(70 days)
The metal backed patella is intended for patellar resurfacing to alleviate pain, instability and the restriction of motion.
The Triathlon® Total Knee System components included in this submission are intended for use in total knee arthroplasty to relieve pain and restore knee functions for indications such as:
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis;
- Rheumatoid arthritis;
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed;
- Post traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and,
- Irreparable fracture of the knee.
These products are intended to achieve fixation without the use of bone cement.
The Triathlon® Metal Backed Patella is designed to offer patellar resurfacing when needed with the Duracon® or Triathlon® Total Knee Systems. The subject metal-backed patella is available in four sizes designed to fit the peripheral shape of the resected patella. The posterior surface of the patella features a porous coated metal back, with a preassembled polyethylene anterior surface.
This document is a 510(k) Summary for the Triathlon® Metal Backed Patella, a total knee joint replacement prosthesis. It outlines the device's description, intended use, indications for use, and claims substantial equivalence to a previously cleared device. Due to the nature of this document, which is a regulatory submission for a medical device that claims substantial equivalence rather than a study proving the device meets specific acceptance criteria, most of the requested information regarding acceptance criteria and a study proving performance is not present. This type of regulatory submission relies on comparison to a predicate device rather than presenting new clinical study data with defined acceptance criteria.
Therefore, many of the requested fields cannot be directly answered from the provided text.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or specific reported device performance metrics tied to such criteria. The device is cleared based on demonstrating substantial equivalence to a predicate device, not on meeting predefined performance acceptance thresholds through a new clinical performance study.
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. The document does not describe a test set or clinical study with sample sizes. Substantial equivalence is typically established through comparative data on design, materials, manufacturing processes, and indications for use, often leveraging existing data and reputation of the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. No test set or ground truth establishment by experts is described in this regulatory submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is described as there is no test set or clinical study.
5. 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
Not applicable. This is a knee implant, not an AI-assisted diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a knee implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No ground truth is described as there is no clinical study to establish performance against a ground truth. The "ground truth" for this submission is the established safety and effectiveness of the legally marketed predicate device.
8. The sample size for the training set
Not applicable. There is no training set for an algorithm in this context.
9. How the ground truth for the training set was established
Not applicable. There is no training set for an algorithm in this context.
Summary of Relevant Information from the Document:
- Device Name: Triathlon® Metal Backed Patella
- Predicate Device: Howmedica Osteonics' Duracon metal-backed patella (cleared in K032418)
- Claim of Substantial Equivalence: The metal-backed patella is substantially equivalent to the predicate device because it is "similar in design, and has the same indications, intended use, and sterilization."
- Role of Document: This is a 510(k) summary, a regulatory submission to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, thereby permitting its sale without requiring a new Premarket Approval (PMA). This process does not typically involve new clinical studies with defined acceptance criteria for the new device as would be required for a PMA or for novel devices not based on substantial equivalence.
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Kouszl (pg 1 of 2)
AUG 1 1 2006
510(k) Summary of Safety and Effectiveness for the Triathlon® Metal Backed Patella
Proprietary Name:
Triathlon Metal Backed Patella
Common Name:
Classification Name and Reference
Total Knee Joint Replacement Prosthesis
Knee Joint; Patellofemorotibial; Metal/polymer; Porous-coated; Uncemented prosthesis 21 CFR §888.3565
Regulatory Class:
Device Product Code:
For Information contact:
Class II
87 MBH - prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer.
Tiffani Rogers Regulatory Affairs Specialist Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey 07432 Phone: (201) 831-5412 Fax: (201) 831-6038 E-Mail: Tiffani.Rogers@stryker.com
Date Summary Prepared:
June 1, 2006
Device Description
The Triathlon® Metal Backed Patella is designed to offer patellar resurfacing when needed with the Duracon® or Triathlon® Total Knee Systems. The subject metal-backed patella is available in four sizes designed to fit the peripheral shape of the resected patella. The posterior surface of the patella features a porous coated metal back, with a preassembled polyethylene anterior surface.
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Intended Use:
The metal backed patella is intended for patellar resurfacing to alleviate pain, instability and the restriction of motion.
Indications for Use
•
The Triathlon® Total Knee System components included in this submission are intended for use in total knee arthroplasty to relieve pain and restore knee functions for indications such as:
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or . avascular necrosis;
- Rheumatoid arthritis; .
- Correction of functional deformity; .
- Revision procedures where other treatments or devices have failed; .
- Post traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, . dysfunction or prior patellectomy; and,
- Irreparable fracture of the knee. .
These products are intended to achieve fixation without the use of bone cement.
Substantial Equivalence:
The metal-backed patella is substantially equivalent to Howmedica Osteonics' Duracon metalbacked patella cleared in K032418. Each device is similar in design, and has the same indications, intended use, and sterilization.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 eagle with three lines representing its body and wings. The eagle is positioned to the right of a circular emblem that contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 1 2006
Howmedica Osteonics Corp. % Ms. Tiffani Rogers Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07432
Re: K061521
Trade/Device Name: Triathlon® Metal Backed Patella Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH Dated: June 1, 2006 Received: July 12, 2006
Dear Ms. Rogers:
We have reviewed your Section 510(k) premarket notification of intent to market the device w f na re reviews 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 arior 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 nat (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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA
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Page 2 - Ms. Tiffani Rogers
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 if you a 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 yours,
Barbara Buchner
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:
Indications for Use
The Triathlon® Total Knee System components included in this submission are intended for use in total knee arthroplasty to relieve pain and restore knee functions for indications such as:
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or . avascular necrosis;
- Rheumatoid arthritis; .
- Correction of functional deformity; .
- . Revision procedures where other treatments or devices have failed;
- Post traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, . dysfunction or prior patellectomy; and,
- Irreparable fracture of the knee. .
These products are intended to achieve fixation without the use of bone cement.
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)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_Kolo15 ज
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.