(15 days)
Not Found
Not Found
No
The summary describes a mechanical knee implant component and its intended use, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes
The device is a knee component intended to treat painful, disabling joint disease and post-traumatic loss of knee joint function, which are therapeutic indications.
No
Explanation: The device is a total knee arthroplasty component, specifically a tibial tray, used in surgery to replace a diseased knee joint. It is a treatment device, not one that diagnoses conditions.
No
The device description clearly states it is a "tibial tray knee component," which is a physical implant used in surgery, not software.
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 a "sterile, single use tibial tray knee component intended to be used in total knee arthroplasty (TKA)." This describes a surgical implant used in the body, not a device used to test samples outside the body (which is the definition of an IVD).
- Device Description: The description reinforces that it's a "low profile tibial tray to the Triathlon® Primary System," again indicating a physical component for surgery.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue), detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, this device is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The modifications do not alter the intended use of the predicate system as cleared in the referenced premarket notifications. The subject and predicate devices are sterile, single use tibial tray knee components intended to be used in total knee arthroplasty (TKA). The indications for use for the Triathlon® Low Profile Tibial Tray are provided below.
Indications for Use:
- Painful, disabling joint disease of the knee resulting from: degenerative . arthritis, rheumatoid arthritis or post-traumatic arthritis.
- . Post-traumatic loss of knee joint configuration and function.
- . Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
The Triathlon® Low Profile Tibial Tray is intended to be used with commercially available Triathlon® femoral components and associated patellar components, and tibial bearing inserts in primary cemented total knee arthroplasty. The indications/contraindications for the Triathlon® Low Profile Tibial Tray are outlined below:
Indications for Use:
- · Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
- · Post-traumatic loss of knee joint configuration and function.
- · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
Product codes (comma separated list FDA assigned to the subject device)
87 JWH, JWH
Device Description
This Special 510(k) submission is a line extension intended to add a low profile tibial tray to the Triathlon® Primary 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
Not Found
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 testing demonstrated comparable mechanical properties to the predicate components and substantial equivalence to these devices.
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.
Not Found
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
AUG 0 3 2006
K06-2037
Page 1 of 2
Summary of Safety and Effectiveness Triathlon® Low Profile Tibial Tray
| Proprietary Name: | Triathlon® Low Profile Tibial Tray | |
|---|---|---|
| Common Name: | Tibial Tray Knee Component | |
| Classification Name and Reference | Knee Joint Patellofemorotibial | |
| Polymer/Metal/Polymer Semi-Constrained | ||
| Cemented Prosthesis, 21 CFR §888.3560 | ||
| Device Product Code: | 87 JWH | |
| For Information Contact: | Francisco Haro, Regulatory Affairs Specialist | |
| Howmedica Osteonics Corp. | ||
| 325 Corporate Drive | ||
| Mahwah, NJ 07430 | ||
| Phone: (201) 831-5493 | ||
| Fax: (201) 831-6038 | ||
| Date Summary Prepared: | July 14, 2006 |
Date Summary Prepared:
Description:
This Special 510(k) submission is a line extension intended to add a low profile tibial tray to the Triathlon® Primary System.
Intended Use:
The modifications do not alter the intended use of the predicate system as cleared in the referenced premarket notifications. The subject and predicate devices are sterile, single use tibial tray knee components intended to be used in total knee arthroplasty (TKA). The indications for use for the Triathlon® Low Profile Tibial Tray are provided below.
Indications for Use:
- Painful, disabling joint disease of the knee resulting from: degenerative . arthritis, rheumatoid arthritis or post-traumatic arthritis.
- . Post-traumatic loss of knee joint configuration and function.
- . Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
б
1
06-2037 Page 2 of 2
Substantial Equivalence:
The subject Triathlon® Low Profile Tibial Tray shares the same intended use, and basic design concepts as that of the currently available tibial trays of the Triathlon® Posterior Stabilizing (PS) Total Knee System, Triathlon® Cruciate Retaining (CR) Total Knee System, and Scorpio® Low Profile Tibial Tray. Mechanical testing demonstrated comparable mechanical properties to the predicate components and substantial equivalence to these devices.
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 caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is a symbol of medicine and healing. The logo also includes the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG () 3 2006
Howmedica Osteonics Corp. % Mr. Francisco Haro Regulatory Affairs Specialist 325 Corporate Drive Mahwah. New Jersey 07430
Re: K062037
Trade/Device Name: Triathlon® Low Profile Tibial Tray 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: July 14, 2006
Ta 1 X
Received: July 19, 2006
Dear Mr. Haro:
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. Francisco Haro
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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Hulud Lemmeruo
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: Triathlon® Low Profile Tibial Tray
The Triathlon® Low Profile Tibial Tray is intended to be used with commercially available Triathlon® femoral components and associated patellar components, and tibial bearing inserts in primary cemented total knee arthroplasty. The indications/contraindications for the Triathlon® Low Profile Tibial Tray are outlined below:
Indications for Use:
- · Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
- · Post-traumatic loss of knee joint configuration and function.
- · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
Contraindications:
- Any active or suspected latent infection in or about the knee joint. .
- Any mental or neuromuscular disorder which would create an unacceptable risk of . prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
- Bone stock compromised by disease, infection or prior implantation which cannot . provide adequate support and/or fixation to the prosthesis.
- Skeletal immaturity. �
- Severe instability of the knee joint secondary to the absence of collateral ligament ● integrity and function.
- Obesity. An overweight or obese patient can produce loads on the prosthesis which can . lead to failure of the fixation of the device or to failure of the device itself.
- The use of bone augmentations is contraindicated with the low profile tibial trays. ●
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| Over-The-Counter Use | |
| (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
39
510(k) Number.