Unity Total Knee System

K173884 · Corin U.S.A. Limited · JWH · Jan 17, 2018 · Orthopedic

Device Facts

• Record ID: K173884
• Device Name: Unity Total Knee System
• Applicant: Corin U.S.A. Limited
• Product Code: JWH · Orthopedic
• Decision Date: Jan 17, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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. 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 use, single use only.

Device Story

Unity Total Knee System is a fixed-bearing knee prosthesis for total knee arthroplasty. System components include cobalt chromium (CoCr) femoral component, UHMWPE tibial insert, CoCr tibial tray with titanium alloy keel, and optional all-polyethylene patellar component. Variants include cruciate retaining (CR) and posterior stabilized (PS). System includes titanium alloy augments and stem extensions for bone loss management. Used in clinical settings by orthopedic surgeons to replace damaged knee joint articulation, reduce pain, and increase mobility. Components are cemented and for single use. Output is a reconstructed knee joint articulation. Benefits include restoration of joint function and stability in patients with degenerative or traumatic knee conditions.

Clinical Evidence

No clinical data. Substantial equivalence determined via non-clinical bench testing, including torsional assembly, torsional disassembly, cyclic disassembly, and cyclic fretting per ASTM F1814-15, and cyclic testing per ASTM F1800-12. Bacterial Endotoxin Testing (BET) performed using LAL kinetic chromogenic methodology.

Technological Characteristics

Fixed-bearing knee prosthesis. Materials: Cobalt chromium alloy (femoral/tibial tray), UHMWPE (tibial insert), titanium alloy (keel/augments). Cemented fixation. Single-use. Non-clinical testing standards: ASTM F1814-15 (assembly/disassembly/fretting), ASTM F1800-12 (cyclic testing).

Indications for Use

Indicated for skeletally mature patients undergoing total knee arthroplasty due to painful, disabling joint disease (degenerative, rheumatoid, or post-traumatic arthritis), post-traumatic loss of function, moderate varus/valgus/flexion deformity, revision of unsuccessful knee replacement, or distal femur/proximal tibia fractures. Posterior stabilized variant indicated for PCL instability or absent/non-functioning PCL. Contraindicated if insufficient bone stock to support components or inadequate soft tissue stability.

Regulatory Classification

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).

Predicate Devices

• Unity™ Total Knee System (K113060)

Submission Summary (Full Text)

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January 17, 2018

Image /page/0/Picture/1 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Corin USA Limited Lorraine Mander Regulatory Affairs Associate 12750 Citrus Park Lane Tampa, Florida 33625

Re: K173884

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: December 20, 2017 Received: December 21, 2017

Dear Lorraine Mander:

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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Katherine D. Kavlock -S

for 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 SERVICES | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Food and Drug Administration | |
| <b>Indications for Use</b> | |
| Form Approved: OMB No. | 0910-0120 |
| Expiration Date: | 06/30/2020 |
| See PRA Statement below. | |
| 510(k) Number (if known) | K173884 |
| 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 use, single use only. | |
| Type of Use (Select one or both, as applicable) | <div> <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> </div> <div> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> </div> |

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FORM FDA 3881 (7/17)

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| 1. Applicant/Sponsor:<br>Distributor | Corin USA<br>12750 Citrus Park Lane<br>Suite 120<br>Tampa, Florida 33625<br>Establishment Registration No.: 1056629 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Contact Person: | Lorraine Mander<br>Regulatory Affairs Associate<br>Corin Limited<br>[phone]<br><a href="mailto:[e-mail]">[e-mail]</a><br>Lucinda Gerber<br>Global Regulatory Affairs Manager<br>Corin Limited / Corin USA<br>1 [phone]<br><a href="mailto:[e-mail]">[e-mail]</a> |
| 3. Date: | December 20, 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- constrained<br>cemented prosthesis (21CFR888.3560) |

# 3. 510(K) SUMMARY

- 8. Legally Marketed Devices to which Substantial Equivalence is claimed:
- Unity™ Total Knee System (K113060) .

# 9. Device Description:

The Unity Knee™ is a fixed bearing total knee replacement system that consists of a cobalt chromium alloy (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 total knee arthroplasty. The Unity Knee™ is provided in two variants, cruciate retaining (CR) and posterior stabilized (PS). The Unity Knee™ CR is intended for use in instances where the posterior cruciate ligament (PCL) is functional. The Unity Knee™ PS variant is utilized when a total knee replacement is indicated, and the posterior cruciate ligament is non-functioning or absent, resulting in joint instability. The

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Unity Knee™ patellar component is optional and is used in situations where replacement of the articular surface of the patella is required. The system also provides titanium alloy augments 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 femoral and tibial augments. The additional range of augments have the same intended purpose as those cleared in the original 510(k) submission (K113060).

#### 10. Intended Use / Indications:

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.

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 use, single use only.

## 11. Summary of Technologies / Substantial Equivalence:

The Unity™ Total Knee System augments, subject of this submission, are identical in terms of intended use and indications, fixation, compatible components and are manufactured from the same materials as the predicate Unity™ Total Knee augments (K113060).

Additionally, the Unity augments, the subject device, are similar to the predicate (K113606) in terms of design and size range. Based on the similarities, Corin believes that the Unity™ Total Knee System augments are substantially equivalent to the predicate devices.

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#### 12. Non-Clinical Testing:

Non-clinical testing and analysis included torsional assembly, torsional disassembly, cyclic disassembly and cyclic fretting in line with ASTM F1814-15. Cyclic testing has been conducted based on ASTM F1800-12. The results of this testing show that the Unity™ Total Knee System augment is expected to be safe and effective for the proposed indications and 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.

## 13. Clinical Testing:

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