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 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.

AI/ML Overview

This document is a 510(k) summary for the Unity Total Knee System. It details the device's technical specifications and how it relates to predicate devices, but it does not contain information about the acceptance criteria or a study proving the device meets said criteria in the context of device performance metrics such as sensitivity, specificity, or accuracy.

The provided text describes a submission for an orthopedic implant (a knee replacement system), not a diagnostic or AI-driven medical device that would have performance metrics like those typically associated with acceptance criteria in the input request.

Therefore, I cannot extract the requested information from this document. The document primarily focuses on:

Device Name: Unity Total Knee System
Regulation Number: 21 CFR 888.3560
Regulatory Class: Class II
Product Code: JWH
Indications for Use: Detailed for total knee arthroplasty in skeletally mature patients to increase mobility and reduce pain by replacing the damaged knee joint.
Device Description: Discusses the components (femoral, tibial insert, tibial tray, patellar component), variants (cruciate retaining and posterior stabilized), and augments (femoral/tibial wedges, stem extensions).
Substantial Equivalence: Claims equivalence to the predicate Corin Unity Total Knee System (K113060) based on identical intended use, indications, materials, and similar design for the new stem extension size.
Non-Clinical Testing: Mentions fatigue endurance and fretting properties testing, concluding that the device is expected to be safe and effective.
Clinical Testing: Explicitly states that clinical testing was not necessary to determine substantial equivalence.

In summary, the document does not contain the information required to answer your specific questions related to acceptance criteria and performance study details for an AI/diagnostic device.

Summary

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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

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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

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See 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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1. 510(K) SUMMARY

	1. Applicant/Sponsor:Distributor	Corin USA12750 Citrus Park LaneSuite 120Tampa, FL 33625Establishment Registration No.: 1056629
	2. Contact Person:	Lorraine ManderRegulatory Affairs AssociateCorin Limited+44 1285 884733lorraine.mander@coringroup.com

		Lucinda Gerber, BA (Hons)Global Regulatory Affairs ManagerCorin Limited / Corin USA1 (772) 321-2478lucinda.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- constrainedcemented prosthesis (21CFR888.3560)

Legally Marketed Devices to which Substantial Equivalence is claimed: 8.

Corin Unity Total Knee System (K113060) .

Device Description: 9.

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10. Intended Use / Indications:

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 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.

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.