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.

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 augment components including femoral wedges, tibial wedges, a short keel extension and stem extensions with offset connections.

AI/ML Overview

The provided document describes the Unity™ Total Knee System, a medical device for knee arthroplasty. It states that "Clinical testing was not necessary to determine substantial equivalence between the Unity Total Knee System and the predicate devices." Therefore, the document does not contain information regarding acceptance criteria, reported device performance from a test set, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML-based device.

Instead, the document focuses on non-clinical testing to establish substantial equivalence to predicate devices. This type of evaluation is common for mechanical medical devices, where performance is assessed through bench testing rather than clinical trials with human subjects interacting with software.

Here's a breakdown of what the document does provide regarding the device's evaluation, as per your request related to acceptance criteria, but reinterpreted for a mechanical device:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (from ASTM F2083)	Reported Device Performance
Component function for:
- Femoral component	Expected to be safe and effective (based on testing)
- Tibial tray	Expected to be safe and effective (based on testing)
- Tibial insert	Expected to be safe and effective (based on testing)
Specific tests performed:
- Fatigue	Results support safety and effectiveness
- Endurance	Results support safety and effectiveness
- Deformation	Results support safety and effectiveness
- Contact area	Results support safety and effectiveness
- Contact pressure	Results support safety and effectiveness
- Range of motion	Results support safety and effectiveness
- Constraint	Results support safety and effectiveness
- Wear testing of UHMWPE tibial insert	Results support safety and effectiveness
- Integrity of connecting mechanisms (static and dynamic shear, bending, mechanical stop, disassociation)	Results support safety and effectiveness

Explanation: The "acceptance criteria" here are implied by adherence to industry standards, specifically ASTM F2083, which outlines specifications for total knee prostheses. The "reported device performance" is a general statement that the device met these criteria, thus deeming it "safe and effective for the proposed indications and substantially equivalent to the predicate devices."

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable in the context of clinical data for AI/ML. For mechanical bench testing, the "sample size" would refer to the number of device components tested (e.g., number of femoral components, tibial trays, inserts). This information is not specified in the provided text, but it would typically be defined within the test protocols conforming to ASTM F2083.
Data Provenance: Not applicable in the context of clinical data. The tests were performed "in accordance with ASTM F2083 Standard Specification for Total Knee Prosthesis." This implies controlled laboratory conditions for mechanical testing rather than patient data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as the evaluation was based on mechanical bench testing against engineering standards, not expert interpretation of clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable as the evaluation was based on mechanical bench testing against engineering standards, not expert adjudication of clinical findings.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This device is a mechanical total knee system, not an AI/ML diagnostic or assistive tool. Therefore, a MRMC study for AI assistance is not relevant to its evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This device is a mechanical total knee system.

7. The type of ground truth used:

Engineering Standards and Specifications: The "ground truth" for this device's performance is established by the requirements and test methods outlined in ASTM F2083 Standard Specification for Total Knee Prosthesis. Compliance with these established industry standards (e.g., specific deflection limits, fatigue life, wear rates, constraint magnitudes) serves as the basis for determining the device's mechanical integrity and functional performance.

8. The sample size for the training set:

Not applicable. This device is a mechanical knee prosthesis, not an AI/ML system that requires a "training set."

9. How the ground truth for the training set was established:

Not applicable. This device is a mechanical knee prosthesis.

Summary

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K113060

3. 510(K) SUMMARY
1. Applicant/Sponsor:	Corin USA10500 University Center DriveSuite 190Tampa, Florida 33612Establishment Registration No.: 1056629
2. Contact Person:	Lucinda GerberRegulatory Affairs AssociateCorin USA813-977-4469lucinda.gerber@coringroup.com
3. Date:	October 13, 2011
4. Proprietary Name:	Unity™ Total Knee System
5. Common Name:	Knee Prosthesis
6. Classification Name:	Knee joint patella femorotibial polymer/metal/polymer semi- constrainedcemented prosthesis (21CFR888.3560)
7. Legally Marketed Devices to which Substantial Equivalence is claimed:
	• Triathlon PS TKA System (K031729)
	• Triathlon CR TKA System (K040267)
	• Triathlon CR sz 1 Tibial Insert (K042883)
	• Triathlon PS sz 1 Tibial Insert (K050539)
	• Scorpio CR TKA System (K974556)
	• Scorpio PS TKA System (K962152)
	• Scorpio NRG System (K042343)
	• Scorpio TS (K994128)
8. 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

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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 augment components including femoral wedges, tibial wedges, a short keel extension and stem extensions with offset connections.

9. 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 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.

10. Summary of Technologies/Substantial Equivalence:

The Unity Total Knee System has the same intended use and indications and is manufactured from the same materials as the respective cruciate retaining and posterior stabilized predicates Triathlon (CR: K040267, K042883; PS: K031729, K050539) and Scorpio (CR: K974556; PS: K962152, K042343) Total Knee Systems. The range of sizes

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K113060

available for the Unity Total Knee System falls within the range cleared for the Triathlon and Scorpio devices and the Unity Total Knee System is similar to the predicate devices in regards to design. Based on these similarities, Corin believes that the Unity Total Knee System is substantially equivalent to the predicate devices.

11. Non-Clinical Testing:

Non-clinical testing and analysis are provided, including bench testing for both the cruciate retaining and the posterior stabilized designs. Testing was completed in accordance with ASTM F2083 Standard Specification for Total Knee Prosthesis and included component function for femoral, tibial tray and tibial insert (fatigue, endurance and deformation, contact area and contact pressure, range of motion, constraint). Testing also included wear testing of the UHMWPE tibial insert and integrity of connecting mechanisms for static and dynamic shear tests, bending tests, mechanical stop and disassociation. The results of this testing show that the Unity Total Knee System is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate devices.

12. Clinical Testing:

Clinical testing was not necessary to determine substantial equivalence between the Unity Total Knee System and the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol in a circular fashion. The logo is presented in black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 24, 2014

Corin, USA Ms. Lucinda Gerber, BA Regulatory Affairs Associate 10500 University Center Drive, Suite 190 Tampa, Florida 33612

Re: K113060 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: August 28, 2012 Received: August 29, 2012

Dear Ms. Gerber:

This letter corrects our substantially equivalent letter of September 10, 2012.

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

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Page 2 - Ms. Lucinda Gerber

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 (reporting of medical device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Lori A. Wiggins

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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2. INDICATIONS FOR USE

510(k) Number (if known): K113060

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, theurnatoid 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 and absent or non-functioning posterior cruciate ligament

The Unity Total Knee System is indicated for cemented, single use only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

Elizabeth L. Frank -S

Page _ 1 _ of _ 1

Division of Orthopedic Devices

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.