates that the APEX 3D Total Ankle Replacement System is as safe and effective as the predicate device.