(50 days)
No
The summary describes a mechanical implant (a tibial spacer) and its intended use and testing. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
Yes.
The device is a knee replacement system used to treat conditions like osteoarthritis and rheumatoid arthritis, which are considered therapeutic interventions.
No
The device description clearly states it is a titanium alloy spacer that assembles with other prostheses for total knee replacement, replacing joint space. This is a therapeutic device, not a diagnostic one.
No
The device description explicitly states the device is a "titanium alloy spacer," which is a physical hardware component, not software.
Based on the provided text, 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 implant, not a diagnostic test performed on biological samples in vitro.
- Device Description: The device is a titanium alloy spacer that is part of a knee prosthesis system. It is designed to be implanted in the body to replace a joint space.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions in vitro, or providing diagnostic information.
The device is a medical device intended for surgical implantation, not an in vitro diagnostic device.
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.
The OPTETRAK Comprehensive Knee Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, patients without sufficient soft tissue integrity to provide adequate stability, patients with either mental or neuromuscular disorders that do not allow control of the knee joint, and patients whose weight, age, or activity level might cause extreme loads and early failure of the system.
Product codes
JWH
Device Description
The proposed Exactech Optetrak® Proximal Tibial Spacer (PTS) is a titanium alloy spacer that assembles with the Optetrak® Tibial Tray and the Optetrak® Tibial Insert prostheses to replace the correct amount of joint space. This allows a combined tibial insert/tibial tray thickness comparable to the thickness provided by larger tibial inserts, while maintaining the function and performance of the predicate Optetrak Knee tibial insert/tibial tray assembly. The proposed Optetrak PTS is intended to take the place of inserts larger than 15mm by mating with the thinner inserts (ranging from 9mm to 15mm) to achieve the same total thickness.
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)
Mechanical tests and engineering analyses were conducted to demonstrate the safety and effectiveness of the Exactech Optetrak® PTS and support the claim of substantial equivalence to the predicates listed above.
Results from mechanical tests and engineering analyses provided within this 510(k) demonstrate that the Exactech Optetrak® PTS are substantially equivalent to the identified predicate devices. That is, the proposed device is as safe and effective and performs as well as or better than the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
#K932776/JWH, #K933610/JWH, #K936079/JWH, #K954208/JWH, #K011976/JWH, #K023186/JWH, #K033883/JWH
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
AUG 15 2007
3.2 377 - 40 FAX 3520178 2617
510(k) Summary
| Company: | Exactech, Inc |
|---|---|
| Establishment | |
| Registration: | 1038671 |
| Date: | June 25, 2007 |
| Contact Person: | Amnon Talmor, Regulatory Affairs Specialist |
| Proprietary Name: | Exactech Optetrak® Proximal Tibial Spacer |
| Common Name: | Tibial Knee Implant |
| Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer semi constrained |
| cemented prosthesis (21 CFR 888.3560, Class II, Product Code JWH) |
Legally Marketed Devices to Which Substantial Equivalence Is Claimed
| Device Name | 510(k)/Product
Code |
|--------------------------------------------------------------------------------------|------------------------|
| Exactech Cruciate Retaining Cemented Tibial Components | #K932776/JWH |
| Exactech Optetrak® Total Knee System Tibial Component | #K933610/JWH |
| Exactech Porous Coated Finned Tibial Tray Component | #K936079/JWH |
| Exactech Optetrak® Constrained Condylar Knee for Cemented Use | #K954208/JWH |
| Exactech Optetrak® Size 0 and 1 Delta Line Extension | #K011976/JWH |
| Exactech Optetrak® Total Knee System Offset Tibial Tray | #K023186/JWH |
| Optetrak® Total Knee System HI-FLEX Posterior-Stabilized Tibial Insert
Components | #K033883/JWH |
Device Description
The proposed Exactech Optetrak® Proximal Tibial Spacer (PTS) is a titanium alloy spacer that assembles with the Optetrak® Tibial Tray and the Optetrak® Tibial Insert prostheses to replace the correct amount of joint space. This allows a combined tibial insert/tibial tray thickness comparable to the thickness provided by larger tibial inserts, while maintaining the function and performance of the predicate Optetrak Knee tibial insert/tibial tray assembly. The proposed Optetrak PTS is intended to take the place of inserts larger than 15mm by mating with the thinner inserts (ranging from 9mm to 15mm) to achieve the same total thickness.
