(95 days)
Not Found
No
The document describes a traditional knee implant system and does not mention any AI or ML components or functionalities.
Yes
The device is a total knee system intended to alleviate pain and restore function in patients with painful, disabling joint disease of the knee, which aligns with the definition of a therapeutic device.
No
This device, the Triathlon® Total Knee System, is an orthopedic implant intended for surgical replacement of the knee joint to alleviate pain and restore function. It does not perform any diagnostic function.
No
The device description clearly outlines physical components (femoral and tibial components made of cast cobalt chrome with porous coating) intended for surgical implantation, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes a surgical implant (a total knee system) intended to be surgically placed within the human body to replace a damaged knee joint.
- Intended Use: The intended use is to "alleviate pain and restore function" through surgical implantation, not through testing bodily samples.
The Triathlon® Total Knee System is a medical device, specifically a prosthetic implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Triathlon® Total Knee System is intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. The Triathlon® Total Knee System is intended for cementless use only.
- Painful, disabling joint disease of the knee resulting from: noninflammatory . degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid 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 knee replacement or other procedure. ●
- Fracture of the distal femur and/or proximal tibia that cannot be stabilized by . standard fracture management techniques.
Additional Indications for Posterior Stabilized Components:
- Ligamentous instability requiring implant bearing surface geometries with . increased constraint.
- Absent or non-functioning posterior cruciate ligament.
The Triathlon® Total Knee System beaded and beaded with Peri-apatite components are intended for uncemented use only.
Product codes (comma separated list FDA assigned to the subject device)
87 MBH, MBH
Device Description
The Triathlon® Total Knee System will be available with femoral and tibial components in a cementless design with and without Stryker Howmedica Osteonics' Peri-apatite (PA) coating. The Triathlon® fixed bearing cementless baseplate and femoral components are compatible with the current Triathlon® tibial inserts and patellas. The Triathlon® components proposed in this submission are manufactured from cast cobalt chrome and have a cobalt chrome porous coating, available with and without a PA coating. The Triathlon® tibial component is fixed bearing and will be provided in sizes 1 through 8.
The femoral components will be offered in both cruciate retaining (CR) and posterior stabilizing (PS) versions, also in sizes 1 through 8.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
K042993, K040267, K032163, K032418
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
§ 888.3565 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.
0
AUG 3 0 2005
OSTEONICS
325 Corporate Drive 510(k) Summary of Safety and Effectiveness for the Mahwah, NJ USA 07430 Triathlon® Total Knee System
| Proprietary Name: | Triathlon™ Total Knee System |
|---|---|
| Common Name: | Total Knee Joint Replacement Prosthesis |
| Classification Name and Reference | Knee joint patellofemorotibial |
| metal/polymer porous-coated uncemented | |
| prosthesis. | |
| 21 CFR §888.3565 | |
| Regulatory Class: | Class II |
| Device Product Code: | 87 MBH - prosthesis, knee, |
| patello/femorotibial, semi-constrained, | |
| uncemented, porous, coated, | |
| polymer/metal/polymer, | |
| For Information contact: | 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: | August 11, 2005 |
Device Description
The Triathlon® Total Knee System will be available with femoral and tibial components in a cementless design with and without Stryker Howmedica Osteonics' Peri-apatite (PA) coating. The Triathlon® fixed bearing cementless baseplate and femoral components are compatible with the current Triathlon® tibial inserts and patellas. The Triathlon® components proposed in this submission are manufactured from cast cobalt chrome and have a cobalt chrome porous coating, available with and without a PA coating. The Triathlon® tibial component is fixed bearing and will be provided in sizes 1 through 8.
1
The femoral components will be offered in both cruciate retaining (CR) and posterior stabilizing (PS) versions, also in sizes 1 through 8.
Intended Use:
The Triathlon® Total Knee System is intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. The Triathlon® Total Knee System is intended for cementless use only.
Indications
- Painful, disabling joint disease of the knee resulting from: noninflammatory . degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid 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 knee replacement or other procedure. ●
- Fracture of the distal femur and/or proximal tibia that cannot be stabilized by . standard fracture management techniques.
Additional Indications for Posterior Stabilized Components:
- Ligamentous instability requiring implant bearing surface geometries with . increased constraint.
- Absent or non-functioning posterior cruciate ligament. .
Substantial Equivalence:
The determination of the substantial equivalence of the Triathlon® Total Knee System is based on its similarities in intended use, design and sterilization to Howmedica Osteonics' Triathlon® PS Total Knee System (K042993, cleared January 12, 2005), Triathlon® CR Total Knee System (K040267, cleared May 05, 2004), Duracon® Total Knee System (K032163, cleared September 12, 2003 and K032418 cleared, September 11, 2003). Predicate device information is located in Appendix D.
2
Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in bold, black font. The words are arranged on a single line, with "Public Health" appearing before "Service". The text is simple and straightforward, likely serving as a heading or label.
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
AUG 3 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Tiffani Rogers Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430
Re: K051380 K051580
Trade/Device Name: Triathlon® Total Knee System Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: II Product Code: MBH Dated: August 11, 2005 Received: August 13, 2005
Dear Ms. Rogers:
We have reviewed your Section 510(k) premarket notification of intent to market the device indicati We nave reviewed your Security promation is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regarly manatinent date of the Medical Device American be and Food. Fore commerce prior to May 28, 1776, the encenters with the provisions of the Federal Food. Drug. devices that have been reclassified in accerdance "rius can as a proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applica and Cosment Act (Act) that do not require approvision the general controls provisions of the Act. The You may, therefore, market the devrees, books of the Act annual registration, listing of general controls provisions of the Feet 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 If your device is classified (300 abor b) als. Existing major regulations affecting your device can may be subject to such additional controller in the 21, Parts 800 to 898. In addition, FDA may be found in the Ood of Peaces and one one one on the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oe advised that I Dri- s issuation of a backers.
that FDA has made a determination that your device complies with other requirements of the Act that FDA has made a determination administered by other Federal agencies. You must of any Federal Statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Fart 807), adoning (21 CFR Part 820); good if applicable, the electronic form in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2-Ms. Tiffani Rogers
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oegin manxellig your device of your device to a legally premarket notification. THC PDA miang of 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 desire specific advice for your at 110 %. Also, please note the regulation entitled, the regulation entitled, colliact the Office of Computers as (21 trotification" (21CFR Part 807.97). You may obtain " Misoranding by relevelec to premance to premance the Act from the Division of Small
on of Small other general information on your responsibilities and its toll-free number (800) 638-204 or Manufacturers, internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerety yours,
Sincerely yours,
Mark N. Melkerson
Acting 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): ____K051380
Device Name: Triathlon® Total Knee System ____________________________________________________________________________________________________________________________________
Indications
- Painful, disabling joint disease of the knee resulting from: noninflammatory . r unrai, assasting joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis.
- Post-traumatic loss of knee joint configuration and function. .
- r ost traintanes, valgus, or flexion deformity in which the ligamentous structures . can be returned to adequate function and stability.
- Revision of previous unsuccessful knee replacement or other procedure. .
- Fracture of the distal femur and/or proximal tibia that cannot be stabilized by . standard fracture management techniques.
Additional Indications for Posterior Stabilized Components:
- I identions instability requiring implant bearing surface geometries with . increased constraint.
- Absent or non-functioning posterior cruciate ligament. .
The Triathlon® Total Knee System beaded and beaded with Peri-apatite components are intended for uncemented use only.
Prescription Use Use___________________________________________________________________________________________________________________________________________________________________________
OR
Over-the-Counter
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Devies Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number Ko51380