(70 days)
No
The summary describes a knee implant and its mechanical properties, with no mention of AI or ML.
Yes
The device is a knee implant used for total knee replacement, which is a therapeutic intervention to treat conditions like osteoarthritis and rheumatoid arthritis.
No
The device is a total knee replacement system, which is a therapeutic device used in surgery, not a diagnostic device used to identify or characterize a disease.
No
The device description clearly describes physical femoral components for knee replacement surgery, which are hardware, not software.
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. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a femoral component, which is an implantable part of 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, etc.) to provide information for diagnosis, monitoring, or screening.
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 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.
Product codes
MBH, JWH
Device Description
One Logic femoral components are part of the Optetrak / Optetrak Logic device family and are for use in resurfacing femoral bone as part of tri-compartmental total knee arthroplasty employing modular components.
Cemented One Logic PS femoral components represent modifications to Optetrak Logic Total Knee System femoral components cleared per 510(k) submission K093360. Proposed cemented One Logic CR femoral components represent modifications to Optetrak Logic CR femoral components cleared per 510(k) submissions K111400 and K121307.
Porous-coated PS and CR One Logic femoral components represent modifications to porous PS and CR Optetrak Logic femoral components cleared per 510(k) submission K123687 and can be used in either press-fit or cemented applications.
One Logic femoral components operate using the same fundamental scientific technology, have the same intended use and Indications for Use statements, are offered in the same product size scopes, have the same device compatibility, and are implanted using the same instrumentation and surgical techniques as cited corresponding predicate Optetrak Logic femoral components.
One Logic femoral components are made from CoCr alloy. Like other femoral implants in the Optetrak / Optetrak Logic device family. One Logic femoral components are designed to articulate on an ultra-high molecular weight polyethylene tibial insert seated in a metal tibial tray.
One Logic CR and PS femoral components have the same basic features, boneapposing dimensions, articulating surface finish, and surface coating (where applicable) as predicate Optetrak Logic femoral components while providing surgeons with an option for comparatively streamlined and "softened" geometry, created by including slightly increased radii on the anterior aspect of the subject devices. The articulating congruence featured in all Optetrak and Optetrak Logic femoral-tibial condyle contact is maintained for One Logic femoral components. One Logic CR femoral components also feature a modified patella entry / exit point at the distal trochlear groove, intended to enhance patella transition.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
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 includes results for mechanical patellofemoral constraint testing.
Results of engineering studies referenced in this 510(k) submission demonstrate proposed One Logic devices are substantially equivalent to cited cleared predicate Optetrak Logic devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K093360, K111400, K121307, K123687
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
0
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 stylized depiction of three human profiles facing to the right, arranged in a way that they appear to be interconnected. The profiles are rendered in a simple, line-art style. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 10, 2016
Exactech Incorporated Mr. Patrick Hughes Senior Regulatory Affairs Specialist 2320 N.W. 66th Court Gainesville, Florida 32653
Re: K153776 Trade/Device Name: Optetrak One Logic Femoral Components Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: February 11, 2016 Received: February 12, 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K153776
Device Name
Optetrak One Logic Femoral Components
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K153776 - Page 1 of 3 Exactech® One Logic Femoral Components 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 11, 2016
Trade or Proprietary or Model Name(s):
Exactech® Optetrak® One Logic Femoral Components
Common Name: Cemented Total Knee Prosthesis
Classification Name:
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Product Code: MBH, JWH
Classification Panel: Orthopedic
Regulation Number 888.3565, 888.3560
Device Class II
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or Proprietary Model Name | Manufacturer | |
|---|---|---|---|
| K093360 | Optetrak Logic PS | ||
| K111400 | Optetrak Logic CR, Sizes 1-5 | Exactech, Inc | |
| K121307 | Optetrak Logic CR, Sizes 0 & 6 | ||
| K123687 | Optetrak Logic Porous Femoral Components |
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K153776 - Page 2 of 3 Exactech® One Logic Femoral Components 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:
One Logic femoral components are part of the Optetrak / Optetrak Logic device family and are for use in resurfacing femoral bone as part of tri-compartmental total knee arthroplasty employing modular components.
Cemented One Logic PS femoral components represent modifications to Optetrak Logic Total Knee System femoral components cleared per 510(k) submission K093360. Proposed cemented One Logic CR femoral components represent modifications to Optetrak Logic CR femoral components cleared per 510(k) submissions K111400 and K121307.
Porous-coated PS and CR One Logic femoral components represent modifications to porous PS and CR Optetrak Logic femoral components cleared per 510(k) submission K123687 and can be used in either press-fit or cemented applications.
One Logic femoral components operate using the same fundamental scientific technology, have the same intended use and Indications for Use statements, are offered in the same product size scopes, have the same device compatibility, and are implanted using the same instrumentation and surgical techniques as cited corresponding predicate Optetrak Logic femoral components.
Technological Characteristics
One Logic femoral components are made from CoCr alloy. Like other femoral implants in the Optetrak / Optetrak Logic device family. One Logic femoral components are designed to articulate on an ultra-high molecular weight polyethylene tibial insert seated in a metal tibial tray.
One Logic CR and PS femoral components have the same basic features, boneapposing dimensions, articulating surface finish, and surface coating (where applicable) as predicate Optetrak Logic femoral components while providing surgeons with an option for comparatively streamlined and "softened" geometry, created by including slightly increased radii on the anterior aspect of the subject devices. The articulating congruence featured in all Optetrak and Optetrak Logic femoral-tibial condyle contact is maintained for One Logic femoral components. One
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K153776 - Page 3 of 3 Exactech® One Logic Femoral Components Special 510(k) - 510(k) Summary of Safety and Effectiveness
Logic CR femoral components also feature a modified patella entry / exit point at the distal trochlear groove, intended to enhance patella transition.
Testing Description:
This submission includes results for mechanical patellofemoral constraint testing.
Substantial Equivalence Conclusion:
Results of engineering studies referenced in this 510(k) submission demonstrate proposed One Logic devices are substantially equivalent to cited cleared predicate Optetrak Logic devices.