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 sufficient sound bone to seat and support the components.

The General total knee arthroplasty indications include:

· Painful, disabling joint disease of the resulting from: degenerative arthritis, theumatoid 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.

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, a UHMWPE (Ultra-High-Molecular-Weight-Polyethylene) or ECiMa (Vitamin E enriched advanced polyethylene) tibial tray with a titanium alloy keel extension and all-polyethylene (UHMWPE) 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 or Medial Constrained (MC) tibial insert where the posterior cruciate ligament (PCL) is functional or in conjunction with a Condylar Stabilised (CS) tibial insert or MC 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.

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.

The Unity Total Knee system was originally cleared in K113060. This submission is for the inclusion of an additional range of Unity Knee MC Tibial Inserts. The additional range of tibial inserts has the same intended purpose as those cleared in the original 510(k) submission (K113060).

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for the "Unity Total Knee System." It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than on a clinical study proving device meets specific acceptance criteria in the way a de novo or PMA submission might.

However, it does outline the non-clinical tests performed to support substantial equivalence. While it doesn't present acceptance criteria and reported performance in a table with specific thresholds, it implies that the device met the requirements of the standards and analyses conducted.

Here's an attempt to structure the information based on your request, understanding that the scope of this document is a 510(k) and not a detailed clinical study report:

1. Table of Implied Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied from standards)	Reported Device Performance (Implied from "Non-Clinical and/or Clinical Tests Summary")
Conformity to ASTM F1223-20 for Constraint Determination	Constraint determination performed in accordance with ASTM F1223-20. (Implied successful)
Conformity to ISO 21536:2023 for Range of Motion	Range of motion CAD assessment performed in accordance with ISO 21536:2023. (Implied successful)
Conformity to ISO 21536:2023 for Contact Pressure	Contact pressure analysis performed in accordance with ISO 21536:2023. (Implied successful)
Conformity to ASTM F2723-21 for Dynamic Disassociation	Dynamic disassociation testing performed in accordance with ASTM F2723-21. (Implied successful)
Usability requirements met	Usability testing performed. (Implied successful)
Wear characteristics comparable to predicate	Wear assessment rationale conducted. (Implied acceptable wear characteristics)
Micromotion comparable to predicate	Micromotion assessment from original Unity Total Knee System (K113060) is applicable. (Implied successful)
Material properties comparable to predicate	Material characterization from Apex Knee ECiMa tibial insert (K201611) is applicable. (Implied successful)

2. Sample Size Used for the Test Set and Data Provenance

This document does not specify sample sizes for mechanical testing. For example, for "Constraint determination," it doesn't state how many implants were tested.

Sample Size (Test Set): Not explicitly stated for each test, but implied to be sufficient for the non-clinical tests mentioned.
Data Provenance: Not explicitly stated (e.g., country of origin), but the tests are non-clinical (laboratory-based) and not human subject data. Retrospective/Prospective is not applicable to these types of non-clinical tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The ground truth for these non-clinical tests is established by the accepted scientific and engineering principles codified in the referenced ASTM and ISO standards, and by established scientific methods, not by expert consensus on clinical cases.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical data interpretation or image annotation, not for mechanical or material testing of devices. The "judgment" for these tests comes from adherence to the test standard and engineering analysis.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. This document does not describe an MRMC comparative effectiveness study. The submission is for a 510(k) clearance based on substantial equivalence, which often relies on non-clinical performance and comparison to predicate devices rather than direct human clinical trials for effectiveness in the same way a new drug or novel device might require.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a physical medical device (total knee system), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on:

Standardized Test Methods: Adherence to established ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards (e.g., ASTM F1223-20, ISO 21536:2023, ASTM F2723-21). These standards define procedures and acceptable performance metrics.
Engineering Principles and Benchmarking: Comparison to known performance characteristics of the legally marketed predicate devices, as well as established material properties.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model or software algorithm that would require a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the reasons mentioned in point 8.

Summary

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September 23, 2024

Corin USA Limited Marine De Paoli Senior Regulatory Affairs Specialist 12750 Citrus Park Lane Tampa, Florida 33625

Re: K241570

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 Codes: JWH, OIY Dated: August 23, 2024 Received: August 23, 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.

