(92 days)
Not Found
No
The summary describes a mechanical knee prosthesis and does not mention any AI or ML components or functionalities.
Yes
The device is a knee prosthesis intended for replacement of a diseased knee, which aligns with the definition of a therapeutic device as it treats a medical condition.
No
The device is described as a modular unicondylar knee prosthesis intended for replacement of joint components, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "modular unicondylar knee prostheses consisting of sterile, single-use components intended for replacement of the medial or lateral femoral condyle regions". This describes physical implants, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a surgical implant (a knee prosthesis) that is surgically placed within the body to replace damaged joint components.
- Intended Use: The intended use clearly states it's for treating joint disease of the knee and is implanted with bone cement. This is a therapeutic intervention, not a diagnostic test performed on a specimen outside the body.
The information provided consistently points to a medical device used for surgical treatment, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
- Moderately disabling joint disease of the knee resulting from painful osteo- or post . traumatic arthritis
- Revision of previous unsuccessful surgical procedures, either involving, or not . involving, previous use of a unicompartmental knee prosthesis
- As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis .
- Where bone stock is of poor quality or inadequate for other reconstructive techniques as . indicated by deficiencies of the femoral condyle/tibial plateau.
These components are intended for implantation with bone cement.
Product codes
HRY
Device Description
The Triathlon® PKR System is a modular unicondylar knee prostheses consisting of sterile, single-use components intended for replacement of the medial or lateral femoral condyle regions for either the right or left knee.
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)
Based upon the mechanical testing, the Triathlon® PKR System is substantially equivalent for its intended use to other femorotibial replacement knees currently on the market.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K031729, K040267, K051146, K063423, K992287, K033769, K896856, K911373, K923011
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows a handwritten note with the text "K07/881" on the top line. Below that, the date "OCT - 9 2007" is printed. The text appears to be a combination of handwritten and machine-printed elements.
510(k) Summary of Safety and Effectiveness Triathlon® Knee System Line Extension
Submission Information
Name and Address of the Sponsor of the 510(k) Submission:
For Information contact:
Howmedica Osteonics Corp 325 Corporate Drive Mahwah, NJ 07430
Vivian Kelly, Sr. Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: (201) 831-5581 Fax: (201) 831-6038
Date Summary Prepared:
Device Identification
Proprietary Name: Common Name: Classification Name and Reference:
Proposed Regulatory Class: Device Panel/Product Code: July 6, 2007
Triathlon® PKR System Knee Prosthesis Components Knee Joint, Femorotibial, Polymer/Metal, Semi-constrained, Cemented Prosthesis, 21 CFR §888.3530 Class II 87 HRY, Prosthesis, Knee, Femorotibial, semi-constrained, Cemented, Metal/Polymer
Description:
The Triathlon® PKR System is a modular unicondylar knee prostheses consisting of sterile, single-use components intended for replacement of the medial or lateral femoral condyle regions for either the right or left knee.
Indications for Use:
- Moderately disabling joint disease of the knee resulting from painful osteo- or post . traumatic arthritis
- Revision of previous unsuccessful surgical procedures, either involving, or not . involving, previous use of a unicompartmental knee prosthesis
- As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis .
- Where bone stock is of poor quality or inadequate for other reconstructive techniques as . indicated by deficiencies of the femoral condyle/tibial plateau.
These components are intended for implantation with bone cement.
Substantial Equivalence:
The device is substantially equivalent to its predicates for femorotibial arthroplasty in regards to intended use, design, materials, and operational principles. The analyses demonstrate that the components from these systems are compatible when used for femorotibial replacement. Examples of predicate knee systems include the Triathlon® Knee System (K031729, K040267) and X30 UHMWPE Tibial Inserts and Patellar Components (K051146 & K063423), the EIUS® Unicompartmental Knee System (K992287 & K033769), the SCR® Unicompartmental Knee Prosthesis (K896856 & K911373) and the UNIX™ Unicompartmental Knee System (K923011.) Based upon the mechanical testing, the Triathlon® PKR System is substantially equivalent for its intended use to other femorotibial replacement knees currently on the market.
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 9 2007
Howmedica Osteonics Corp. % Ms. Vivian Kelly, RAC Senior Regulatory Affairs Specialist 325 Corporate Drive Mahwah, NJ 07430
Re: K071881
Trade/Device Name: Triathlon PKR System Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HRY Dated: July 6, 2007 Received: July 9, 2007
Dear Ms. Kelly:
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 mav 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
2
Page 2 - Ms. Vivian Kelly
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Ambare Bnehn
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K071881
Device Name: Triathlon® PKR System
Indications for Use:
- Moderately disabling joint disease of the knee resulting from painful osteo- or post . traumatic arthritis
- Revision of previous unsuccessful surgical procedures, either involving, or not ◆ involving, previous use of a unicompartmental knee prosthesis
- . As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis
- Where bone stock is of poor quality or inadequate for other reconstructive techniques as . indicated by deficiencies of the femoral condyle/tibial plateau.
These components are intended for implantation with bone cement.
Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)
Chau Buehly Nixon
Division Sign. Off
Page 1 of 1
Division of General, Restorative
and Neurological Devices
510(k) Number K071881
5