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.
The OPTETRAK Comprehensive Knee Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, patients without sufficient soft tissue integrity to provide adequate stability, patients with either mental or neuromuscular disorders that do not allow control of the knee joint, and patients whose weight, age, or activity level might cause extreme loads and early failure of the system.
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Image /page/1/Picture/0 description: The image shows the word "Exactech" in a bold, sans-serif font. The word is white and is set against a black background. To the left of the word is a stylized "e" symbol, also in white. A registered trademark symbol appears to the right of the word.
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Summary of Technological Characteristics
The rationale for substantial equivalence is based on consideration of the following characteristics.
- Intended Use. Exactech Optetrak® PTS and predicate devices are intended for use in total . knee joint replacement and have identical indications for use.
- Materials. Exactech Optetrak® PTS and predicate devices are composed of equivalent . materials conforming to recognized industry standards for permanent implants.
- Dimensions. Exactech Optetrak® PTS and predicate device components are available in . equivalent size ranges and have matching mating geometries
- Sterilization processes. Exactech Optetrak® PTS and predicate devices are sterilized using . equivalent sterilization processes conforming to recognized industry standards.
- Performance specifications. Exactech Optetrak® PTS and predicate devices conform to . recognized performance standards for total knee replacement devices. The performance specifications for the Exactech Optetrak® PTS are equivalent to the predicates.
Summary of Non-Clinical Performance Data
Mechanical tests and engineering analyses were conducted to demonstrate the safety and effectiveness of the Exactech Optetrak® PTS and support the claim of substantial equivalence to the predicates listed above.
Substantial Equivalence Conclusion
Results from mechanical tests and engineering analyses provided within this 510(k) demonstrate that the Exactech Optetrak® PTS are substantially equivalent to the identified predicate devices. That is, the proposed device is as safe and effective and performs as well as or better than the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three overlapping wing segments, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Exactech, Inc. % Mr. Amnon Talmor Regulatory Affairs Specialist 2320 N. W. 66th Ct. Gainesville, FL 32608
AUG 1 5 2007
Re: K071738
Trade/Device Name: Exactech Optetrak® Proximal Tibial Spacer Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Codes: JWH Dated: June 25, 2007 Received: June 26, 2007
Dear Mr. Talmor:
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 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.
3
Page 2 – Mr. Amnon Talmor
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin marketing your and equivalence of your device to a legally premarket notheadon: "The PDA mianing of basification 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 If you desire specific advice for Joan at (240) 276-0120. Also, please note the regulation entitled, Comact the Office of Complians an (21 t m =1 cart 807.97). You may obtain Milsonanding by reference to premantonitibilities under the Act from the Division of Small other general international and Consumer Assistance at toll-free number (800) 638-2041 or Manufacturers, International and Oosts http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
Barbave Buelup
Mark N. Melkerso Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
HFZ-401 DMC cc: HFZ-404 510(k) Staff HFZ- 410 DGRND
4
Exactech®, Inc.
Indications for Use
510(k) Number (if known):
Device Name: Exactech Optetrak Proximal Tibial Spacer
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.
The OPTETRAK Comprehensive Knee Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, patients without sufficient soft tissue integrity to provide adequate stability, patients with either mental or neuromuscular disorders that do not allow control of the knee joint, and patients whose weight, age, or activity level might cause extreme loads and early failure of the system.
Prescription Use and/or × (Part 21 CFR 801 Subpart D)
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)
Chubare Onelus
Division of General, Restorative, and Neurological Devices
510(k) Number K071736