(149 days)
Not Found
No
The document describes a mechanical knee implant and its components, focusing on materials, design modifications, and intended use. There is no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is a total knee replacement system intended to treat conditions like osteoarthritis and rheumatoid arthritis, which are medical conditions that cause pain and functional impairment, thus it provides a therapeutic benefit.
No
This device is a total knee replacement system, intended for use as a prosthesis to replace a damaged knee joint, not to diagnose a condition.
No
The device description explicitly details physical components made of Cobalt Chrome and Ti-6Al-4V, which are hardware materials used in knee implants. The intended use also describes a total knee replacement, which is a physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Apex Knee™ System is for "primary or revision total knee replacement." This is a surgical procedure involving the implantation of a medical device into the body.
- Device Description: The device description details the components of a knee prosthesis (femoral component, tibial baseplate, patellar components, augments, bolts) and their materials. These are physical implants.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests.
The information provided describes a surgically implanted medical device used to replace a damaged knee joint, which falls under the category of orthopedic implants, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Apex Knee™ System is intended for use as a primary or revision total knee replacement. This prosthesis may be used for the following conditions, as appropriate:
- · Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- · Rheumatoid arthritis;
- · Correction of functional deformity;
- · Revision procedures where other treatments or devices have failed;
The porous coated femoral component may be used cemented (biological fixation). The porous coated tibial baseplate component may be used uncemented (biological fixation). All other femoral, tibial baseplate and patellar components are indicated for cemented use only.
The Apex Knee™ Modular Tibial Augments are intended to the Tibia Baseplate and cemented to the prepared tibia. The Apex Revision Knee system augments are intended to the femoral component and cemented to the prepared femur.
Product codes
JWH
Device Description
The proposed devices are intended to be used for primary and revision total knee replacement.
The Revision Tibia Baseplates offer enhanced torsional stability by adding keels to the posterior end of the device. This design is similar to keeled stem designs currently marketed.
The retaining bolt modifications offer additional bolt sizes that allow the cleared tibial inserts to lock into the proposed longer Revision tibial Baseplate.
The material of the proposed Revision Tibial Baseplate is Cobalt Chrome, CoCr (ASTM F75). The material if the proposed retaining bolts is Ti-6Al-4V E.L.I (ASTM F136)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Knee
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was not conducted but the devices were evaluated and no-testing justifications were written. The following justifications were written to explain the safety and effectiveness of the revision knee with the proposed modifications: KTR-116 Tray Fatigue FEA. The modifications do not raise any new safety or effectiveness concerns.
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
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized human figure, with three faces in profile overlapping each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 26, 2017
OMNIlife Science Ms. Christina Rovaldi Regulatory Affairs Specialist 480 Paramount Drive Raynham, Massachusetts 02767
Re: K163332
Trade/Device Name: Apex Revision Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: March 27, 2017 Received: March 28, 2017
Dear Ms. Rovaldi:
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. The general controls provisions of the Act include requirements for annual registration. Isting 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K163332
Device Name Apex Revision Knee System
Indications for Use (Describe)
The Apex Knee™ System is intended for use as a primary or revision total knee replacement. This prosthesis may be used for the following conditions, as appropriate:
- · Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
- · Rheumatoid arthritis;
- · Correction of functional deformity;
- · Revision procedures where other treatments or devices have failed;
The porous coated femoral component may be used cemented (biological fixation). The porous coated tibial baseplate component may be used uncemented (biological fixation). All other femoral, tibial baseplate and patellar components are indicated for cemented use only.
The Apex Knee™ Modular Tibial Augments are intended to the Tibia Baseplate and cemented to the prepared tibia. The Apex Revision Knee system augments are intended to the femoral component and cemented to the prepared femur.
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
| TABLE 1: 510(k) SUMMARY | |
|---|---|
| Date Summary Prepared | 11/23/2016 |
| Manufacturer/Distributor/Sponsor | OMNIlife Science, Inc. |
| 480 Paramount Drive | |
| Raynham MA 02767 | |
| 510(k) Contact | Christina Rovaldi |
| Regulatory Affairs Specialist | |
| OMNIlife Science | |
| 480 Paramount Drive | |
| Raynham MA 02767 | |
| Telephone: 774-226-1857 | |
| Fax: 508-822-6030 | |
| Email: crovaldi@omnils.com | |
| Trade Name | Apex Revision Knee System |
| Common Name | Knee joint patellofemorotibial polymer/metal/polymer |
| semi-constrained cemented prosthesis | |
| Classification | 21 CFR 888.3560 Prosthesis, Knee, |
| Patellofemorotibial, Semi-Constrained, Cemented, | |
| Polymer/Metal/Polymer | |
| JWH | |
| Predicate Device | K153437 Apex Revision Knee System, |
| Purpose of Submission | This Special 510(k) premarket notification is being |
| submitted to propose modifications to the Apex Knee | |
| Revision System (K153437) by adding additional | |
| baseplate and retaining bolt types to expand the product | |
| offering. | |
| Intended Use | The Apex Knee™ System is intended for use as a |
| primary or revision total knee replacement. This | |
| prosthesis may be used for the following conditions, as | |
| appropriate: | |
| • Non-inflammatory degenerative joint disease, | |
| including osteoarthritis and avascular necrosis; | |
| Rheumatoid arthritis; Correction of functional deformity; Revision procedures where other treatments or devices have failed; The porous coated femoral component may be used cemented or uncemented (biological fixation). The porous coated tibial baseplate component may be used uncemented (biological fixation). All other femoral, tibial baseplate and patellar components are indicated for cemented use only. | |
| The Apex Knee™ Modular Tibial Augments are intended to be bolted to the Tibia Baseplate and cemented to the prepared tibia. The Apex Revision Knee system augments are intended to be bolted to the femoral component and cemented to the prepared femur. | |
| Device Description | The proposed devices are intended to be used for primary and revision total knee replacement. |
| The Revision Tibia Baseplates offer enhanced torsional stability by adding keels to the posterior end of the device. This design is similar to keeled stem designs currently marketed. | |
| The retaining bolt modifications offer additional bolt sizes that allow the cleared tibial inserts to lock into the proposed longer Revision tibial Baseplate. | |
| The material of the proposed Revision Tibial Baseplate is Cobalt Chrome, CoCr (ASTM F75). The material if the proposed retaining bolts is Ti-6Al-4V E.L.I (ASTM F136) | |
| Substantial Equivalence Summary | The proposed devices with modifications are substantially equivalent to the existing Apex Revision Knee System cleared in K153437 as the basic design, interface, fundamental technology, materials and intended use are the same. |
| The use of the new Revision Knee System components | |
| with the existing revision knee components do not | |
| introduce any new risks of safety or efficacy. | |
| Testing was not conducted but the devices were | |
| evaluated and no-testing justifications were written. | |
| The following justifications were written to explain the | |
| safety and effectiveness of the revision knee with the | |
| proposed modifications. The modifications do not raise | |
| any new safety or effectiveness concerns. | |
| - KTR-116 Tray Fatigue FEA | |
| The justifications are described in section 12, Device | |
| Description. | |
| Based on the design, fundamental technology, identical | |
| material, intended use and technological | |
| characteristics, OMNIlife science believes the proposed | |
| Apex Revision Knee System devices to be substantially | |
| equivalent to legally marketed predicates. | |
| Conclusion Statement | The conclusions drawn from the nonclinical tests |
| demonstrate that the devices are as safe, as effective, | |
| and performs as well as or better than the legally |
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