(13 days)
Not Found
No
The document describes a mechanical knee implant and its components, with no mention of software, algorithms, or any technology related to AI or ML.
No
The device is a knee implant system used for total knee replacement surgery, which is a structural support rather than a device that treats or prevents a disease.
No
This device is described as a component of a total knee replacement system (stem extensions), used during surgery for treatment, not for diagnosing a condition.
No
The device description clearly states the device is composed of Titanium alloy and is a physical implant (stem extension) for knee replacement surgery. It is not software.
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. This is a surgical procedure performed on the human body, not a test performed on samples taken from the body.
- Device Description: The device is a knee implant component (stem extension) made of titanium alloy. This is a physical implant, not a reagent, instrument, or system used to examine specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), providing diagnostic information, or being used in a laboratory setting.
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® Total Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, marradals and organis id arthritis and/or post-traumatic degenerative problems. They ore also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
CAUTION: For cemented use only in the USA.
Product codes
JWH
Device Description
Like the original Optetrak stem extensions, the proposed Optetrak Straight Stem Extension additional sizes are composed of Titanium alloy (ASTM F-1472). The proposed stem extensions have the same Morse taper call out and flute that the existing stem extensions offer. The design incorporates the same design features as the predicate Optetrak stem extensions over new lengths and diameters to create a complete range of sizes for the surgeon. The proposed Straight Stem Extension Line Extensions are fully compatible with the existing Optetrak Tibial Trapezoid trays (#K933610) and the Constrained Condlyar Femoral Component and bushing (#K954208).
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)
The design assurance reviews for the proposed products did not indicate the need for additional testing since the parts were so comparable to the existing Exactech stem extensions and no new failure modes were identified.
According to analytical analysis the proposed stem extension components showed that the stem extension strength was independent of length and diameter. Therefore, the proposed stem extensions should have the similar clinical results to the existing Exactech straight stem extensions.
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
KO12251
2320 NW 66TH COURT GAINESVILLE, FL 32653
352-377-1140 FAX 352-378-2617
JUL 3 1 2001
Exactech® Optetrak ™ Total Knee System Stem Extensions - Additional Sizes
510(k) Summary of Safety and Effectiveness Special 510(k)
Exactech® Inc. Sponsor: 2320 N.W. 66th Court Gainesville, Florida 32653
| Phone: | (352) - 377 - 1140 |
|---|---|
| Fax: | (352) - 378 - 2617 |
FDA Establishment Number 1038671
Robert Paxson Contact: Director of Engineering & Development
Date:
June 22, 2001
Section 4 Page 1 of 4
1
Exactech® Optetrak ™ Total Knee System Stem Extensions - Additional Sizes
510(k) Summary of Safety and Effectiveness Special 510(k)
Classifications / Proprietary Names:
Classification Name:
Prosthesis, knee, patellofemorotibial, semi-contrained, cemented, polymer/metal polymer
Trade / Proprietary Model Names:
Optetrak Total Knee System Stem Extensions - Additional Sizes
JWH Product Code: 888.3560 C.F.R. Section:
II Device Class:
Classification Panel: Orthopedic
Legally Marketed Devices for Substantial Equivalence Comparison:
| Model | Manufacturer | 510(k) Number |
|---|---|---|
| Optetrak Total Knee | ||
| Optetrak Total Knee | Exactech | |
| Exactech | #K933610 | |
| #K954208 | ||
| Nexgen | Zimmer | -------- |
| Maxim | Biomet | -------- |
| Durcon Total Stabilizer | Howmedica | -------- |
Device Information:
INDICATIONS
The OPTETRAK® Total Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, marradals and organis id arthritis and/or post-traumatic degenerative problems. They ore also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
CAUTION: For cemented use only in the USA.
2
Exactech® Optetrak ™ Total Knee System Stem Extensions - Additional Sizes
510(k) Summary of Safety and Effectiveness Special 510(k)
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.
DEVICE DESCRIPTION
Like the original Optetrak stem extensions, the proposed Optetrak Straight Stem Extension additional sizes are composed of Titanium alloy (ASTM F-1472). The proposed stem extensions have the same Morse taper call out and flute that the existing stem extensions offer. The design incorporates the same design features as the predicate Optetrak stem extensions over new lengths and diameters to create a complete range of sizes for the surgeon. The proposed Straight Stem Extension Line Extensions are fully compatible with the existing Optetrak Tibial Trapezoid trays (#K933610) and the Constrained Condlyar Femoral Component and bushing (#K954208).
| Packaging Materials | |
|---|---|
| Material | Composition |
| Vacuum Bag | High Barrier – 3 Mil, 75 gauge |
| Nylon with EVOH 2.25 Polyethylene | |
| Polymer Bags | 3 Mil Polyethylene |
| Inner/Outer Pouches | 48GAPET/.002LDPE |
| Pouch Seals | 1073B Uncoated Tyvek® |
| Box | Heavy weight cardboard |
| Outer Shrink-Wrap | Clear, Light-Weight Plastic |
| Shipping Cartons | Heavy-weight Corrugated Cardboard |
PACKAGING MATERIALS
STERILIZATION INFORMATION
Method: Gamma radiation (Cobalt 60 source) Dose: 25 - 37 kGy Sterility Assurance Level (SAL): 10-6
3
Exactech® Optetrak ™ Total Knee System Stem Extensions - Additional Sizes
510(k) Summary of Safety and Effectiveness Special 510(k)
PERFORMANCE DATA
The design assurance reviews for the proposed products did not indicate the need for additional testing since the parts were so comparable to the existing Exactech stem extensions and no new failure modes were identified.
According to analytical analysis the proposed stem extension components showed that the stem extension strength was independent of length and diameter. Therefore, the proposed stem extensions should have the similar clinical results to the existing Exactech straight stem extensions.
We conclude that the new Optetrak Stem Extensions are substantially equivalent to other devices legally marketed in the United States, most notably Exactech's predicate Optetrak products.
4
Image /page/4/Picture/1 description: The image shows the text "Public Health Service" in a simple, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or institutional context.
Image /page/4/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The eagle is positioned in the center of a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
JUL 3 1 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert Paxson Director of Engineering & Development Exactech. Inc. 2320 N.W. 66th Court Gainsville, Florida 32653
Re: K012251
Trade Name: Optetrak Total Knee System Regulatory Class: II Regulation Number: 888.3560 Product Code: JWH Dated: July 17, 2001 Received: July 18, 2001
Dear Dr. Paxson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
5
Page 2 - Mr. Robert Paxson
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 11 you desire specific darices), please contact the Office of Compliance at additionally 609110 for questions on the promotion and advertising of your device, (2017) 59 + 105 + 1 = 0 ffice of Compliance at (301) 594-4639. Also, please note the regulation predise ounder the Oriety of eference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
R.M.M.h.l.u.u.m.o. P.R.
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® Optetrak Total Knee System Straight Stem Extensions - Additional Sizes
Indications for Use
510(k) Number:
K. 2-25|
Device Name:
Optetrak Total Knee System Straight Stem Extensions
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.
CAUTION: For cemented use only in the USA.
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.
smhheeein2
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K012251
Please do not write below this line - use another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
or
Over the Counter Use
Section 3 Page 1 of 1