(66 days)
Not Found
No
The summary describes a mechanical knee implant system and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device, a component of a total knee arthroplasty system, is intended to alleviate pain and restore function in individuals with disabling knee joint diseases, which aligns with the definition of a therapeutic device.
No
The device is a component of a total knee arthroplasty system, intended to alleviate pain and restore function in the knee. It is a therapeutic device, not a diagnostic one, as it does not diagnose a condition but rather treats an existing one.
No
The device description clearly describes physical components (tibial inserts, metal locking wire, tibial baseplates) which are hardware, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "primary and revision total knee arthroplasty to alleviate pain and restore function." This is a surgical procedure performed on the body, not a test performed on samples taken from the body.
- Device Description: The description details physical components (tibial inserts, tibial post, locking wire) that are implanted into the knee joint. This is consistent with a surgical implant, not an IVD.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
The device is a surgical implant used to replace or repair a damaged knee joint.
N/A
Intended Use / Indications for Use
The Triathlon TS Total Knee System tibial components are intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. All tibial components presented in this submission are provided sterile for single-use.
General Total Knee Arthroplasty (TKR) 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 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 (PS) and Total Stabilizer (TS) Components:
- Ligamentous instability requiring implant bearing surface geometries with increased . constraint.
- Absent or non-functioning posterior cruciate ligament. .
- Severe anteroposterior instability of the knee joint. .
Additional Indications for Total Stabilizer (TS) Components:
- Severe instability of the knee secondary to compromised collateral ligament integrity or . function.
The Triathlon TS Total Knee System components are intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The Triathlon TS Total Knee System features TS and TS Plus tibial inserts available in sizes 1 through 8 and thicknesses from 9mm to 31mm. These tibial inserts used with the Triathlon TS Total Knee System have been modified. The tibial inserts feature an open cam box with a tibial post slot to accommodate a cobalt chrome tibial post intended for additional stability in the knee joint. The Triathlon TS tibial inserts also feature a metal locking wire for assembly into previously cleared Triathlon tibial baseplates. The Triathlon TS Plus and the Triathlon TS inserts are available in sequentially crosslinked and standard polyethylene.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 888.3560 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.
0
007 1 5 2007
Howmedica
OSTEONICS
325 Corporate Drive Mahwah, NJ USA 07430
510(k) Summary of Safety and Effectiveness for the Triathlon® TS Knee System
| Proprietary Name: | Triathlon® TS Knee System |
|---|---|
| Common Name: | Total Knee Joint Replacement Prosthesis |
| Classification Name and Reference | Joint patellofemorotibial polymer/metal/polymer |
| semi-constrained cemented prosthesis. | |
| 21 CFR §888.3560 | |
| Regulatory Class: | Class II |
| Device Product Code: | 87 JWH - prosthesis, knee, patellofemorotibial, |
| semi-constrained, cemented, | |
| polymer/metal/polymer | |
| For Information contact: | Tiffani Rogers |
| Regulatory Affairs Specialist | |
| Stryker Orthopaedics | |
| 325 Corporate Drive | |
| Mahwah, New Jersey 07432 | |
| Phone: (201) 831-5612 | |
| Fax: (201) 831-6038 | |
| E-Mail: Tiffani.Rogers@stryker.com | |
| Date Summary Prepared: | August 8, 2007 |
Device Description
The Triathlon TS Total Knee System features TS and TS Plus tibial inserts available in sizes 1 through 8 and thicknesses from 9mm to 31mm. These tibial inserts used with the Triathlon TS Total Knee System have been modified. The tibial inserts feature an open cam box with a tibial post slot to accommodate a cobalt chrome tibial post intended for additional stability in the knee joint. The Triathlon TS tibial inserts also feature a metal locking wire for assembly into
1
previously cleared Triathlon tibial baseplates. The Triathlon TS Plus and the Triathlon TS inserts are available in sequentially crosslinked and standard polyethylene.
Intended Use:
The Triathlon TS Total Knee System tibial components are intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. All tibial components presented in this submission are provided sterile for single-use.
Indications for Use
General Total Knee Arthroplasty (TKR) 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 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 (PS) and Total Stabilizer (TS) Components:
- Ligamentous instability requiring implant bearing surface geometries with increased . constraint.
- Absent or non-functioning posterior cruciate ligament. .
- Severe anteroposterior instability of the knee joint. .
Additional Indications for Total Stabilizer (TS) Components:
- Severe instability of the knee secondary to compromised collateral ligament integrity or . function.
The Triathlon TS Total Knee System components are intended for cemented use only.
Substantial Equivalence:
The determination of substantial equivalence of the Triathlon TS Total Knee System tibial inserts is based on its similarities in indications for use, intended use, design and sterilization to Howmedica Osteonics' Triathlon TS Total Knee System (K070095, cleared June 01, 2007).
2
Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 5 2007
Howmedica Osteonics Corp. % Ms. Tiffani Rogers Regulatory Affairs Specialist Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey 07432
Re: K072221
Trade/Device Name: Triathlon® TS Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: September 27, 2007 Received: September 28, 2007
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, 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
3
Page 2 - Ms. Tiffani Rogers
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 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 yours.
Darbage Buelin
Sen
Mark N. Me kerson 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): _ K072221
Device Name:
Indications for Use
General Total Knee Arthroplasty (TKR) 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 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 (PS) and Total Stabilizer (TS) Components:
- Ligamentous instability requiring implant bearing surface geometries with increased . constraint.
- Absent or non-functioning posterior cruciate ligament. .
- Severe anteroposterior instability of the knee joint. .
Additional Indications for Total Stabilizer (TS) Components:
- Severe instability of the knee secondary to compromised collateral ligament integrity or . function.
The Triathlon TS Total Knee System components are intended for cemented use only.
Prescription Use
OR Over-the-Counter Use (Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Division of General, Restorative, and Neurological 510(k) I