(27 days)
Not Found
No
The summary describes a standard total knee replacement system with no mention of AI or ML technology in its intended use, device description, or performance studies.
Yes
The device is intended to treat painful, disabling joint disease of the knee by replacing the damaged knee joint articulation, which directly addresses a medical condition to restore function and alleviate symptoms.
No
The device is a total knee replacement system, intended for surgical implantation to replace a damaged knee joint, not to diagnose a condition.
No
The device description clearly outlines physical components made of cobalt chromium alloy, UHMWPE polyethylene, and titanium alloy, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for total knee arthroplasty, which is a surgical procedure to replace a damaged knee joint. This is a therapeutic intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The device is a physical implant (femoral component, tibial insert, tibial tray, patellar component, augments, stem extensions) designed to be surgically implanted into the knee joint. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
Therefore, the Unity™ Total Knee System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Unity™ Total Knee System is intended for use in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged knee joint articulation where there is evidence of sufficient sound bone to seat and support the components.
General total knee arthroplasty indications include:
• Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid 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
• Revision of previous unsuccessful knee replacement or other procedure, where soft tissue stability is adequate
• Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques
• The posterior stabilized variant is also indicated for PCL instability requiring implant bearing surface geometries with increased anterior-posterior constraint and absent or non-functioning posterior cruciate ligament
The Unity™ Total Knee System is indicated for cemented use, single use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The Unity Knee™ is a fixed bearing total knee replacement system that consists of a cobalt chromium alloy (CoCr) femoral component, a UHMWPE polyethylene tibial insert, a cobalt chromium Alloy (CoCr) tibial tray with a titanium alloy keel extension and all-polyethylene patellar component for use in primary total knee arthroplasty. The Unity Knee™ is provided in two variants, cruciate retaining (CR) and posterior stabilized (PS). The Unity Knee™ CR is intended for use in instances where the posterior cruciate ligament (PCL) is functional. The Unity Knee™ PS variant is utilized when a total knee replacement is indicated, and the posterior cruciate ligament is non-functioning or absent, resulting in joint instability. The Unity Knee™ patellar component is optional and is used in situations where replacement of the articular surface of the patella is required. The system also provides titanium alloy augments including femoral augments tibial augments and stem extensions.
The Unity Knee™ is intended for use in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged knee joint articulation where there is evidence of sufficient sound bone to seat and support the components.
The Unity™ Total Knee system was originally cleared in K113060. This submission is for the inclusion of an additional range of femoral and tibial augments. The additional range of augments have the same intended purpose as those cleared in the original 510(k) submission (K113060).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee joint
Indicated Patient Age Range
skeletally mature patients
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 analysis included torsional assembly, torsional disassembly, cyclic disassembly and cyclic fretting in line with ASTM F1814-15. Cyclic testing has been conducted based on ASTM F1800-12. The results of this testing show that the Unity™ Total Knee System augment is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate device.
Bacterial Endotoxin Testing (BET) has been conducted on finished, sterilized product, using Limulus Amebocyte Lystate (LAL) kinetic chromogenic methodology.
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
§ 888.3560 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
January 17, 2018
Image /page/0/Picture/1 description: The image shows 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.
