(60 days)
No
The summary describes a mechanical knee replacement system and its components, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a knee replacement system intended to treat various degenerative joint diseases and deformities, directly addressing and alleviating a medical condition.
No
Explanation: The device described is a total knee replacement system, which is a prosthetic implant used for treatment in patients with various knee conditions, not for diagnosing them. The description focuses on its components, manufacturing materials, and non-clinical performance testing.
No
The device description clearly outlines multiple hardware components made from various materials (cobalt chrome, UHMWPE, titanium alloy) that are implanted in the body. This is a physical medical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that this is a modular total knee replacement system consisting of implants (femoral component, meniscal inserts, patella, tibial baseplate, etc.) that are surgically implanted into the patient's knee.
- Intended Use: The intended use describes the conditions for which a patient would receive a knee replacement, which is a surgical procedure to replace a damaged joint.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient.
This device is a surgical implant used to replace a damaged knee joint, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The patient should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support and accept the prosthesis.
The patient's need for knee replacement should be due to one or more of the following conditions:
- Non-inflammatory degenerative joint disease including osteoarthritis, or avascular necrosis.
- Inflammatory degenerative joint disease including rheumatoid arthritis.
- Functional deformity such as varus, valgus or flexion deformities.
- Revision procedures where other treatments or devices have failed.
Signature Orthopaedics' TriVerse Total Knee Replacement System components are indication only.
Product codes (comma separated list FDA assigned to the subject device)
JWH. OIY
Device Description
The TriVerse Total Knee System is a modular total knee replacement (TKR) system consisting of a femoral component, meniscal inserts, a locking bar for the meniscal insert, a patella and a tibial baseplate with a tibial post and bolt. The femoral component and meniscal insert locking bar is manufactured from cobalt chrome. The femoral component are available as posterior stabilise and cruciate retaining variants, while meniscal inserts are available as posterior stabilised, posterior stabilised plus, cruciate retaining and anterior stabilised variants. All variants of the meniscal inserts as well as the patella components are manufactured from Vitamin-E Stabilized UHMWPE (HXLPE). The tibial post component is available as an I-Beam or Finned keel variant. The tibial base plate, bolt and post components are manufactured from titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee
Indicated Patient Age Range
skeletally mature
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 and engineering evaluations were conducted to verify that the performance of the TriVerse Total Knee System is adequate for anticipated in-vivo use. The following non-clinical testing was carried out:
- . Range of Motion (ROM) testing
- . Tibial Tray Fatigue testing
- Tibiofemoral constraint testing ●
- Meniscal bearing interlock strength testing
- Meniscal assembly usability testing •
- . Shear Fatigue of Tibial Post testing
- Patellofemoral contact area and stress testing
Non-clinical testing results support the substantial equivalence claim. The subject devices are expected to perform adequately during clinical use.
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.
Biomet Vanguard Total Knee System (K113550)
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.
Signature Orthopaedics World Knee System (K181530), Signature Orthopaedics World Knee Total Knee System (K220737), Signature Orthopaedics Active-X Knee System (K160159)
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency name in a lighter blue. The text reads "FDA U.S. FOOD & DRUG ADMINISTRATION".
October 4, 2022
Signature Orthopaedics Pty Ltd. Declan Brazil Managing Director 7 Sirius Road Lane Cove West, NSW 2066 AUSTRALIA
Re: K222380
Trade/Device Name: TriVerse Total Knee Replacement System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH. OIY Dated: July 28, 2022 Received: August 5, 2022
Dear Declan Brazil:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ting Song, PhD Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222380
Device Name
TriVerse Total Knee Replacement System
Indications for Use (Describe)
The patient should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support and accept the prosthesis.
The patient's need for knee replacement should be due to one or more of the following conditions:
- Non-inflammatory degenerative joint disease including osteoarthritis, or avascular necrosis.
- Inflammatory degenerative joint disease including rheumatoid arthritis.
- Functional deformity such as varus, valgus or flexion deformities.
- Revision procedures where other treatments or devices have failed.
