(76 days)
No
The document describes a modified version of existing knee replacement components with changes to sterilization and manufacturing methods. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is a component of a total knee arthroplasty system, indicated for painful and disabling joint diseases, and revision surgeries, which directly addresses and treats a medical condition.
No
This device is described as a component of a total knee arthroplasty system, indicated for various knee conditions requiring surgical intervention, and its design focuses on mechanical and biological properties rather than diagnostic capabilities.
No
The device description clearly states that the device is comprised of physical components (Tibial Inserts and Patellar Components) made from UHMWPE and containing Cobalt Chromium. This indicates a hardware medical device, not a software-only one.
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 treating painful and disabling joint disease of the knee. This is a therapeutic intervention performed on the patient's body.
- Device Description: The device is described as components of a total knee system, specifically tibial inserts and patellar components made of UHMWPE. These are physical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a replacement joint.
N/A
Intended Use / Indications for Use
Indications for Use:
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.
The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented and cemented use.
The Triathlon® Total Knee System beaded and beaded with Peri-Apatite components are intended for uncemented use only.
The Triathlon® All Polyethylene tibial components are indicated for cemented use only.
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.
Indications for Bone Augments:
- Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.
- Salvage of previous unsuccessful total knee replacement or other surgical procedure, ● accompanied by bone loss.
Additional Indications for Cone Augments: - Severe degeneration or trauma requiring extensive resection and replacement ●
- Femoral and Tibial bone voids
- Metaphyseal reconstruction
The Triathlon TS Cone Augments are intended for cemented or cementless use.
Product codes
MBH, JWH
Device Description
The subject Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components are a modified version of the predicate Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components. The device designs are identical to the predicate devices which are available in the posterior stabilized (PS), cruciate retaining (CR), condylar stabilizing (CS) and total stabilizing (TS) designs for the tibial inserts, and the symmetric and asymmetric designs for the patellar components. The subject inserts and patellar components will have a different method of terminal sterilization (ethylene oxide) and will be formed by consolidating Type 1 (GUR1020) resin via conventional methods which meet the specifications of ASTM F648. Like the predicate devices, the subject Triathlon® X3® CR, CS, PS and TS+ tibial inserts will contain a Cobalt Chromium locking wire as per ASTM F90, and the Triathlon TS+ tibial insert will also additionally contain a Cobalt Chromium tibial support pin as per ASTM F1537.
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:
-
- Material Testing per ASTM F648, ASTM F2565, and Draft FDA Guidance, "Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices" (February 12, 2016).
-
- Biocompatibility Testing per ISO 10993-1:2009, ISO 10993-7:2008, and FDA Guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (June 16. 2016)
-
- Ethylene Oxide Sterilization Validation per ISO 11135:2014
-
- Wear Test based on ISO/DIS 14243-3:2014
-
- Static Shear Insert Baseplate Locking Mechanism Test
-
- Single Axis Fatigue Test
-
- Multi-Axis Fatigue Test
-
- Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72:2011 was used for pyrogenicity testing to achieve an Endotoxin limit of
§ 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
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the U.S. Food & Drug Administration logo is on the right. The FDA logo is blue and white and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".
November 16, 2017
Stryker Orthopaedics Shahrir Alam Senior Regulatory Affairs Specialist 325 Corporate Dr. Mahwah, New Jersey 07430
Re: K172634
Trade/Device Name: Triathlon®X3®UHMWPE Tibial Inserts and Patellar Components 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: August 30, 2017 Received: September 1, 2017
Dear Shahrir Alam:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K172634
Device Name: Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components
Indications for Use:
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.
The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented and cemented use.
The Triathlon® Total Knee System beaded and beaded with Peri-Apatite components are intended for uncemented use only.
The Triathlon® All Polyethylene tibial components are indicated for cemented use only.
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.
Indications for Bone Augments:
- Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.
- Salvage of previous unsuccessful total knee replacement or other surgical procedure, ● accompanied by bone loss.
