(41 days)
General Total Knee Arthroplasty (TKA) Indications
- 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.
- . Revision of previous unsuccessful uni-knee replacement or other procedure.
Additional Indications for Universal Baseplates and Stem Components:
- Ligamentous instability requiring implant bearing surface geometries with increased constraint. ●
- Absent or non-functioning posterior cruciate ligament. .
Indications for Bone Augments:
- Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.
- Salvage of previous unsuccessful uni-knee replacement or other surgical procedure, accompanied . by bone loss.
The Triathlon® Total Knee System components are intended for cemented use only.
Not Found
The provided text does not contain any information about acceptance criteria or a study proving device performance, as it is an FDA 510(k) clearance letter for the Triathlon® Total Knee System. This letter confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements. It does not include details on clinical studies, performance metrics, ground truth, or expert involvement for AI/device performance evaluation.
Therefore, I cannot provide the requested table and study details based on the given input.
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Image /page/0/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 coiled around it. The caduceus is a symbol of medicine and healing. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 6 2006
Ms. Tiffani D. Rogers Specialist, Regulatory Affairs Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430
Re: K053514
Trade/Device Name: Triathlon® Total Knee System 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: December 15, 2005 Received: December 16, 2005
Dear Ms. Rogers:
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. Iisting 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
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Page 2 - Ms. Rogers
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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" (21 CFR 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/cdrl/industry/support/index.html.
Sincerely vours.
Houbara Buchum
Mark N. Melkerson, Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ-410 Division D.O. f/t:PGA:rrr: 1/25/06
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510(k) Number (if known): K0535/4
Device Name: Triathlon® Total Knee System
Indications for Use
General Total Knee Arthroplasty (TKA) Indications
- 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.
- . Revision of previous unsuccessful uni-knee replacement or other procedure.
Additional Indications for Universal Baseplates and Stem Components:
- Ligamentous instability requiring implant bearing surface geometries with increased constraint. ●
- Absent or non-functioning posterior cruciate ligament. .
Indications for Bone Augments:
- Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid � arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.
- Salvage of previous unsuccessful uni-knee replacement or other surgical procedure, accompanied . by bone loss.
The Triathlon® Total Knee System components are intended for cemented use only.
X Prescription Use
OR (Per 21 CFR 801.109)
Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
barbarc Bucum
storative. and Neurological I
510(k) Number K053514
§ 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.