(167 days)
Not Found
No
The summary describes a traditional mechanical knee replacement system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a total knee replacement system, which is used to treat painful and disabling joint disease by replacing the damaged knee joint articulation, thereby providing increased mobility and reducing pain. This directly aligns with the definition of a therapeutic device designed to cure, treat, prevent, or mitigate disease.
No
Explanation: The device is a total knee replacement system intended for surgical implantation, not a diagnostic tool. Its purpose is to replace damaged knee joint articulations, not to diagnose conditions.
No
The device description clearly states it is a fixed bearing total knee replacement system consisting of physical components made of Cobalt Chromium Alloy, UHMWPE polyethylene, and Titanium Alloy. It is a hardware device.
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 Unity Knee™ is a physical implant (a total knee replacement system) designed to be surgically implanted into the human body to replace a damaged knee joint.
- Intended Use: The intended use is to treat painful and disabling joint disease of the knee by replacing the damaged joint articulation. This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
The information provided clearly describes a medical device used for surgical treatment, not a diagnostic test.
N/A
Intended Use / Indications for Use
General total knee arthroplasty indications include:
- Painful, disabling joint disease of the knee resulting from: degenerative 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 Knee™ is intended 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 Allov (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 and revision total knee arthroplasty. The Unity Knee™ femoral component is provided in two variants, cruciate retaining (CR) and posterior stabilized (PS).
- . The Unity Knee™ CR femoral component is intended for use in conjunction with the CR tibial insert where the posterior cruciate ligament (PCL) is functional or in conjunction with a Unity Knee™ CS tibial insert only where the PCL is present but is lax or non-functioning or when the PCL is absent.
- The Unity Knee™ PS femoral component and tibial insert variant is indicated for use where the posterior cruciate ligament is non-functioning or absent, resulting in joint instability.
The Unity Knee™ patellar component is optional for use with either the CR or PS variant and is indicated for use where replacement of the articular surface of the patella is required. The system also provides Titanium Alloy augment components 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 Unity Knee™ CS Tibial Inserts. The additional range of Tibial Insert has 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 for the Unity Knee™ CS tibial insert includes dynamic disassociation test in line with ASTM F2723-13a, constraint test in line with ASTM F1223-14, Range of motion in line with ASTM 2083-12 and contact pressure test.
The tibial insert & fixed tibial tray assembling test, micromotion assessment & wear testing were not undertaken as the design of latching mechanism between the tibial insert is identical to that of the to that of the Unity Total Knee System (CR/PS tibial insert). Therefore, equivalency claim for the Unity Knee™ CS tibial insert.
The results of this testing show that the Corin Unity Knee™ CS Tibial 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.
Clinical testing was not necessary to determine substantial equivalence between the additional components of the Unity Knee™ CS tibial insert and the predicate devices.
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/0 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
June 4, 2019
Corin USA Limited Lucinda Gerber Global Regulatory Affairs Manager 12750 Citrus Park Lane, Suite 120 Tampa, Florida 33625
Re: K183533
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: May 2, 2019 Received: May 3, 2019
Dear Lucinda Gerber:
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.
| Peter G. | Digitally signed by Peter G. Allen -S |
|---|---|
| Allen -S | Date: 2019.06.04 13:50:39 -04'00' |
For CAPT Raquel Peat, PhD, MPH, USPHS Director OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE 2.
510(k) Number (if known): K183533
Device Name: Unity Total Knee System
Indications for Use:
General total knee arthroplasty indications include:
- Painful, disabling joint disease of the knee resulting from: degenerative 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 Knee™ is intended for cemented use, single use only.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 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)
Page 1 of 1_
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3. 510(K) SUMMARY
| 1. Applicant/Sponsor:
Distributor | Corin USA Limited
12750 Citrus Park Lane
Suite 120, Tampa, FL 33625
Establishment Registration No.: 1056629 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Contact Person: | Lucinda Gerber, BA (Hons)
Global Regulatory Affairs Manager
Corin Ltd / Corin USA
1 (772) 321-2478
lucinda.gerber@coringroup.com
Homer Trieu, BEng (Hons)
Regulatory Affairs Specialist
Corin Ltd
+44 1285 655685
Homer.Trieu@coringroup.com |
| 3. Date: | December 18, 2018 |
| 4. Proprietary Name: | Unity Total Knee System |
| 5. Common Name: | Knee Prosthesis |
| 6. Product Code(s): | JWH |
-
- Classification Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prostheses (21CFR 888.3560)
Legally Marketed Devices to which Substantial Equivalence is claimed: 8.
- Corin Unity Total Knee System (K113060) ●
- Stryker Triathlon® CS (Condylar Stabilizing) Lipped Insert (K063423) ●
9. Device Description:
The Unity Knee™ is a fixed bearing total knee replacement system that consists of a Cobalt Chromium Allov (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 and revision total knee arthroplasty. The Unity Knee™ femoral component is provided in two variants, cruciate retaining (CR) and posterior stabilized (PS).
- . The Unity Knee™ CR femoral component is intended for use in conjunction with the CR tibial insert where the posterior cruciate ligament (PCL) is functional or in conjunction with a Unity Knee™ CS tibial insert only where the PCL is present but is lax or non-functioning or when the PCL is absent.
- The Unity Knee™ PS femoral component and tibial insert variant is indicated for use where the posterior cruciate ligament is non-functioning or absent, resulting in joint instability.
The Unity Knee™ patellar component is optional for use with either the CR or PS variant and is indicated for use where replacement of the articular surface of the patella is required. The system also provides Titanium Alloy augment components 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.
4
The Unity Total Knee system was originally cleared in K113060. This submission is for the inclusion of an additional range of Unity Knee™ CS Tibial Inserts. The additional range of Tibial Insert has the same intended purpose as those cleared in the original 510(k) submission (K113060).
10. Intended Use / 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 Knee™ is intended for cemented use, single use only.
11. Summary of Technologies / Substantial Equivalence:
The Unity Knee™ CS tibial insert, subject to this submission is similar to the Stryker Triathlon® CS (Condylar Stabilizing) Lipped Insert (K063423) in terms of design, material, type of bearing, intended use and indication of use. The predicate is supplied in different variants, where the tibial insert can be made from either ultra-high molecular weight polyethylene (UHMWPE) or highly cross linked polyethylene (HXLPE). The focus of the variant selected is the fixed tibial insert made from "UHMWPE", where the Unity Knee™ CS Tibial Insert is similar to the predicate devices above.
The Unity Total Knee System (CR Tibial Insert) (K113060) is also added as a predicate device because the tibial insert material, indication of use and fixture design between the tibial tray are identical. The sizes are also similar, where both tibial inserts comes in nine (9) sizes. The difference in the sizing is the range of thickness provided with Unity Knee™ CS Tibial Insert.
Based on these similarities, the Unity Knee™ CS Tibial insert is believed to be substantially equivalent to the predicate devices.
12. Non-Clinical Testing:
Non-clinical testing and analysis for the Unity Knee™ CS tibial insert includes dynamic disassociation test in line with ASTM F2723-13a, constraint test in line with ASTM F1223-14, Range of motion in line with ASTM 2083-12 and contact pressure test.
The tibial insert & fixed tibial tray assembling test, micromotion assessment & wear testing were not undertaken as the design of latching mechanism between the tibial insert is identical to that of the to that of the Unity Total Knee System (CR/PS tibial insert). Therefore, equivalency claim for the Unity Knee™ CS tibial insert.
The results of this testing show that the Corin Unity Knee™ CS Tibial is substantially equivalent to the predicate device.
5
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 additional components of the Unity Knee™ CS tibial insert and the predicate devices.