Signature Orthopaedics' TriVerse Total Knee Replacement System components are indication only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
2 510(K) SUMMARY
| Manufacturer: | Signature Orthopaedics Pty Ltd
7 Sirius Road
Lane Cove, NSW 2066
Australia |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Signature Orthopaedics Europe Ltd
Unit A, IDA Business & Technology Park Garrycastle
Athlone Westmeath N37 DY26
Ireland |
| Device Trade
Name: | TriVerse Total Knee Replacement System |
| Common Name: | TriVerse Knee |
| Contact: | Dr. Declan Brazil
Managing Director of Signature Orthopaedics |
| Prepared By: | Signature Orthopaedics Pty Ltd
7 Sirius Road
Lane Cove, NSW 2066
Australia
Phone: +61 (2) 9428 5181
Fax: +61 (2) 8456 6065 |
| Date Prepared: | 28th July 2022 |
| Classification: | Knee joint patellofemorotibial metal/polymer/metal semi-
constrained cemented prosthesis. (JWH, 21 CFR 888.3560)
Knee joint patellofemorotibial polymer+
Additive/metal/polymer + additive semi-constrained cemented
prosthesis. (OIY, 21 CFR 888.3560) |
| Predicate Devices: | Primary Predicate
Biomet Vanguard Total Knee System (K113550)
Reference Devices
Signature Orthopaedics World Knee System (K181530) Signature Orthopaedics World Knee Total Knee System (K220737) Signature Orthopaedics Active-X Knee System (K160159) |
Device Description:
The TriVerse Total Knee System is a modular total knee replacement (TKR) system consisting of a femoral component, meniscal inserts, a locking bar for the meniscal insert, a patella and a tibial baseplate with a tibial post and bolt. The femoral component
4
and meniscal insert locking bar is manufactured from cobalt chrome. The femoral component are available as posterior stabilise and cruciate retaining variants, while meniscal inserts are available as posterior stabilised, posterior stabilised plus, cruciate retaining and anterior stabilised variants. All variants of the meniscal inserts as well as the patella components are manufactured from Vitamin-E Stabilized UHMWPE (HXLPE). The tibial post component is available as an I-Beam or Finned keel variant. The tibial base plate, bolt and post components are manufactured from titanium alloy.
Indications for Use:
The patient should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support and accept the prosthesis.
The patient's need for knee replacement should be due to one or more of the following conditions:
- . Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis.
- . Inflammatory degenerative joint disease including rheumatoid arthritis.
- Functional deformity such as varus, valgus or flexion deformities.
- . Revision procedures where other treatments or devices have failed.
Signature Orthopaedics' TriVerse Total Knee replacement components are indicated for cemented application only.
Summary of Technological Characteristics:
Reconstructive total knee joint replacement is the technological principle for both the subject device and the predicate devices. The subject and primary predicate devices are based on the same technological elements as listed below.
- . The indication for use of the subject device is the same as the Biomet Vanguard Total Knee System.
- . The intended surgery sites of the subject devices matches the intended surgery sites of the Biomet Vanguard Total Knee System
- . The subject devices are manufactured from the same materials as the predicate Biomet Vanguard Total Knee System for femoral, meniscal and all components related to the tibial tray (tibial post, locking bolt) and insert locking bar.
- . The modular locking mechanism of the tibial tray with a locking bar is the same as the Biomet Vanguard Total Knee system.
- . The articulating surfaces and kinematics of the subject devices are the same as that of the Biomet Vanguard Total Knee System.
- . The design features and size ranges of the subject device are the same as that of the Biomet Vanguard Total Knee System.
Performance Testing:
Non-clinical testing and engineering evaluations were conducted to verify that the performance of the TriVerse Total Knee System is adequate for anticipated in-vivo use. The following non-clinical testing was carried out:
- . Range of Motion (ROM) testing
- . Tibial Tray Fatigue testing
- Tibiofemoral constraint testing ●
- Meniscal bearing interlock strength testing
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- Meniscal assembly usability testing •
- . Shear Fatigue of Tibial Post testing
- Patellofemoral contact area and stress testing
Substantial Equivalence Conclusion:
The TriVerse Total Knee System has the same intended use, indications for use, materials and similar design as the Biomet Vanguard Total Knee System (K113550). Non-clinical testing results support the substantial equivalence claim. The subject devices are expected to perform adequately during clinical use.