(118 days)
No
The document describes a traditional mechanical knee replacement system and its components. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is a total knee replacement system intended to provide increased mobility and reduce pain by replacing a damaged knee joint, which falls under the definition of a therapeutic device.
No
The Unity Total Knee System is an implant used for total knee arthroplasty, which is a replacement of a damaged knee joint. It is a treatment device, not one that diagnoses a condition.
No
The device description clearly states it is a fixed bearing total knee replacement system consisting of physical components like femoral components, tibial inserts, tibial trays, and patellar components. It also mentions augments and stem extensions, all of 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 devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Unity Total Knee System is a physical implant (femoral component, tibial insert, tibial tray, patellar component, augments, stem extensions) designed to replace a damaged knee joint.
- Intended Use: The intended use is to provide increased mobility and reduce pain by replacing the damaged knee joint articulation. This is a surgical intervention, not a diagnostic test performed on a specimen.
The document describes a surgical implant used in the body, not a test performed on a sample from the body.
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, single use only.
Product codes
JWH
Device Description
The Corin Unity Knee System is a fixed bearing total knee replacement system that consists of a femoral component, tibial insert, tibial tray and all-polyethylene patellar component for use in primary total knee arthroplasty. The Unity Knee System is provided in two variants, cruciate retaining (CR) and posterior stabilized (PS). The Unity CR Total Knee System is intended to accommodate the posterior cruciate ligament (PCL) if it is present. The Unity posterior stabilized variant is utilized when total knee replacement is indicated, and the posterior cruciate ligament is non-functioning or absent, resulting in joint instability. The Unity system patellar component is optional and is used in situations where replacement of the articular surface of the patella is required. The system also provides augments including femoral wedges, tibial wedges, a short keel extension and stem extensions.
The Unity Total Knee system was originally cleared in K113060. This submission is for the size of stem extension size to the range, a size 30mm in two available diameters 10mm and 14mm. Like the originally cleared stem extensions the 30mm has the same identical modular taper connection.
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 fatigue endurance and assessment of fretting properties. The results of this testing show that the Corin Unity Total Knee System stem extension is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Corin USA Limited Rachel King Regulatory Affairs Associate 5670 W Cypress Street. Suite C Tampa, Florida 33607
July 13, 2017
Re: K170808 Trade/Device Name: Unity Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: May 30, 2017 Received: May 31, 2017
Dear Rachel King:
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Indications for Use | |
| 510(k) Number ( if known ) | K170808 |
|---|---|
| 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, 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) |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------------------------------------- |
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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| FORM FDA 3881 (8/14) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
PSC Publishing Services (301) 443-6740EF
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1. 510(K) SUMMARY
| | 1. Applicant/Sponsor:
Distributor | Corin USA
12750 Citrus Park Lane
Suite 120
Tampa, FL 33625
Establishment Registration No.: 1056629 |
|--|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| | 2. Contact Person: | Lorraine Mander
Regulatory Affairs Associate
Corin Limited
+44 1285 884733
lorraine.mander@coringroup.com |
| | | |
| | | Lucinda Gerber, BA (Hons)
Global Regulatory Affairs Manager
Corin Limited / Corin USA
1 (772) 321-2478
lucinda.gerber@coringroup.com |
| | 3. Date: | March 16, 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) |
Legally Marketed Devices to which Substantial Equivalence is claimed: 8.
- Corin Unity Total Knee System (K113060) .
Device Description: 9.
The Corin Unity Knee System is a fixed bearing total knee replacement system that consists of a femoral component, tibial insert, tibial tray and all-polyethylene patellar component for use in primary total knee arthroplasty. The Unity Knee System is provided in two variants, cruciate retaining (CR) and posterior stabilized (PS). The Unity CR Total Knee System is intended to accommodate the posterior cruciate ligament (PCL) if it is present. The Unity posterior stabilized variant is utilized when total knee replacement is indicated, and the posterior cruciate ligament is non-functioning or absent, resulting in joint instability. The Unity system patellar component is optional and is used in situations where replacement of the articular surface of the patella is required. The system also provides augments including femoral wedges, tibial wedges, a short keel extension and stem extensions.
The Unity Total Knee system was originally cleared in K113060. This submission is for the size of stem extension size to the range, a size 30mm in two available diameters 10mm and 14mm. Like the originally cleared stem extensions the 30mm has the same identical modular taper connection.
4
10. Intended Use / Indications:
Intended 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.
Indications
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 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, single use only.
11. Summary of Technologies / Substantial Equivalence:
The Unity Total Knee System components, subject of this submission, are identical in terms of intended use and indications and are manufactured from the same materials as the predicate Unity Total Knee stem extensions (K113060). These components are similar to the predicates Unity Total Knee stem extensions (K113606) in terms of design. Based on these similarities, Corin believes that the Unity Total Knee System is substantially equivalent to the predicate devices.
12. Pyrogenicity Assessment:
Bacterial Endotoxin Testing (BET) has been conducted on finished, sterilised product, using Limulus Amebocyte Lystate (LAL) kinetic chromogenic methodology.
13. Non-Clinical Testing:
Non-clinical testing and analysis included fatigue endurance and assessment of fretting properties. The results of this testing show that the Corin Unity Total Knee System stem extension is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate device.
14. Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence between the Unity Total Knee System stem extension and the predicate devices.