(266 days)
No
The summary describes a range extension for a knee replacement system, focusing on material and design changes (titanium tibial baseplates, meniscal insert connection). There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is a knee replacement system intended to treat various degenerative joint diseases, functional deformities, and fractures, which directly addresses medical conditions and restores function.
No
Explanation: The device is a World Knee replacement system, which is a surgically implanted prosthetic device used to replace a damaged knee joint. Its intended use is for treatment of conditions like osteoarthritis, rheumatoid arthritis, or fractures, not for diagnosing these conditions.
No
The device description explicitly states it consists of physical components like titanium tibial baseplates and UHMWPE meniscal inserts, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this is a "World Knee replacement system," which is a physical implant designed to replace a damaged knee joint.
- Intended Use: The intended use describes the conditions for which the knee replacement is indicated (osteoarthritis, rheumatoid arthritis, etc.) and the method of fixation (cemented). This is a surgical intervention, not a diagnostic test.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, this device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The patient should be skeletally mature to receive a World Knee replacement system. 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.
- . Fractures that are unmanageable using other techniques.
The World Knee replacement system is indicated for cemented fixation with bone cement (PMMA) only.
Product codes (comma separated list FDA assigned to the subject device)
JWH, MBH
Device Description
Devices covered in this 510(K) are a range extension to previously cleared 510(K) applications for World Knee system. The range extension consists of titanium tibial baseplates for the World knee, and a change to the meniscal insert connection mechanism for the World knee. The tibial baseplate is made of Titanium available in cemented version. The World Knee meniscal inserts are available as posterior stabilized or cruciate retaining variants. Cruciate retaining meniscal inserts are available as standard or ultracongruent designs. All variants of the meniscal inserts are manufactured from UHMWPE.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
The patient should be skeletally mature to receive a World Knee replacement system.
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 World Knee system is adequate for anticipated in-vivo use. Nonclinical testing carried out on the World Knee system included:
- Modular component interlock strength testing per ASTM F1814
- . Modular component assembly testing per ASTM F1814
- Tibial plate fatigue strength testing per ASTM F1800
- . Endotoxin testing per AAMI ST72
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.
K180750, K181530, K170613, K160159, K030612, K032683
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
§ 888.3560 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 27, 2019
Signature Orthopaedics Pty Ltd. Declan Brazil Managing Director 7 Sirius Road Lane Cove, NSW 2066 Australia
Re: K190577
Trade/Device Name: World Knee Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH. MBH Dated: October 24, 2019 Received: October 28, 2019
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); 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,
For Ting Song, Ph.D. Acting 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 STATEMENT 1
Device Name: World Knee Total Knee System
Indications for Use:
The patient should be skeletally mature to receive a World Knee replacement system. 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.
- . Fractures that are unmanageable using other techniques.
The World Knee replacement system is indicated for cemented fixation with bone cement (PMMA) only.
Prescription Use: Yes (Part 29 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use: No (Part 29 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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2 510(K) SUMMARY
| Manufacturer: | Signature Orthopaedics Pty Ltd
7 Sirius Road
Lane Cove, NSW 2066
Australia |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | World Knee Total Knee System |
| Common Name: | Total 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 26th, 2019 |
| Classification: | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis (JWH, 21CFR 888.3560)
Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis (MBH) |
| Predicate Devices: | Primary Predicate: |
| | Signature Orthopaedics World Total Knee System (K180750 & K181530) Signature Orthopaedics Genius Total Knee System (K170613) |
| | Secondary Predicates: |
| | Signature Orthopaedics Active-X Knee System (K160159) Smith & Nephew Genesis II Total Knee System (K030612 & K032683) |
| | Reference Predicate: |
| | Signature Orthopaedics Pegasus Stem (K133370) |
Device Description:
Devices covered in this 510(K) are a range extension to previously cleared 510(K) applications for World Knee system. The range extension consists of titanium tibial
4
baseplates for the World knee, and a change to the meniscal insert connection mechanism for the World knee. The tibial baseplate is made of Titanium available in cemented version. The World Knee meniscal inserts are available as posterior stabilized or cruciate retaining variants. Cruciate retaining meniscal inserts are available as standard or ultracongruent designs. All variants of the meniscal inserts are manufactured from UHMWPE.
Indications for Use:
The patient should be skeletally mature to receive a World Knee replacement system. 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.
- Fractures that are unmanageable using other techniques.
The World Knee replacement system is indicated for cemented fixation with bone cement (PMMA) only.
Performance Testing:
Non-clinical testing and engineering evaluations were conducted to verify that the performance of the World Knee system is adequate for anticipated in-vivo use. Nonclinical testing carried out on the World Knee system included:
- Modular component interlock strength testing per ASTM F1814
- . Modular component assembly testing per ASTM F1814
- Tibial plate fatigue strength testing per ASTM F1800
- . Endotoxin testing per AAMI ST72
Substantial Equivalence:
The Signature Orthopaedics World Knee System has the same intended use, indications for use, materials and similar design features to the predicate devices. Non-clinical testing results support the substantial equivalence claim.
Comparison of technological characteristics
The World Knee System design is similar to Signature Orthopaedics World Knee Systems (K180750 & K181530). The World Knee tibial plate material is similar to Smith & Nephew Genesis II Total Knee System (K030612 & K032683). The World Knee Meniscal insert material is the same as Signature Orthopaedics Genius Knee System (K170613), Signature Orthopaedics Active-X Knee System (K160159) and Smith & Nephew Genesis II Total Knee System (K030612 & K032683).
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Conclusions:
Technical comparison of the subject and predicate devices demonstrates equivalence in device design, intended use, indications for use and material. Non-clinical data support the safety and effectiveness of the Signature Orthopaedics World Knee Total Knee System.