(48 days)
Not Found
No
The summary describes a mechanical implant (tibial insert) with a specific geometric modification (+6° posterior angle) and does not mention any computational or algorithmic components, let alone AI/ML.
Yes
Explanation: The device is an integral part of a total knee replacement system, which is a therapeutic intervention for various knee conditions.
No
The device is a knee implant used for total knee replacement, not a tool for diagnosing medical conditions. It is a therapy device.
No
The device description clearly states it is a physical implant (tibial inserts made of polyethylene) and not a software-only device.
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 description clearly states that the device is a "ultra high molecular weight polyethylene tibial insert" intended for surgical implantation in the knee.
- Intended Use: The intended use is for "primary surgery for total knee replacement" and "revision of failed previous reconstructions." This is a surgical procedure, not a diagnostic test performed on a sample.
The device is a surgical implant used during a procedure, not a test performed on a sample to diagnose something.
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.
Product codes
JWH
Device Description
The proposed Optetrak CR Slope 9mm ++ devices are ultra high molecular weight polyethylene tibial inserts intended to enable surgeons to adjust tibial slope, and therefore PCL function, at the end of a procedure without the need for additional bone cuts. The proposed devices are made from the same materials as the predicated devices. There the also compatible with the same femoral, tibial and patellar components as the cleared predicate devices. The only difference between devices is a +6° posterior angle built into the Optetrak CR Slope 9mm ++ tibial inserts.
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)
Engineering evaluations were conducted to verify that the performance of the proposed components would be adequate for anticipated in vivo use. Based on successful results discussed in this submission, we conclude that the proposed devices are substantially equivalent to the previously cleared predicates.
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
Exactech® Optetrak® 9mm Cruciate Retaining Tibial Insert Slope ++ Special 510(k) - Summary of Safety and Effectiveness
Sponsor: Exactech® Inc. 2320 N.W. 66th Court Gainesville, Florida 32653
SEP - 2 2008
Phone: (352) - 377 - 1140 Fax: (352) - 378 - 2617
FDA Establishment Number 1038671
Contact: Graham Cuthbert Regulatory Representative
Date: June 25, 2008
1
Exactech® Optetrak® 9mm Cruciate Retaining Tibial Insert Slope ++ Special 510(k) - Summary of Safety and Effectiveness
Trade or proprietary or model name(s):
Exactech® Optetrak® 9mm Cruciate Retaining Tibial Insert Slope ++
Common Name
Cruciate Retaining Tibial Insert
Classification name
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal polymer (21 CFR Section 888.3560)
Information on devices to which substantial equivalence is claimed:
| 510(k)
| Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| K932690 | Optetrak® Cruciate Retaining Cemented Total Knee | |
| System | 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.
Device Description:
The proposed Optetrak CR Slope 9mm ++ devices are ultra high molecular weight polyethylene tibial inserts intended to enable surgeons to adjust tibial slope, and therefore PCL function, at the end of a procedure without the need for additional bone cuts. The proposed devices are made from the same materials as the predicated devices. There the also compatible with the same femoral, tibial and patellar components as the cleared predicate devices. The only difference between devices is a +6° posterior angle built into the Optetrak CR Slope 9mm ++ tibial inserts.
Substantial Equivalency Conclusion:
Engineering evaluations were conducted to verify that the performance of the proposed components would be adequate for anticipated in vivo use. Based on successful results discussed in this submission, we conclude that the proposed devices are substantially equivalent to the previously cleared predicates.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three overlapping, curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 2 2008
Exactech. Inc. % Mr. Graham Cuthbert Regulatory Representative 2320 N.W. 66th Court Gainesville, Florida 32653
Re: K082022
Trade/Device Name: Exactech Optetrak® 9 mm Cruciate Retaining Tibial Insert Slope ++ 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: August 20, 2008 Received: August 21, 2008
Dear Mr. Cuthbert:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
3
Page 2 - Mr. Graham Cuthbert
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark H. Millman
Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Exactech® Optetrak® 9mm Cruciate Retaining Tibial Insert Slope ++ Special 510(k) - Indications for Use
K082022 510(k) Number:
Device Name: Exactech® Optetrak® 9mm Cruciate Retaining Tibial Insert Slope ++
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.
Prescription Use X and/or Over-The-Counter Use _ (Part 21 CFR 801 Subpart D) (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)
Soubau Buemo
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K082022