(15 days)
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.
This Special 510(k) submission is a line extension intended to add a low profile tibial tray to the Triathlon® Primary System.
The provided text describes a 510(k) premarket notification for a medical device called the Triathlon® Low Profile Tibial Tray. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with specific acceptance criteria as you might see for novel high-risk devices.
Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or available in this document. The primary "study" is a mechanical test for substantial equivalence.
Here's an attempt to answer based on the provided text, highlighting where information is not available:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Premarket Review Type: Substantial Equivalence to predicate devices | Demonstrated comparable mechanical properties to predicate components. |
| Intended Use: Used in total knee arthroplasty (TKA) for specific indications | Modifications do not alter the intended use of the Triathlon® Primary System. |
| Basic Design Concepts: Similar to existing Triathlon® and Scorpio® tibial trays | Shares the same intended use and basic design concepts as predicate devices. |
| Mechanical Properties: Comparable to predicate devices | Mechanical testing demonstrated comparable mechanical properties to the predicate components. |
Study Details:
-
Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The document mentions "mechanical testing" but does not give sample sizes for these tests.
- Data Provenance: Not specified, but generally, such mechanical testing is conducted in a laboratory setting by the manufacturer.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. "Ground truth" in this context refers to clinical outcomes or expert consensus in evaluating patient data. For a 510(k) based on mechanical testing for substantial equivalence, clinical ground truth establishment is not typically part of the submission. The "ground truth" for mechanical properties would be established by industry standards and comparison to predicate device performance.
-
Adjudication method for the test set:
- Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving human interpretation or subjective assessments. This document describes mechanical testing.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a medical device (tibial tray), not an AI diagnostic or image interpretation tool. Therefore, an MRMC study and AI-related effect size are not relevant.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a physical implant, not an algorithm.
-
The type of ground truth used:
- For the purpose of this 510(k), the "ground truth" for substantial equivalence was based on mechanical properties and design concepts being comparable to legally marketed predicate devices. This is established through laboratory biomechanical testing rather than clinical patient outcomes or expert pathology review which would be more relevant for higher-risk or novel devices.
-
The sample size for the training set:
- Not applicable/Not specified. This is not an AI model requiring a training set. The "training" for such a device would be its design, manufacturing processes, and material selection, informed by years of orthopedic implant knowledge.
-
How the ground truth for the training set was established:
- Not applicable. As this is not an AI model, there is no "training set ground truth" in the traditional sense. The design and manufacturing are based on existing engineering principles and medical understanding of orthopedic implants, ensuring the device meets established standards for safety and performance in a knee replacement.
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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 PatellofemorotibialPolymer/Metal/Polymer Semi-ConstrainedCemented Prosthesis, 21 CFR §888.3560 | |
| Device Product Code: | 87 JWH | |
| For Information Contact: | Francisco Haro, Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5493Fax: (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
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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.
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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.
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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
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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.
§ 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.