(25 days)
No
The summary describes a mechanical knee implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a total knee replacement system, which is used to treat medical conditions like osteoarthritis, osteonecrosis, and rheumatoid arthritis, thereby restoring function and alleviating pain in the knee joint.
No
The device is a total knee replacement system, which is used for treatment (surgical implantation), not for diagnosing conditions.
No
The device description clearly states it is an "implant" and discusses "dimensional modifications" and "bone coverage," indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for total knee replacement surgery in skeletally mature individuals with specific knee conditions. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is an implantable component (patella implant) for a knee replacement system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The OPTETRAK Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. In the USA, the OPTETRAK Comprehensive Knee Systems are indicated for cemented use only, except for the OPTETRAK Logic PS and CR Porous Femoral Components, which are indicated for cemented or cementless use.
Product codes
JWH
Device Description
Optetrak Advanced Patella implants represent dimensional modifications to "classic" Optetrak patella components. Like the predicate devices, Optetrak Advanced Patella implants are intended for resurfacing the patella during tri-compartmental total knee arthroplasty with other Optetrak and Optetrak Logic components. Optetrak Advanced Patella implants are designed to provide expanded options to help surgeons optimize bone coverage while keeping the same basic features and device compatibility as predicate "classic" Optetrak patella implants.
The Optetrak Advanced Patella is an orthopedic implant made from ultra-high molecular weight polyethylene. It features the same spherical articulating geometry, mating device congruence, and bone-apposing fixation features as other Optetrak patella implants, and is provided in a similar product scope. Where other Optetrak patella components are circular, the Optetrak Advanced Patella features an increase in medial-lateral area relative to the proximal-distal aspect on the bone-apposing face of the implant and an asymmetric, "avocado"-shaped perimeter. Like other Optetrak patella implants, the Optetrak Advanced Patella is intended for cemented fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee, patella
Indicated Patient Age Range
Skeletally mature individuals
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)
This submission reports results for the following mechanical testing:
- o Patellofemoral contact pressure analysis
Reported results show the Optetrak Advanced Patella Devices do not represent a new worst-case
Results of engineering studies referenced in this 510(k) submission demonstrate proposed Optetrak Advanced Patella devices are substantially equivalent to cited cleared predicate Optetrak patella components.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol depicts a stylized human figure with three faces in profile, representing the department's focus on health and human well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 18, 2016
Exactech Incorporated Mr. Patrick Hughes Senior Regulatory Affairs Specialist 2320 Northwest 66th Court Gainesville, Florida 32653
Re: K160484 Trade/Device Name: Optetrak Advanced Patella Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: February 17, 2016 Received: February 22, 2016
Dear Mr. Hughes:
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, 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) 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" (21CFR 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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160484
Device Name Optetrak Advanced Patella
Indications for Use (Describe)
The OPTETRAK Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, theumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revious reconstructions where sufficient bone stock and soft tissue integrity are present. In the USA, the OPTETRAK Comprehensive Knee Systems are indicated for cemented use only, except for the OPTETRAK Logic PS and CR Porous Femoral Components, which are indicated for cemented or cementless use.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
Exactech® Optetrak® Advanced Patella Special 510(k) - 510(k) Summary of Safety and Effectiveness
| Sponsor: | Exactech, Inc.
2320 N.W. 66th Court
Gainesville, FL 32653 |
|----------|-----------------------------------------------------------------|
| | Phone: (352) 377-1140
Fax: (352) 378-2617 |
| | FDA Establishment Number 1038671 |
| Contact: | Patrick Hughes
Senior Regulatory Affairs Specialist |
| Date: | February 18, 2016 |
Trade or Proprietary or Model Name(s):
Exactech® Optetrak® Advanced Patella
Common Name: Cemented Total Knee Prosthesis
Classification Name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Classification Panel: Orthopedic
Product Code: JWH
Regulation Number 888.3560
Device Class II
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or Proprietary Model Name | Manufacturer |
|---|---|---|
| K954208 | Optetrak Constrained Condylar Knee | Exactech, Inc |
4
Exactech® Optetrak® Advanced Patella Special 510(k) - 510(k) Summary of Safety and Effectiveness
Indications for Use:
The OPTETRAK Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. In the USA, the OPTETRAK Comprehensive Knee Systems are indicated for cemented use only, except for the OPTETRAK Logic PS and CR Porous Femoral Components, which are indicated for cemented or cementless use.
Device Description:
Optetrak Advanced Patella implants represent dimensional modifications to "classic" Optetrak patella components. Like the predicate devices, Optetrak Advanced Patella implants are intended for resurfacing the patella during tri-compartmental total knee arthroplasty with other Optetrak and Optetrak Logic components. Optetrak Advanced Patella implants are designed to provide expanded options to help surgeons optimize bone coverage while keeping the same basic features and device compatibility as predicate "classic" Optetrak patella implants.
Technological Characteristics
The Optetrak Advanced Patella is an orthopedic implant made from ultra-high molecular weight polyethylene. It features the same spherical articulating geometry, mating device congruence, and bone-apposing fixation features as other Optetrak patella implants, and is provided in a similar product scope. Where other Optetrak patella components are circular, the Optetrak Advanced Patella features an increase in medial-lateral area relative to the proximal-distal aspect on the bone-apposing face of the implant and an asymmetric, "avocado"-shaped perimeter. Like other Optetrak patella implants, the Optetrak Advanced Patella is intended for cemented fixation.
Testing Description:
This submission reports results for the following mechanical testing:
- o Patellofemoral contact pressure analysis
Reported results show the Optetrak Advanced Patella Devices do not represent a new worst-case
Substantial Equivalence Conclusion:
Results of engineering studies referenced in this 510(k) submission demonstrate proposed Optetrak Advanced Patella devices are substantially equivalent to cited cleared predicate Optetrak patella components.