3
Additional Indications for Cone Augments:
- Severe degeneration or trauma requiring extensive resection and replacement ●
- Femoral and Tibial bone voids
- Metaphyseal reconstruction
The Triathlon TS Cone Augments are intended for cemented or cementless use.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
4
510(k) Summary
| Sponsor | Stryker Orthopaedics
325 Corporate Drive
Mahwah, NJ 07430 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Shahrir Alam
Senior Regulatory Affairs Specialist
Howmedica Osteonics Corp
325 Corporate Drive
Mahwah, NJ 07430
Phone: (201) 831-6223; Fax: (201) 831-3223 |
| Alternate Contact | Margaret Klippel
Sr. Principal Regulatory Affairs Project Manager, Regulatory Affairs
Howmedica Osteonics Corp
325 Corporate Drive
Mahwah, NJ 07430
Phone: (201) 831-5559; Fax: (201)-831-4559 |
| Date Prepared: | August 31, 2017 |
| Proprietary Name: | Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components |
| Common Name: | Total Knee Joint Replacement |
| Classification Name: | Knee joint patellofemorotibial metal/polymer porous-coated
uncemented prosthesis. (888.3565)
Knee joint patellofemorotibial polymer/metal/polymer semi-
constrained cemented prosthesis (888.3560) |
| Product Codes: | MBH, IWH |
Legally Marketed Devices to Which Substantial Equivalence is Claimed:
- Triathlon® PS and CR X3® UHMWPE Tibial Inserts (K051146)
- Triathlon® Symmetric and Asymmetric X3® UHMWPE Patellar Components (K051146) ●
- Triathlon® CS X3® UHMWPE Tibial Inserts (K063423) ●
- Triathlon® TS X3® UHMWPE Tibial Inserts (K072221) o
Legally Marketed Reference Devices Used to Support Substantial Equivalence:
- Triathlon® PS Tibial Inserts (K031729) ●
- o Triathlon® Symmetric and Asymmetric Patellar Components (K040267)
- Triathlon® CR Tibial Inserts (K042883) ●
- Triathlon® CS Tibial Inserts (K063423) ●
- Triathlon® TS Tibial Inserts (K072221)
5
Device Description: The subject Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components are a modified version of the predicate Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components. The device designs are identical to the predicate devices which are available in the posterior stabilized (PS), cruciate retaining (CR), condylar stabilizing (CS) and total stabilizing (TS) designs for the tibial inserts, and the symmetric and asymmetric designs for the patellar components. The subject inserts and patellar components will have a different method of terminal sterilization (ethylene oxide) and will be formed by consolidating Type 1 (GUR1020) resin via conventional methods which meet the specifications of ASTM F648. Like the predicate devices, the subject Triathlon® X3® CR, CS, PS and TS+ tibial inserts will contain a Cobalt Chromium locking wire as per ASTM F90, and the Triathlon TS+ tibial insert will also additionally contain a Cobalt Chromium tibial support pin as per ASTM F1537.
Intended Use:
The subject devices have the same intended use as those specified in the 510(k) clearances for the predicate devices listed.
Indications for Use:
General Total Knee Arthroplasty (TKR) Indications:
- Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative o ioint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.
- Post-traumatic loss of knee joint configuration and function.
- o 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. .
- o Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture -management techniques.
The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented and cemented use.
The Triathlon® Total Knee System beaded and beaded with Peri-Apatite components are intended for uncemented use only.
The Triathlon® All Polyethylene tibial components are indicated for cemented use only.
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 ioint. ●
Additional Indications for Total Stabilizer (TS) Components:
6
- Severe instability of the knee secondary to compromised collateral ligament integrity or function.
Indications for Bone Augments:
- Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.
- o Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss.
Additional Indications for Cone Augments:
- Severe degeneration or trauma requiring extensive resection and replacement ●
- o Femoral and Tibial bone voids
- Metaphyseal reconstruction ●
The Triathlon TS Cone Augment components are intended for cemented or cementless use.
Summary of Technological Characteristics: The subject Triathlon® X3® Tibial Inserts and Patellar Components are identical in intended use, indications, design, and operational principles as the predicate device. The subject devices are different from the predicate device in its terminal sterilization method. The subject devices are terminally sterilized by Ethylene Oxide, whereas the predicate device is sterilized using Gas Plasma. Consolidation of X3® polyethylene can be performed via conventional methods. The X3® UHMWPE continues to meet the same ASTM F648 specification.
Non-Clinical Testing: The following non-clinical laboratory testing was performed to determine substantial equivalence:
-
- Material Testing per ASTM F648, ASTM F2565, and Draft FDA Guidance, "Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices" (February 12, 2016).
-
- Biocompatibility Testing per ISO 10993-1:2009, ISO 10993-7:2008, and FDA Guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (June 16. 2016)
-
- Ethylene Oxide Sterilization Validation per ISO 11135:2014
-
- Wear Test based on ISO/DIS 14243-3:2014
-
- Static Shear Insert Baseplate Locking Mechanism Test
-
- Single Axis Fatigue Test
-
- Multi-Axis Fatigue Test
-
- Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72:2011 was used for pyrogenicity testing to achieve an Endotoxin limit of