(60 days)
No
The summary describes changes to the physical geometry of existing knee replacement components and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a knee implant intended to replace parts of the patient's knee during total knee arthroplasty, which is a medical procedure to treat conditions like osteoarthritis and post-traumatic degenerative problems. This fits the definition of a therapeutic device as it is used to treat or alleviate a medical condition.
No
The device is a knee implant (femoral components and tibial inserts) used for total knee arthroplasty, not for diagnosing conditions.
No
The device description clearly states that the device is a combination of femoral and tibial insert components, which are physical implants used in total knee arthroplasty. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "replace the patient's distal femur and proximal tibia during primary or revision total knee arthroplasty." This is a surgical implant, not a device used to examine specimens derived from the human body.
- Device Description: The description details the physical components of a knee replacement system (femoral components and tibial inserts).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Optetrak® HI-FLEX Asymmetric Posterior-Stabilized Cemented Femoral Components (herein referred to as the Optetrak® HI-FLEX PS Femoral Components) and Optetrak® HI-FLEX Posterior-Stabilized Tibial Inscrts (Herein referred to as the HI-FLEX PS Tibial Inserts) are intended to be used with an Optetrak® Tibial Tray to replace the patient's distal fomur and proximal tibia during primary or revision total knee arthroplasty. The Optetrak® HI-FLEX PS Femoral components are intended for use when needed to closely match the geometry of the patient's resected distal femur and allows for more flexion than the standard Optetrak® components.
The Optetrak® HI-FLEX PS Tibial Insert is intended for use with the Optetrak® HI-FLEX PS Femoral components to afford the patient a higher degree of flexion than the standard Optetrak " femoral/tibial insert combination.
The proposed components are intended for use in total knee arthroplasty procedures in which the Posterior Cruciate Ligament (PCL) must be sacrificed.
All proposed femoral components are intended for cemented use only.
INDICATIONS
The OPTETRAK® Total Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knce replacement due to osteoarthritis, osteonecrosis, theurnatoid 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.
CONTRAINDICATIONS
The OPTETRAK® Total Knee Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate inscrtion and fixation of the prosthesis, patients without sufficient soft tissue integrity to provide adequate stability, and in patients with either mental or neuromuscular disorders that don't allow control of the knee joint, and in patients whose weight, age, or activity level might cause extreme loads and early failure of the system.
Optctrak® HI-FLEX Tibial Inserts must be used with Optetrak® HI-FLEX Femoral Components.
CAUTION: In the USA, for cemented use only.
Product codes
JWH
Device Description
The device modifications to the femoral components presented in this Special 510(k) represent changes to the Optetrak® Asymmetric (AK), Posterior-Stabilized, Cemented Femoral Components (K032606) and the Optetrak® B-Series Postcrior-Stabilized Femoral Component (K010434). These changes represent a combination of
-
- The condyle, anterior cam, asymmetric flange and PCL stabilizing box geometries of the Optetrak® AK Femoral components, and
-
- The Posterior condyle radius and cam geometries of the Optetrak® B-Series Femoral Component
The device modifications to the tibial insert components presented in this Special 510(k) represent changes to the Optetrak® Posterior-Stabilized Tibial Inserts (K011976 and K933610) and changes to the Optetrak® B-scries Tibial Inserts (K010434). These changes represent a combination of:
-
- The articulating surfaces, mating geometry and anterior spine geometry of the Optetrak® Posterior-Stabilized Tibial Inscrts, and
-
- The posterior portion of the spine and the posterior scallops of the Optetrak® B-Series Tibial Insert Component
No changes were made to the patellar or tibial tray components of the Optetrak® Total Knec System.
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)
Verification and Validation analyses were conducted to verify that the implant performance would be adequate for anticipated in vivo loading.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
K033883
FEB 1 3 2004
Exactech Optetrak® Total Knee System Line Extension-Optetrak® HI-FLEX Knee Components Special 510(k)
Summary of Safety and Effectiveness
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Exactech® Inc. Sponsor: 2320 N.W. 66th Court Gainesville, Florida 32653 (352) 377-1140 Phonc: (352) 378-2617 Fax:
FDA Establishment Number: 1038671
- Contact: Dr. Gary Miller Vice President of Research and Development
Date:
1
K 033 88 3
p. 2/4
Exactech Optetrak® Total Knee System Line Extension-Optetrak® HI-FLEX Knee Components Special 510(k)
Summary of Safety and Effectiveness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Classifications / Proprietary Names: Prosthesis, Knee, Patellofemorotibial, Semi-Classification Name: Constrained, cemented, Polymer/Metal/Polymer Optetrak® Total Knee System Trade / Proprietary Model Namc: · HI-FLEX Asymmetric Posterior-Stabilized Cemented Femoral Components · HI-FLEX Posterior-Stabilized Tibial Insert Components JWH Product Code: 888.3560 C.F.R. Section: II Device Class: Orthopedic Classification Panel:
Exactech Legally Marketed Devices for Substantial Equivalence Comparison:
| Model | 510(k) Number |
|---|---|
| Optetrak® Total Knee System Tibial Component | K933610 |
| Optetrak® Size 0 and 1 Delta Line Extension | K011976 |
| Optetrak® Total Knee Asymmetric Femoral Components | K032606 |
| Optetrak® B-Series Total Knee System | K010434 |
Device Information:
INTENDED USE
The Optetrak® HI-FLEX Asymmetric Posterior-Stabilized Cemented Femoral Components (herein referred to as the Optetrak® HI-FLEX PS Femoral Components) and Optetrak® HI-FLEX Posterior-Stabilized Tibial Inscrts (Herein referred to as the HI-FLEX PS Tibial Inserts) are intended to be used with an Optetrak® Tibial Tray to replace the patient's distal fomur and proximal tibia during primary or revision total knee arthroplasty. The Optetrak® HI-FLEX PS Femoral components are intended for use when needed to closely
Section 4 Page 2 of 4
2
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p. 3/4
Exactech Optetrak® Total Knee System Line Extension-Optetrak® HI-FLEX Knee Components Special 510(k)
Summary of Safety and Effectiveness
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
match the geometry of the patient's resected distal femur and allows for more flexion than the standard Optetrak® components.
