(171 days)
Not Found
No
The 510(k) summary describes a mechanical orthopedic implant (tibial baseplate) and its compatibility with other components. There is no mention of software, algorithms, image processing, AI, ML, or any data-driven decision-making capabilities. The performance studies focus on mechanical properties and wear, typical for such devices.
Yes
The device is a tibial baseplate designed to be implanted in Total Knee Arthroplasty procedures to address painful and disabling joint disease of the knee, which aligns with the definition of a therapeutic device as it is intended to alleviate or cure a medical condition.
No
Explanation: The device described is a tibial baseplate for total knee arthroplasty, which is an implant used in surgical procedures, not a tool for diagnosing medical conditions. Its purpose is to replace part of a joint, not to identify diseases or conditions.
No
The device is a physical implant (tibial baseplate) used in knee replacement surgery, not a software application.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for Total Knee Arthroplasty procedures. This is a medical device used in vivo (within the body) for treatment, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description details a tibial baseplate, which is a component of a knee replacement implant. It is designed to be surgically implanted.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
Therefore, the Triathlon® Tritanium Tibial Baseplates are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Triathlon® Tritanium Tibial Baseplates are designed to be implanted with or without bone cement in primary or revision Total Knee Arthroplasty procedures.
General Total Knee Arthroplasty (TKR) Indications:
- Painful, disabling joint disease of the knee resulting from: non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis), theumatoid 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 Stabilizing (PS) 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
The Triathlon® Tibial Baseplates are indicated for both cemented and uncemented use.
Product codes (comma separated list FDA assigned to the subject device)
MBH, JWH
Device Description
The Triathlon Tritanium Tibial Baseplate is an extension of the Triathlon® Total Knee System product line for use in primary or revision Total Knee Arthroplasty. It is a sterile, single patient use, tibial baseplate and will be offered in the same size range as the current Triathlon® cementless baseplates (Sizes 1-8). This porous-coated baseplate is for use in both cemented and cementless applications. The Triathlon® Tritanium Tibial Baseplates are packaged with a sterile, single patient use, disposable Impactor Pad in-The Impaction Pad is to be used during the tibial baseplate impaction step only, and is to situ. be discarded once the impaction has been completed. The Impaction Pad is not for implantation.
The Triathlon® Tritanium Tibial Baseplate is compatible for use with the Triathlon® PS, CS and CR Tibial Inserts (NoVac or X3 polyethylene), Triathlon® PS and CR Femoral components (cemented & cementless), Triathlon Symmetric Patellar components (NoVac or X3 polyethylene) (cemented), Triathlon Asymmetric Patellar components (NoVac or X3 polyethylene) (cemented), Triathlon® Metal Backed Asymmetric Patellar with PA (cementless), Duracon® Symmetric & Asymmetric Patellar components (cemented), and Duracon® Inset Patella component (cemented) . These implants may also be used with ShapeMatch Cutting Guides.
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)
Non-Clinical Testing: The following non-clinical laboratory testing was performed to determine substantial equivalence: mechanical properties of the materials (ASTM F1580, ASTM F67. ASTM F136. ASTM F1147. ASTM F1044. ASTM F1160), device fatigue strength (ASTM F1800, ASTM F2083), and wear evaluation of conventional polyethylene inserts comparing subject and predicate devices (ASTM F2025, ISO 14243-3). In addition to the preceding Standards, the FDA Guidance Document entitled 'Guidance document for testing orthopaedic implants with modified metallic surfaces apposing bone or bone cement,' dated April 28, 1994, has been followed.
Clinical Testing: Clinical testing was not required as a basis for substantial equivalence.
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
§ 888.3565 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
K123486 (Page 1 of 2)
510(k) Summary
| Sponsor | Homedica Osteonics Corp.
