(89 days)
Not Found
No
The document describes a mechanical knee replacement system and its components, with no mention of AI or ML technology in its design, function, or testing.
Yes.
The device is a total knee replacement system intended to treat painful, disabling joint disease of the knee, providing increased mobility and reducing damaged knee joint articulation. These indications align with the definition of a therapeutic device.
No
The device is a knee replacement system intended for surgical implantation to treat painful and disabling joint disease of the knee, not for diagnosing 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, ultra-high molecular weight polyethylene, and titanium alloy. This is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a damaged knee joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the components of a total knee replacement system, which are physical implants used in surgery.
- Performance Studies: The performance studies focus on mechanical testing, wear, and constraint, which are relevant to the function and durability of a surgical implant. There are no mentions of studies related to analyzing biological samples or diagnosing conditions.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue), providing diagnostic information, or being used in a laboratory setting.
Therefore, the Unity Knee™ PS-C Tibial Insert and the Unity Total Knee System are medical devices, specifically surgical implants, and not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Unity Knee™ PS-C Tibial Insert is intended for use in the Unity Total Knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce the damaged knee joint articulation where there is evidence of sufficient sound bone to seat and support the components.
The 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 standard fracture management techniques
- · The posterior stabilized variant is also indicated for PCL instability requiring implant bearing surface with
- increased anterior-posterior constraint and absent or non-functioning posterior cruciate ligament
The Unity Total Knee System is intended for cemented use, single use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The Unity Total Knee System is a fixed bearing total knee replacement system that consists of a cobalt chromium alloy (CoCr) femoral component, an ultra-high molecular weight polyethylene (UHMWPE) tibial insert, a 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 Total Knee System femoral component is provided in two variants, cruciate retaining (CR) and posterior stabilised (PS).
- The 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 Condylar Stabilised (CS) tibial insert where the PCL is present but is lax or non-functioning or when the PCL is absent.
- . The PS femoral component is intended for use in conjunction with the PS tibial insert where the posterior cruciate ligament is non-functioning or absent, resulting in joint instability, or in conjunction with the constrained posterior-stabilized (PS-C) tibial insert where is instability of the lateral collateral ligament and/or medial collateral ligament (LCL/MCL).
The Unity Total Knee System patellar component is optional and for use with either the CR or PS femoral variants and is intended for use where replacement of the articular surface of the patella is required. The system also provides titanium alloy augments including femoral augments, tibial augments, stem extensions and offset adapters.
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 conducted to demonstrate substantial equivalence includes:
-Constraint determination in accordance with ASTM F1223-20
-Range of motion CAD assessment in accordance with ISO 21536:2023
-Contact pressure analysis in accordance with ASTM F2083-21 and ISO 21536:2023
-Latch and post ultimate strength test
-Usability testing
The Unity Knee PS-C Tibial Insert is part of the Unity Total Knee System originally cleared in K113060. Some of the previous testing performed for the Unity Total Knee System is applicable to the Unity Knee PS-C Tibial Insert:
-Micromotion assessment
-Post fatigue test
-Wear testing
The results of the specific mechanical testing performed on the Unity Knee PS-C Tibial Insert show that the device is substantially equivalent to the predicate devices. A comparison of intended use and indications for use also demonstrated substantial equivalence.
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.
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Image /page/0/Picture/0 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 text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 26, 2024
Corin USA Limited Marine De Paoli Senior Regulatory Affairs Specialist 12750 Citrus Park Lane Tampa, Florida 33625
Re: K240875
Trade/Device Name: Unity Knee PS-C Tibial Insert Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: March 29, 2024 Received: March 29, 2024
Dear Marine De Paoli:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
2
Sincerely,
Lixin Liu -S
Lixin Liu, 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) K240875
Device Name Unity Knee PS-C Tibial Insert
Indications for Use (Describe)
The Unity Knee™ PS-C Tibial Insert is intended for use in the Unity Total Knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce the damaged knee joint articulation where there is evidence of sufficient sound bone to seat and support the components.
The 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 standard fracture management techniques
- · The posterior stabilized variant is also indicated for PCL instability requiring implant bearing surface with
- increased anterior-posterior constraint and absent or non-functioning posterior cruciate ligament
The Unity Total Knee System is intended 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) |
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Image /page/4/Picture/0 description: The image shows the logo for Corin, a company focused on connected orthopaedic insight. The word "Corin" is displayed in a bold, sans-serif font with a dark teal color. Below the company name, the words "Connected Orthopaedic Insight" are written in a smaller, lighter green font. The logo is simple and modern, conveying a sense of innovation and expertise in the field of orthopaedics.
510(k) Summary
510(k) #: K240875
Prepared on: 2024-06-26
Contact Details
| Applicant Name: | Corin USA Limited |
|---|---|
| Applicant Address: | 12750 Citrus Park Lane Tampa FL 33625 United States |
| Applicant Contact Telephone: | +33456609245 |
| Applicant Contact : | Ms. Marine De Paoli |
| Applicant Contact Email : | marine.depaoli@coringroup.com |
Device Name
| Device Trade Name: | Unity Knee PS-C Tibial Insert |
|---|---|
| Common Name: | Knee prosthesis |
| Classification Name: | Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained |
| Cemented Prosthesis | |
| Regulation Number: | 21 CFR 888.3560 |
| Product Code(s): | JWH |
Legally Marketed Predicate Devices
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K111184 | Apex PS Knee System, PS-C Insert | JWH, MBH |
| K113060 | Unity Total Knee System | JWH |
Device Description Summary
The Unity Total Knee System is a fixed bearing total knee replacement system that consists of a cobalt chromium alloy (CoCr) femoral component, an ultra-high molecular weight polyethylene (UHMWPE) tibial insert, a 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 Total Knee System femoral component is provided in two variants, cruciate retaining (CR) and posterior stabilised (PS).