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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 (OS) 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 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-regulatory

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assistance/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,

Image /page/2/Picture/3 description: The image shows the name "Lixin Liu -S" in a large, bold, sans-serif font. The text is black against a white background. The letters are evenly spaced and easily readable.

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) K241570

Device Name Unity Total Knee System

Indications for Use (Describe)

The General total knee arthroplasty indications include:

· Painful, disabling joint disease of the resulting from: degenerative arthritis, theumatoid 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 orthopedic insight. The word "Corin" is displayed in a bold, sans-serif font with rounded edges, and the phrase "Connected Orthopaedic Insight" is written in a smaller, lighter font below the company name. The logo is simple and modern, with a focus on clarity and readability. The colors used are a dark teal for the company name and a light green for the tagline.

510(k) Summary

510(k) #: K241570

Prepared on: 2024-09-19

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 Total Knee System
Common Name:	Knee prosthesis
Classification Name:	Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-ConstrainedCemented Prosthesis
Regulation Number:	21 CFR 888.3560
Product Code(s):	JWH, OIY

Legally Marketed Predicate Devices

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K183533	Unity Total Knee System, Unity Knee CS Tibial Insert	JWH
K113060	Unity Total Knee System, Unity Knee CR Tibial Insert	JWH
K150090	Zimmer® Persona® Personalized Knee System, MC insert	JWH, OIY, MBH

Device Description Summary

The CR femoral component is intended for use in conjunction with the CR tibial insert or Medial Constrained (MC) tibial insert where the posterior cruciate ligament (PCL) is functional or in conjunction with a Condylar Stabilised (CS) tibial insert or MC 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).

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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 logo features the company name in a bold, sans-serif font, with a dark teal color scheme. Below the name, there is a tagline in green that reads "Connected Orthopaedic Insight."

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.

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 subject Unity Total Knee System is identical to the predicate Unity Total Knee System (K183533, K113060) and Zimmer Personalized Knee System (K150090) in terms of intended use. The subject Unity Total Knee System indications for use are identical to the indications for use of the predicate Unity Total Knee System.

The Unity Total Knee System indications for use are similar to the indications for use of the Zimmer Persona Personalized Knee System; they fall within the intended use of the predicate devices 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 orthopedic insights. The word "Corin" is written in a bold, sans-serif font, with the letters in a dark teal color. Below the company name, the tagline "Connected Orthopaedic Insight" is written in a smaller, lighter green font.

Technological Comparison

The Unity Knee MC tibial insert features a high conformity on the medial condyle, similar to that of the existing Unity Knee Cruciate Sacrificing (CS) tibial insert (K183533), and a lower conformity on the lateral side, very similar to that of the existing Unity Knee Cruciate Retaining (CR) tibial insert (K113060).

Compared to the Unity Knee CS lateral condyle, the subject Unity Knee MC lateral condyle is less conforming. The Unity Knee CR medial condyle is less conforming compared to the subject Unity Knee MC medial condyle.

The Unity Knee MC tibial insert is identical to the Unity Knee CS insert and Unity Knee CR insert in terms of connected devices, footprint sizes, size range and thickness.

The Zimmer Persona Personalized Knee System Medial Congruent (MC) insert (K150090) has a similar asymmetrical tibial insert condyle shape that provides greater medial conformity and less lateral conformity.

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 ISO 21536:2023
-Dynamic disassociation testing in accordance with ASTM F2723-21
-Usability testing

A wear assessment rationale for the Unity Knee MC tibial insert was also conducted.

The Unity Knee MC tibial insert is part of the Unity Total Knee System originally cleared in K113060. The micromotion assessment performed for the Unity Total Knee System is applicable to the Unity Knee MC tibial insert.

The Unity Knee MC Tibial Insert is made of the same material as the Apex Knee ECiMa tibial insert (K201611). The material characterization performed for the ECiMa tibial insert is applicable to the Unity Knee MC tibial insert.

Conclusions

The results of the specific mechanical testing performed on the Unity Knee MC 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.

Regulation Number and Section

§ 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.