325 Corporate Drives
Mahwah, NJ 07430 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Audrey Witko
Sr. Regulatory Affairs Specialist
1-201-831-6717 |
| Date Prepared: | November 9, 2012 |
| Proprietary Name: | Triathlon® Tritanium Tibial Baseplates |
| Common Name: | Total Knee Joint Replacement |
| Classification Name: | Knee joint Patellofemorotibial metal/polymer porous-coated
Uncemented prosthesis. (888.3565, 87MBH)
Knee joint patellofemorotibial polymer/metal/polymer semi-
constrained cemented prosthesis (888.3560, 87JWH) |
Legally Marketed Device to Which Substantial Equivalence is Claimed:
· Howmedica Osteonics Corp. - Triathlon® Total Knee System - K051380
· Zimmer, Inc. - NexGen® Trabecular Metal™ Tibial Tray - K072160
Device Description: The Triathlon Tritanium Tibial Baseplate is an extension of the Triathlon® Total Knee System product line for use in primary or revision Total Knee Arthroplasty. It is a sterile, single patient use, tibial baseplate and will be offered in the same size range as the current Triathlon® cementless baseplates (Sizes 1-8). This porous-coated baseplate is for use in both cemented and cementless applications. The Triathlon® Tritanium Tibial Baseplates are packaged with a sterile, single patient use, disposable Impactor Pad in-The Impaction Pad is to be used during the tibial baseplate impaction step only, and is to situ. be discarded once the impaction has been completed. The Impaction Pad is not for implantation.
The Triathlon® Tritanium Tibial Baseplate is compatible for use with the Triathlon® PS, CS and CR Tibial Inserts (NoVac or X3 polyethylene), Triathlon® PS and CR Femoral components (cemented & cementless), Triathlon Symmetric Patellar components (NoVac or X3 polyethylene) (cemented), Triathlon Asymmetric Patellar components (NoVac or X3 polyethylene) (cemented), Triathlon® Metal Backed Asymmetric Patellar with PA (cementless), Duracon® Symmetric & Asymmetric Patellar components (cemented), and Duracon® Inset Patella component (cemented) . These implants may also be used with ShapeMatch Cutting Guides.
Intended Use: The Triathlon® Tritanium Tibial Baseplates are designed to be implanted with or without bone cement in primary or revision Total Knee Arthroplasty procedures.
1
Indications:
General Total Knee Arthroplasty (TKR) Indications:
- · Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), theumatoid · 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) Components:
- · Ligamentous instability requiring implant bearing surface geometries with increased constraint.
- · Absent or non-functioning posterior cruciate ligament.
- · Severe anterioposterior instability of the knee joint.
The Triathlon® Tritanium Tibial Baseplates are indicated for Cemented or Cementless use.
Summary of Technologies: Device comparison showed that the proposed device is substantially equivalent in intended use, materials and performance characteristics to the predicate devices.
Non-Clinical Testing: The following non-clinical laboratory testing was performed to determine substantial equivalence: mechanical properties of the materials (ASTM F1580, ASTM F67. ASTM F136. ASTM F1147. ASTM F1044. ASTM F1160), device fatigue strength (ASTM F1800, ASTM F2083), and wear evaluation of conventional polyethylene inserts comparing subject and predicate devices (ASTM F2025, ISO 14243-3). In addition to the preceding Standards, the FDA Guidance Document entitled 'Guidance document for testing orthopaedic implants with modified metallic surfaces apposing bone or bone cement,' dated April 28, 1994, has been followed.
Clinical Testing: Clinical testing was not required as a basis for substantial equivalence.
Conclusion: The Triathlon Tibial Baseplate is substantially equivalent to the predicate devices identified in this premarket notification.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of what appears to be a caduceus, a symbol often associated with healthcare.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 3, 2013
Homedica Osteonics Corporation % Ms. Audrey Witko 325 Corporate Drive Mahwah, New Jersey 07430
Re: K123486
Trade/Device Name: Triathlon® Tritanium® Tibial Baseplates Regulation Number: 21 CFR 888.3565
Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented
prosthesis
Regulatory Class: Class II Product Code: MBH, JWH Dated: April 26, 2013 Received: April 29, 2013
Dear Ms. Witko:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 – Ms. Audrey Witko
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/3/Picture/8 description: The image shows the name "Erin I. Keith" in a stylized font. The first name, "Erin," is written in a bold, sans-serif typeface. The middle initial, "I.," and the last name, "Keith," are designed with a more decorative, outlined font. The overall design gives the name a modern and slightly artistic appearance.
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K123486
Device Name: Triathlon® Tritanium® Tibial Baseplates
Indications for Use:
General Total Knee Arthroplasty (TKR) Indications:
-
Painful, disabling joint disease of the knee resulting from: non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis), theumatoid 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 Stabilizing (PS) 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
The Triathlon® Tibial Baseplates are indicated for both cemented and uncemented use.
X ............................................................................................................................................................................ Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Elizabeth L. Frank -S
Division of Orthopedic Devices
Page 1 of 1