(28 days)
No
The summary describes a mechanical implant with material and design modifications, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a replacement for the patient's proximal tibia during primary or revision total knee arthroplasty due to medical conditions like osteoarthritis, osteonecrosis, rheumatoid arthritis, and post-traumatic degenerative problems, which points to a therapeutic function.
No
This device is a prosthesis intended to replace a patient's proximal tibia during knee arthroplasty, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines physical components made of materials like UHMWPE, titanium alloy, and cobalt-chromium, intended for surgical implantation. This is a hardware device, 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 to replace the patient's proximal tibia during total knee arthroplasty. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical implant made of materials like UHMWPE and cobalt-chromium, designed to be surgically implanted.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on sample analysis
- Reagents, calibrators, or controls
IVD devices are used to perform tests on samples taken from the body, not devices that are implanted into the body for therapeutic or structural purposes. This device falls under the category of a surgical implant.
N/A
Intended Use / Indications for Use
The Molded Metal-back Tibial components are intended to replace the patient's proximal tibia during primary or revision total knee arthroplasty. This device has been designed to substitute for the posterior stability of the Posterior Cruciate Ligament (PCL) and is intended for cemented application.
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 degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
In materials and design, the proposed Molded Metal-back Tibial components are a combination of:
-
The articulating surfaces of the Exactech Optetrak Tibial Tray Insert components (K933610 and K011976)
-
The tibial stem of the Cemented Finned Tibial Tray components (K932776 and K011976).
The proposed device modifications involve:
-
Modification to the portion of the modular assembly distal to the proximal articulating surface and proximal to the distal finned stem.
-
Revised cement fixation undercuts on the distal portion of the component
-
Integration of geometric undercuts to form a mechanical interlock between the UHMWPE and metallic portions of the component
-
A change in material of the finned stem portion from titanium alloy to cobaltchromium (CoCr)
No modifications have been made to the articular surface of the UHMWPE that interfaces with the femoral components. Nor have any configuration changes been made to the finned stem portion of the tibial bone interface.
There have been no changes to the material of the predicate Optetrak Total Knee bearing surface. Like the predicate Optetrak Total Knee tibial inserts, the proposed bearing surface is manufactured of Ultra-High Molecular Weight Polyethylene (UHMWPE) conforming to ASTM F648.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal tibia, 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)
Functional testing was 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K933610, K932776, K011976, K833921, K810520
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K030686 page '14'
Exactech® Optetrak® Total Knee System Line Extension -- Molded Metal-back Tibial Component Special 510(k)
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
APR 0 2 2003 Summary of Safety and Effectiveness
APR 02 2003
| Classification Name: | Prosthesis, Knee, Patellofemorotibial, Semi-
Constrained, Cemented, Polymer/Metal/Polymer |
|--------------------------------|----------------------------------------------------------------------------------------------|
| Trade/Proprietary Model Names: | Optetrak Total Knee System
Molded Metal-back Tibial Component |
| Product Code: | JWH |
| C.F.R. Section: | 888.3560 |
| Device Class: | II |
| Classification Panel: | Orthopedic |
Legally Marketed Devices for Substantial Equivalence Comparison:
| Model | Manufacturer | 510(k)# |
|---|---|---|
| Optetrak® Total Knee – Posterior Stabilized Tibial | ||
| Tray Insert Components | Exactech | K933610 |
| Exactech Cruciate Retaining Cemented Tibial | ||
| Components – Cemented Finned Tibial Tray | ||
| Components | Exactech | K932776 |
| Optetrak® Total Knee System: Size 0/1 Delta Line | ||
| Extension – Cemented Finned Tibial Tray Components | ||
| and Posterior Stabilized Tibial Inserts | Exactech | K011976 |
| AGC Total Knee Prosthesis - Posterior-Stabilized | ||
| Tibial Components | Biomet | K833921 |
| Insall/Burstein Constrained Total Condylar Knee | Zimmer | K810520 |
In materials and design, the proposed Molded Metal-back Tibial components are a combination of:
-
The articulating surfaces of the Exactech Optetrak Tibial Tray Insert components (K933610 and K011976)
-
The tibial stem of the Cemented Finned Tibial Tray components (K932776 and K011976).
1
Page 13
Exactech® Optetrak® Total Knee System Line Extension – Molded Metal-back Tibial Component Special 510(k)
Summary of Safety and Effectiveness
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Intended Use
The Molded Metal-back Tibial components are intended to replace the patient's proximal tibia during primary or revision total knee arthroplasty. This device has been designed to substitute for the posterior stability of the Posterior Cruciate Ligament (PCL) and is intended for cemented application.
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 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 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.
CAUTION: In the USA, for cemented use only.
Device Modifications
The device modifications presented in this Special 510(k) represent changes to the posterior stabilized, modular tibial insert and finned tibial tray components of the Optetrak Total Knee (K932776, K933610 and K011976). No changes were made to the femoral or patellar components of this system.
Section 4 Page Sof
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page 3 of 3
Exactech® Optetrak® Total Knee System Line Extension - Molded Metal-back Tibial Component Special 510(k)
Summary of Safety and Effectiveness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The proposed device modifications involve:
-
Modification to the portion of the modular assembly distal to the proximal articulating surface and proximal to the distal finned stem.
-
Revised cement fixation undercuts on the distal portion of the component
-
Integration of geometric undercuts to form a mechanical interlock between the UHMWPE and metallic portions of the component
-
A change in material of the finned stem portion from titanium alloy to cobaltchromium (CoCr)
No modifications have been made to the articular surface of the UHMWPE that interfaces with the femoral components. Nor have any configuration changes been made to the finned stem portion of the tibial bone interface.
There have been no changes to the material of the predicate Optetrak Total Knee bearing surface. Like the predicate Optetrak Total Knee tibial inserts, the proposed bearing surface is manufactured of Ultra-High Molecular Weight Polyethylene (UHMWPE) conforming to ASTM F648.
PERFORMANCE DATA SUMMARY
Functional testing was conducted to verify that the implant performance would be adequate for anticipated in vivo loading.
We conclude that the Molded Metal-back Tibial Components are substantially equivalent to other devices legally marketed in the United States, most notably Exactech's predicate Optetrak products.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 0 2 2003
Mr. Martin Sprunck Regulatory Representative Exactech, Inc. 2320 NW 66" Court Gainesville, Florida 32653
Re: K030686
Trade/Device Name: Optetrak® Total Knee System - Molded Metal Back Tibial Component Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: February 28, 2003 Received: March 5, 2003
Dear Mr. Sprunck:
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.
4
Page 2 - Mr. Martin Sprunck
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) 594-4639. 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 may be obtained 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/dsmarnain.html
Sincerely yours,
Sincerely yours,
Mark A. Millman
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
5
Exactech® Optetrak® Total Knee System Line Extension - Molded Metal-back Tibial Component Special 510(k)
Indications for Use
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
510(k) Number:
4030686
Device Name:
Molded Metal-back Tibial Component
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 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 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.
CAUTION: In the USA, for cemented use only.
Mark N Milkman
Division Sion-Off) Division of General, Restorative and Neurological Devices
X030686 510(k) Number_
Please do not write below this line - use another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Ym
or
Over the Counter Use No
Section 3 Page 1 of 1