(91 days)
No
The 510(k) summary describes a modification to existing knee implant components (thicker tibial inserts) and does not mention any AI or ML capabilities. The performance studies focus on mechanical properties like locking stability.
Yes.
The device is a knee implant used for total knee replacement, which is a therapeutic intervention for conditions like osteoarthritis and rheumatoid arthritis.
No
This device is a total knee replacement system, indicated for use in surgical procedures to replace a knee. It is an implantable medical device, not a diagnostic tool.
No
The device description clearly states it is a modification to physical tibial insert components made of UHMWPE, which are hardware.
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 due to various degenerative conditions. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical implant (tibial insert) used in knee arthroplasty.
- 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 treatment.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) as a replacement joint component.
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 System is indicated for cemented use only.
Product codes
JWH
Device Description
The proposed Optetrak Logic 17mm & 19mm Thick Inserts are modifications to Optetrak Logic ultra high molecular weight polyethylene (UHMWPE) tibial insert components cleared per 510(k)s K093360. K110547. K111400. K121307, and K123342.
This submission proposes adding 17mm and 19mm tibial insert options to the existing 9mm-15mm range of Optetrak Logic insert thicknesses. The 17mm and 19mm thick inserts will be provided across the current component size range (size 0 through size 6). Like the predicate devices, the proposed inserts are used in total knee arthroplasty (TKA) with metal femoral components and tibial trays. The thicker inserts are proposed for both posterior-stabilized (Logic PS, Logic PSC) and cruciate-retaining (Logic CR. Logic CRC) product options.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint
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)
Non-Clinical Performance Data:
Evaluation: Locking stability
Activity: Anterior/posterior liftoff/dissociation testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K093360, K110547, K111400, K121307, K123342, K933610, K932776
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
Exactech® Optetrak Logic® 17mm & 19mm Thick Inserts Traditional 510(k) - 510(k) Summary
Exactech, Inc. Sponsor: 2320 N.W. 66th Court Gainesville, FL 32653
Phone: (352) 327-4762 (352) 378-2617 Fax:
FDA Establishment Number 1038671
Contact: Patrick Hughes Senior Regulatory Affairs Specialist
Date: July 10. 2013
OCT 1 1 2013
Trade of Proprietary or Model Name(s): Exactech Optetrak Logic 17mm & 19mm Thick Inserts
Common Name:
Total Knee Arthroplasty - Tibial Inserts
Classification Name:
Cemented total knee prosthesis (CFR 888.3560, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Class II, Product Code JWH)
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| K093360 | Optetrak Logic PS | Exactech, Inc. |
| K110547 | Optetrak Logic PSC | Exactech, Inc. |
| K111400 | Optetrak Logic CR | Exactech, Inc. |
| K121307 | Optetrak Logic CR Sizes 0 & 6 | Exactech, Inc. |
| K123342 | Optetrak Logic CRC | Exactech, Inc. |
| K933610 | Exactech Cemented Total Knee System | |
| Tibial Components | Exactech, Inc. | |
| K932776 | Optetrak Cruciate Retaining Tibial | |
| Components | Exactech, Inc. |
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 System is indicated for cemented use only.
Page 1 of 2 Section 8
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K132161
Exactech® Optetrak Logic® 17mm & 19mm Thick Inserts Traditional 510(k) - 510(k) Summary
Device Description:
The proposed Optetrak Logic 17mm & 19mm Thick Inserts are modifications to Optetrak Logic ultra high molecular weight polyethylene (UHMWPE) tibial insert components cleared per 510(k)s K093360. K110547. K111400. K121307, and K123342.
This submission proposes adding 17mm and 19mm tibial insert options to the existing 9mm-15mm range of Optetrak Logic insert thicknesses. The 17mm and 19mm thick inserts will be provided across the current component size range (size 0 through size 6). Like the predicate devices, the proposed inserts are used in total knee arthroplasty (TKA) with metal femoral components and tibial trays. The thicker inserts are proposed for both posterior-stabilized (Logic PS, Logic PSC) and cruciate-retaining (Logic CR. Logic CRC) product options.
Comparison of Technological Characteristics
The predicate and proposed devices have the same intended use and basic fundamental scientific technology. The intended use of the modified device, as described in the labeling, has not changed as a result of the proposed modifications. The modified devices share the following similarities with the predicate devices:
- . Indications for use
- Design features (including mating geometry, locking mechanism, and . articulating geometry)
- . Material (UHMWPE per ASTM F648)
- o 8-year shelf life
- o Packaging and sterilization materials and processes (gamma radiation sterilization to a sterility assurance level of 10th
- . Use at the same site in the body for the same purpose (TKA)
The proposed components are not being submitted as the result of a recall or any corrective action related to the Optetrak product lines.
Non-Clinical Performance Data
Table 1 shows non-clinical performance data provided, cited, or referenced in this submission to support a conclusion of substantial equivalence:
Table 1: Optetrak Logic 17mm & 19mm Thick Tibial Inserts Testing
| Evaluation | Activity |
|---|---|
| Locking stability | Anterior/posterior liftoff/dissociation testing |
Substantial Equivalence Conclusion:
Comparison analysis and results of engineering studies referenced in this 510(k) submission demonstrate proposed Optetrak Logic 17mm Thick Tibial Inserts are substantially equivalent to predicate Optetrak Logic tibial inserts cleared per 510(k)s K093360, K110547, K111400, K121307. K123342, K933610, and K932776.
Page 2 of 2 Section 8
2
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
October 11, 2013
Exactech, Incorporated Mr. Patrick Hughes Senior Regulatory Affairs Specialist 2320 North West 66th Court Gainesville, Florida 32653
Re: K132161
Trade/Device Name: Exactech® Optetrak Logic® 17mm & 19mm Thick Inserts 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: September 19, 2013 Received: September 20, 2013
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 Part 801); medical device reporting (reporting of medical
3
Page 2 - Mr. Patrick Hughes
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers. International and Consumer Assistance 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.
Sincercly yours.
Erin Keith
िर
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Exactech® Optetrak Logic® 17mm & 19mm Thick Inserts Special 510(k) - Indications for Use
510(k) Number: K132161
Device Name: Exactech® Optetrak Logic® 17mm & 19mm Thick Inserts
INDICATIONS
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 System is indicated for cemented use only.
Prescription Use_ ど (Part 21 CFR 801 Subpart D) and/or
Over-The-Counter Use (21 CFR 807 Subpart C)
Please do not write below this line - use another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
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