(280 days)
No
The 510(k) summary describes a mechanical knee implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a knee replacement system used in partial knee arthroplasty procedures to treat degenerative or post-traumatic diseases, which directly functions to restore or replace a damaged body part, aligning with the definition of a therapeutic device.
No
This device is an implantable knee replacement system designed for surgical intervention, not for diagnosing medical conditions.
No
The device description clearly outlines physical components made of metal alloys and UHMWPE, indicating it is a hardware 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 Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the TLC Unicompartmental Knee is a surgical implant designed to replace a part of the knee joint. It is used in the body during a surgical procedure, not to test samples from the body.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, performing laboratory tests, or providing diagnostic information based on such tests.
Therefore, the TLC Unicompartmental Knee is a surgical implant/prosthetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Signature Orthopaedies' TLC Unicompartmental Knee comprising the femur component, tibial component and meniscal inserts is designed for a single compartment of the natural knee joint. The TLC Unicompartmental Knee is indicated for cemented use in partial knee arthroplasty procedures. Partial replacement of the articulating surfaces of the knee is indicated only when only one compartment of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
HSX
Device Description
The TLC Unicompartmental Knee system is a modular knee system consisting of a femoral component, meniscal insert and a tibial baseplate. The femoral component is manufactured from cast cobalt chromium alloy and are intended for use with bone cement. The tibial baseplate component is manufactured from titanium alloy and intended for use with bone cement. The meniscal insert is manufactured from UHMWPE.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint / natural knee joint
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 and engineering evaluations were conducted to verify that the performance of the TLC UniKnee system is adequate for anticipated in-vivo use. Nonclinical testing carried out on the TLC UniKnee system included:
- Range of motion analysis
- Modular component interlock strength testing .
- Component contact area and stress testing •
- Tibial plate fatigue testing .
- Modular Component Assembly Testing .
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.
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
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
June 16, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
Signature Orthopaedics Pty Ltd. Declan Brazil Managing Director 7 Sirius Road Lane Cove, NSW 2066 AUSTRALIA
Re: K212870
Trade/Device Name: TLC Unicompartmental Knee System Regulation Number: 21 CFR 888.3520 Regulation Name: Knee Joint Femorotibial Metal/Polymer Non-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSX Dated: April 27, 2022 Received: May 16, 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 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) for
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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, Ph.D. 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) K212870
Device Name
TLC Unicompartmental Knee System
Indications for Use (Describe)
The Signature Orthopaedies' TLC Unicompartmental Knee comprising the femur component, tibial component and meniscal inserts is designed for a single compartment of the natural knee joint. The TLC Unicompartmental Knee is indicated for cemented use in partial knee arthroplasty procedures. Partial replacement of the articulating surfaces of the knee is indicated only when only one compartment of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.
| Type of Use (Select one or both, as applicable) |
|---|
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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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: | TLC Unicompartmental Knee System |
| Common Name: | Unicompartmental Knee Prosthesis |
| 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: | November 3rd,2021 |
| Classification: | Knee joint femorotibial metal/polymer non-constrained
cemented prosthesis. (HSX, 21CFR 888.3520) |
| Predicate Devices: | Substantial equivalence to the following device is claimed:
• Biomet Personal Partial Knee System (K161592)
(Primary)
• Signature Orthopaedics World Total Knee Replacement |
Device Description:
The TLC Unicompartmental Knee system is a modular knee system consisting of a femoral component, meniscal insert and a tibial baseplate. The femoral component is manufactured from cast cobalt chromium alloy and are intended for use with bone cement. The tibial baseplate component is manufactured from titanium alloy and intended for use with bone cement. The meniscal insert is manufactured from UHMWPE.
System (K181530) (Reference)
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Indications for Use:
The Signature Orthopaedics' TLC Unicompartmental Knee comprising the femur component, tibial component and meniscal inserts is designed for a single compartment replacement of the natural knee joint. The TLC Unicompartmental Knee is indicated for cemented use in partial knee arthroplasty procedures. Partial replacement of the articulating surfaces of the knee is indicated only when only one compartment of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.
Summary of technological characteristics
Reconstructive partial knee joint replacement is the technological principle for the subject device At a high level, the subject and predicate devices are based on the following same technological elements:
- . The indication for use of the subject device is the same as the Biomet Persona Partial Knee System.
- . The intended surgery sites of the subject devices matches the intended surgery sites of the Biomet Persona Partial Knee System
- The subject devices are manufactured from the same materials as the predicate Biomet Persona Partial Knee System, and the World Knee Total Knee System, for femoral, meniscal, and tibial tray components
- . The subject devices are for use with cemented fixation which is in line with the Biomet Persona Partial Knee System
- . The range of sizes of the subject devices are within the range of sizes of the Biomet Persona Partial Knee System for femoral, meniscal, and tibial tray components
The following technological differences exist between the subject and predicate devices:
- The technological principle is different between the subject device and one of the predicate devices i.e. World Total Knee Replacement System.
- . Some of the design features are different between the subject and predicate devices like the highly congruent insert of the World Total Knee System.
- . Some of the femoral size variants of the subject device are not available as compared to the Biomet Persona Partial Knee System.
- . The modular locking mechanism of the tibial tray differs as compared to the Biomet Persona Partial Knee system and the World Total Knee System.
Performance Testing:
Non-clinical testing and engineering evaluations were conducted to verify that the performance of the TLC UniKnee system is adequate for anticipated in-vivo use. Nonclinical testing carried out on the TLC UniKnee system included:
- Range of motion analysis
- Modular component interlock strength testing .
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- Component contact area and stress testing •
- Tibial plate fatigue testing .
- Modular Component Assembly Testing .
Substantial Equivalence Conclusion:
The TLC Unicompartmental Knee System has the same intended use, indications for use, materials and similar design as the Biomet Persona Partial Knee System (K161592) and the World Total Knee System (K181530). Non-clinical testing results support the substantial equivalence claim. The subject devices are expected to perform adequately during clinical use.