- The 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 Condylar Stabilised (CS) tibial insert where the PCL is present but is lax or non-functioning or when the PCL is absent.
- . The PS femoral component is intended for use in conjunction with the PS tibial insert where the posterior cruciate ligament is non-functioning or absent, resulting in joint instability, or in conjunction with the constrained posterior-stabilized (PS-C) tibial insert where is instability of the lateral collateral ligament and/or medial collateral ligament (LCL/MCL).
The Unity Total Knee System patellar component is optional and for use with either the CR or PS femoral variants and is intended for use where replacement of the articular surface of the patella is required. The system also provides titanium alloy augments including femoral augments, tibial augments, stem extensions and offset adapters.
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Image /page/5/Picture/1 description: The image shows the logo for Corin, a company focused on connected orthopedic insight. The word "Corin" is displayed in a bold, sans-serif font with rounded edges, colored in a dark teal. Below the company name, the tagline "Connected Orthopaedic Insight" is written in a smaller, lighter green font. The logo is simple and modern, reflecting the company's focus on technology and innovation in the field of orthopedics.
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.
The Unity Total Knee system was originally cleared in K113060. This submission is for the inclusion of an additional range of Unity Knee PS-C Tibial Inserts. The additional range of tibial inserts has the same intended purpose as those cleared in the original 510(k) submission (K113060).
Intended Use/Indications for Use
The Unity Knee™ PS-C Tibial Insert is intended for use in the Unity Total Knee System, 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 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 intended for cemented use, single use only.
Indications for Use Comparison
The Unity Knee PS-C tibial insert is identical to the Apex PS-C insert (K111184) and the Unity Knee PS tibial insert (K113060) in terms of intended use. The Unity Knee PS-C tibial insert indications for use are identical to the indications for use of the Unity Knee PS tibial insert.
The Unity Knee PS-C tibial insert indications for use are similar to the indications for use of the Apex PS-C insert; they fall within the intended use of the predicate device and the differences do not alter the intended therapeutic use of the subject device nor do they affect the safety and effectiveness of the device relative to the predicate.
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Image /page/6/Picture/1 description: The image shows the logo for Corin, a company that provides connected orthopaedic insight. The word "Corin" is written in a bold, sans-serif font, with the letters in a dark teal color. Below the word "Corin" is the phrase "Connected Orthopaedic Insight" in a smaller, lighter green font. The logo is simple and modern, and it conveys the company's focus on technology and innovation in the field of orthopaedics.
Technological Comparison
The Unity Knee PS-C tibial insert is identical to the Apex PS-C insert (K111184) and the Unity Knee PS tibial insert (K113060) in terms of material.
The Unity Knee PS-C tibial insert is similar to the Apex PS-C insert in terms of design, with similar tibial insert post geometry in terms of height and width of the post and general shape. The geometry of the Unity Knee PS-C tibial insert post and condylar surface provides a similar range of flexion/extension mobility, rotational constraint and varus/valgus constraint as that provided by the post and condylar surface geometry of the Apex PS-C tibial insert.
The size range and tibial insert thickness variants of the Unity Knee PS-C tibial insert are similar to those provided by the Apex PS-C tibial insert range, covering a marginally greater range overall.
The Unity Knee PS-C tibial insert is similar to the Unity Knee PS tibial insert in terms of design with similar fixation design between the tibial insert and the tibial tray. In comparison to the predicate device, the Unity Knee PS-C tibial insert has slightly modified condyle and post geometries. The Unity Knee PS-C tibial insert provides varus/valgus constraint to enhance ioint stability. The Unity Knee PS-C tibial insert provides greater rotational constraint and greater resistance to dislocation through the post and condylar surface geometry.
The size distribution of the Unity Knee PS-C tibial insert is the same as the Unity Knee PS tibial insert. The range of thickness is similar, with the Unity Knee PS-C tibial insert available in an additional thickness.
Non-Clinical and/or Clinical Tests Summary
Non-clinical testing conducted to demonstrate substantial equivalence includes:
- -Constraint determination in accordance with ASTM F1223-20
- -Range of motion CAD assessment in accordance with ISO 21536:2023
- Contact pressure analysis in accordance with ASTM F2083-21 and ISO 21536:2023 -
- -Latch and post ultimate strength test
- Usability testing -
The Unity Knee PS-C Tibial Insert is part of the Unity Total Knee System originally cleared in K113060. Some of the previous testing performed for the Unity Total Knee System is applicable to the Unity Knee PS-C Tibial Insert:
- -Micromotion assessment
- Post fatigue test -
- -Wear testing
Conclusions
The results of the specific mechanical testing performed on the Unity Knee PS-C Tibial Insert show that the device is substantially equivalent to the predicate devices. A comparison of intended use and indications for use also demonstrated substantial equivalence.