Corin USA Limited Lorraine Mander Regulatory Affairs Associate 12750 Citrus Park Lane Tampa, Florida 33625
Re: K173884
Trade/Device Name: Unity 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 Dated: December 20, 2017 Received: December 21, 2017
Dear Lorraine Mander:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 medical devices and radiation-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,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| കുട്ടുപ്പ |
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| ਹੈ |
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
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| Food and Drug Administration | |
| Indications for Use | |
| Form Approved: OMB No. | 0910-0120 |
| Expiration Date: | 06/30/2020 |
| See PRA Statement below. | |
| 510(k) Number (if known) | K173884 |
| Device Name | Unity Total Knee System |
| Indications for Use (Describe) | The Unity™ Total Knee System is intended for use in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged knee joint articulation where there is evidence of sufficient sound bone to seat and support the components. |
| General total knee arthroplasty indications include: | |
| • Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid 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 | |
| • Revision of previous unsuccessful knee replacement or other procedure, where soft tissue stability is adequate | |
| • Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques | |
| • The posterior stabilized variant is also indicated for PCL instability requiring implant bearing surface geometries with increased anterior-posterior constraint and absent or non-functioning posterior cruciate ligament | |
| The Unity™ Total Knee System is indicated for cemented use, single use only. | |
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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FORM FDA 3881 (7/17)
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PSC Publishing Services (301) 443-6740 EF
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| 1. Applicant/Sponsor:
Distributor | Corin USA
12750 Citrus Park Lane
Suite 120
Tampa, Florida 33625
Establishment Registration No.: 1056629 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Contact Person: | Lorraine Mander
Regulatory Affairs Associate
Corin Limited
+44 1285 884761
lorraine.mander@coringroup.com
Lucinda Gerber
Global Regulatory Affairs Manager
Corin Limited / Corin USA
1 (772) 321-2478
lucinda.gerber@coringroup.com |
| 3. Date: | December 20, 2017 |
| 4. Proprietary Name: | Unity™ Total Knee System |
| 5. Common Name: | Knee Prosthesis |
| 6. Product Code(s): | JWH |
| 7. Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer semi- constrained
cemented prosthesis (21CFR888.3560) |
3. 510(K) SUMMARY
-
- Legally Marketed Devices to which Substantial Equivalence is claimed:
- Unity™ Total Knee System (K113060) .
9. Device Description:
The Unity Knee™ is a fixed bearing total knee replacement system that consists of a cobalt chromium alloy (CoCr) femoral component, a UHMWPE polyethylene tibial insert, a cobalt chromium Alloy (CoCr) tibial tray with a titanium alloy keel extension and all-polyethylene patellar component for use in primary total knee arthroplasty. The Unity Knee™ is provided in two variants, cruciate retaining (CR) and posterior stabilized (PS). The Unity Knee™ CR is intended for use in instances where the posterior cruciate ligament (PCL) is functional. The Unity Knee™ PS variant is utilized when a total knee replacement is indicated, and the posterior cruciate ligament is non-functioning or absent, resulting in joint instability. The
4
Unity Knee™ patellar component is optional and is used in situations where replacement of the articular surface of the patella is required. The system also provides titanium alloy augments including femoral augments tibial augments and stem extensions.
The Unity Knee™ is intended for use in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged knee joint articulation where there is evidence of sufficient sound bone to seat and support the components.
The Unity™ Total Knee system was originally cleared in K113060. This submission is for the inclusion of an additional range of femoral and tibial augments. The additional range of augments have the same intended purpose as those cleared in the original 510(k) submission (K113060).
10. Intended Use / Indications:
The Unity™ Total Knee System is intended for use in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the joint articulation where there is evidence of sufficient sound bone to seat and support the components.
General total knee arthroplasty indications include:
- . Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid 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
- . Revision of previous unsuccessful knee replacement or other procedure, where soft tissue stability is adequate
- . Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques
- The posterior stabilized variant is also indicated for PCL instability requiring implant bearing . surface geometries with increased anterior-posterior constraint and absent or non-functioning posterior cruciate ligament
The Unity™ Total Knee System is indicated for cemented use, single use only.
11. Summary of Technologies / Substantial Equivalence:
The Unity™ Total Knee System augments, subject of this submission, are identical in terms of intended use and indications, fixation, compatible components and are manufactured from the same materials as the predicate Unity™ Total Knee augments (K113060).
Additionally, the Unity augments, the subject device, are similar to the predicate (K113606) in terms of design and size range. Based on the similarities, Corin believes that the Unity™ Total Knee System augments are substantially equivalent to the predicate devices.
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12. Non-Clinical Testing:
Non-clinical testing and analysis included torsional assembly, torsional disassembly, cyclic disassembly and cyclic fretting in line with ASTM F1814-15. Cyclic testing has been conducted based on ASTM F1800-12. The results of this testing show that the Unity™ Total Knee System augment is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate device.
Bacterial Endotoxin Testing (BET) has been conducted on finished, sterilized product, using Limulus Amebocyte Lystate (LAL) kinetic chromogenic methodology.
13. Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence between the Unity™ Total Knee System augment and the predicate devices.