The Optetrak® HI-FLEX PS Tibial Insert is intended for use with the Optetrak® HI-FLEX PS Femoral components to afford the patient a higher degree of flexion than the standard Optetrak " femoral/tibial insert combination.
The proposed components are intended for use in total knee arthroplasty procedures in which the Posterior Cruciate Ligament (PCL) must be sacrificed.
All proposed femoral components are intended for cemented use only.
INDICATIONS
The OPTETRAK® Total Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knce replacement due to osteoarthritis, osteonecrosis, theurnatoid 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.
CONTRAINDICATIONS
The OPTETRAK® Total Knee Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate inscrtion and fixation of the prosthesis, patients without sufficient soft tissue integrity to provide adequate stability, and in patients with either mental or neuromuscular disorders that do not allow control of the knee joint, and in patients whose weight, age, or activity level might cause extreme loads and early failure of the system.
Optctrak® HI-FLEX Tibial Inserts must be used with Optetrak® HI-FLEX Femoral Components.
CAUTION: In the USA, for cemented use only.
Device Modifications
The device modifications to the femoral components presented in this Special 510(k) represent changes to the Optetrak® Asymmetric (AK), Posterior-Stabilized, Cemented
3
K033883
p. 4/4
Exactech Optetrak® Total Knee System Line Extension-Optetrak® HI-FLEX Knee Components Special 510(k)
Summary of Safety and Effectiveness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Femoral Components (K032606) and the Optetrak® B-Series Postcrior-Stabilized Femoral Component (K010434). These changes represent a combination of
-
- The condyle, anterior cam, asymmetric flange and PCL stabilizing box geometries of the Optetrak® AK Femoral components, and
-
- The Posterior condyle radius and cam geometries of the Optetrak® B-Series Femoral Component
The device modifications to the tibial insert components presented in this Special 510(k) represent changes to the Optetrak® Posterior-Stabilized Tibial Inserts (K011976 and K933610) and changes to the Optetrak® B-scries Tibial Inserts (K010434). These changes represent a combination of:
-
- The articulating surfaces, mating geometry and anterior spine geometry of the Optetrak® Posterior-Stabilized Tibial Inscrts, and
-
- The posterior portion of the spine and the posterior scallops of the Optetrak® B-Series Tibial Insert Component
No changes were made to the patellar or tibial tray components of the Optetrak® Total Knec System.
PERFORMANCE DATA SUMMARY
Verification and Validation analyses were conducted to verify that the implant performance would be adequate for anticipated in vivo loading.
We conclude that the Optetrak® Hi-FLEX PS Femoral Components and the Optetrak® Hi-FLEX PS Tibial Inserts are substantially equivalent to other devices legally marketed in the United States, most notably Exactech's predicate Optetrak® AK Femoral and Optetrak® Posterior-Stabilized tibial insert.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The symbol is positioned to the right of a circular emblem that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 2004
Gary J. Miller, Ph.D. Vice President of Research and Development Exactech, Inc. 2320 N.W. 66th Court Gainesville, Florida 32653
Rc: K033883 Trade/Device Name: Optetrak® Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: January 15, 2004 Received: January 16, 2004
Dear Dr. Miller:
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 sct 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.
5
Page 2 - Gary J. Miller, Ph.D.
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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Sincerely, yours,
Mark M. Milkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Exactech
2320 NW 66TH COU GAINFSVILLE, FL 326
Exactech Optetrak® Total Knee System Line Extension-Optetrak® HI-FLEX Knee Components Special 510(k)
352 377-1140 FAX 352-378-2617
Indications for Use
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
510(k) Number: #K033883
Device Name: Optetrak® Total Knce System
- . HI-FLEX Asymmetric Posterior-Stabilized Cemented Femoral Components
- HI-FLEX Posterior-Stabilized Tibial Insert Components .
INDICATIONS
The OPTETRAK® Total 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 degencrative problems. They arc also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
CONTRAINDICATIONS
The OPTETRAK® Total 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, and in patients with either mental or neuromuscular disorders that do not allow control of the knee joint, and in patients whose weight, age, or activity level might cause extreme loads and early failure of the system.
OPTETRAK® HI-FLEX Tibial Inserts must be used with Optetrak® HI-FLEX Femoral Components.
CAUTION: In the USA, for cemented use only.
Prescription Use (Part 21 CFR 801 D)
X
Over the C
Over the Counter Use
Mud. A. Millers
Division Sign Off
do not write below this line - use another page if needed.
or
e of CDRH, Office of Device Evaluation (ODE)
510(k) Number K033883
Section 3 Page 1 of 1