PNK Total Knee System

K231975 · Tjc Life Co., Ltd. · JWH · Nov 21, 2023 · Orthopedic

Device Facts

• Record ID: K231975
• Device Name: PNK Total Knee System
• Applicant: Tjc Life Co., Ltd.
• Product Code: JWH · Orthopedic
• Decision Date: Nov 21, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PNK Total Knee System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, avascular necrosis of the femoral condyle, posttraumatic loss of joint configuration. Moderate valgus, varus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. This device may also be indicated in correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure. The PNK Total Knee System is designed for cemented use only.

Device Story

Fixed-bearing total knee prosthesis; posterior stabilized (PS) or cruciate retained (CR) configurations. Components: femoral (cast cobalt-chromium-molybdenum alloy), tibial tray (Ti-6Al-4V titanium alloy), tibial insert (highly cross-linked UHMWPE), and patellar (highly cross-linked UHMWPE). PS design uses tibial posts and femoral cams for stability; CR design retains posterior cruciate ligament. Used in orthopedic surgery for total knee arthroplasty; implanted by surgeons. Provides mechanical replacement of articulating surfaces of distal femur and proximal tibia to restore joint function and reduce pain.

Clinical Evidence

Bench testing only. Performance characterized via tibial tray fatigue, constraint, contact analysis, insert disassembly, tibial insert post shear, and dislocation/jump distance/ROM testing. Biocompatibility per ISO 10993-1; sterilization validation per ISO 11137 (Gamma) and ISO 11135 (EtO); residuals per ISO 10993-7/10; endotoxin testing per ANSI/AAMI ST72:2011. HXLPE testing per ASTM F648 and F2565.

Technological Characteristics

Fixed-bearing, semi-constrained, cemented knee prosthesis. Materials: Cast CoCrMo alloy (femoral), Ti-6Al-4V alloy (tibial tray), HXLPE (insert/patella). Standards: ASTM F648, ASTM F2565, ISO 10993-1, ISO 11137, ISO 11135, ANSI/AAMI ST72:2011. PS and CR configurations. Sterile, single-use.

Indications for Use

Indicated for skeletally mature patients requiring knee arthroplasty for pain relief or improved function due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, avascular necrosis, or posttraumatic joint loss. Also indicated for moderate valgus, varus, or flexion deformity with functional ligamentous structures, and revision of failed osteotomy, arthrodesis, or prior arthroplasty. Cemented use only.

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

• Acculoc Total Knee System (K170753)
• EAUM Total Knee System (K110404)
• LOSAPA Total Knee Replacement System (K130673)
• PROLIXUS Total knee System (K170534)
• Progressive Orthopedic Total Knee System (K142649)

Submission Summary (Full Text)

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November 21, 2023

TJC Life Co., Ltd Srinu Krotha RA Specialist E1812, Dangsan, SKV1 center, 11 Yeongdengpo-gu, Seoul 07217 Republic of Korea

Re: K231975

Trade/Device Name: PNK 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: October 31, 2023 Received: November 2, 2023

Dear Srinu Krotha:

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.

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-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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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) K231975

Device Name PNK Total Knee System

#### Indications for Use (Describe)

The PNK Total Knee System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, primary and secondary traumatic arthritis, avascular necrosis of the femoral condyle, posttraumatic loss of joint configuration. Moderate valgus, varus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. This device may also be indicated in correction of unsuccessful osteotomy. arthrodesis, or failure of previous arthroplasty procedure. The PNK Total Knee System is designed for cemented use only.

Type of Use (Select one or both, as applicable):

| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|----------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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#### PNK Total Knee System

## 510(K) SUMMARY TJC Life Co., Ltd. PNK Total Knee System

## 1. ADMINISTRATIVE INFORMATION

| Manufacturer | TJC Life Co., Ltd. | |
|------------------|---------------------------------------|--|
| | E1812, Dangsan, SKV1 Center, 11 | |
| | Dangsan-ro, 41-gil, Yeongdeunngpo-gu, | |
| | Seoul, Republic of Korea, PIN: 07217 | |
| | Ph: [phone] | |
| Official Contact | SRINU Krotha | |
| | TJC Life Co., Ltd | |
| | Email: [e-mail] | |
| Date Prepared | November 21, 2023 | |

## 2. ADMINISTRATIVE INFORMATION

| Trade/Proprietary Name | PNK Total Knee System |
|------------------------|-------------------------------------------------------------------------------------------------|
| Common Name | Total Knee Joint Replacement Prosthesis |
| Regulation Number | 21CFR 888.3560 |
| Regulation Name | Knee Joint Patellofemorotibial<br>Polymer/Metal/Polymer Semi-Constrained<br>Cemented Prosthesis |
| Class | II |
| Product Codes | JWH |
| Review Panel | Orthopedics |

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#### 3. Purpose of 510(K)

The TJC Life Co., Ltd. Here by submits this traditional 510(K)

### 4. INDICATIONS

The PNK Total Knee System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, avascular necrosis of the femoral condyle, posttraumatic loss of joint configuration. Moderate valgus, varus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. This device may also be indicated in correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure. The PNK Total Knee System is designed for cemented use only.

### 5. DEVICE DESCRIPTION

The PNK Total Knee System is of the fixed bearing type with a posterior stabilized design (PS) and cruciate retained design (CR) configurations. It is a Patellofemorotibial, polymer/metal/polymer. semi-constrained, cemented knee prosthesis that consists of a femoral component, tibial tray component, tibial insert component, and patellar component.

The PS version has tibial inserts with posts and femoral components with cams that interact with the posts to help stabilize the knee after the posterior cruciate ligament is removed. The CR version has tibial inserts and femoral components without posts or cams, allowing the posterior cruciate ligament to be "retained" and provide stability to the knee joint.

Femoral Component is fabricated from cast cobalt-chromium-molybdenum alloy, and is intended for cemented application to replace the articulating surface of the distal femur. Total Knee Femoral Component is available in right and left configurations, and eight proportional sizes (sizes 1-8) to accommodate differences in patient anatomy.

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The tibial Tray components (tibial baseplate) are made from Ti-6Al-4V titanium alloy, and tibial trays are available in 8 sizes (A-H,) to allow optimal cortical bone coverage of the prepared tibia. The unique stem Diameter for the all 8 sizes.

Tibial Insert components are made from Highly Cross-linked UHMWPE (HXLPE) and are available in 12 proportional sizes that match to corresponding 2 tibial tray components and two femoral components.

Patellar components are made from Highly Cross-linked UHMWPE (HXLPE). The articulating surface of the patellar component is axisymmetric (round) with a flattened sombrero shape and the patella components are available in 6 diameters.

All implant components are provided sterile.

| Device | Manufacturer | Trade/Model<br>Name | 510(K) |
|------------------------|-----------------------------------------------|------------------------------------------------|---------|
| Primary<br>Predicate | RootLoc Co., Ltd | Acculoc Total<br>Knee System | K170753 |
| Secondary<br>Predicate | Corentec Co., Ltd | EAUM Total<br>Knee System | K110404 |
| | Corentec Co., Ltd | LOSAPA Total<br>Knee<br>Replacement<br>System | K130673 |
| | OTIS Biotech Co., Ltd | PROLIXUS<br>Total knee<br>System | K170534 |
| | The Progressive<br>Orthopedic Company,<br>LLC | Progressive<br>Orthopedic Total<br>Knee System | K142649 |

### 6. PREDICATE DEVICE

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#### 7. SUBSTANTIAL EQUIVALENCE DISCUSSION

The PNK Total Knee System is substantially equivalent in indications for use with the predicate devices. The subject device overall shape, design & material used are similar to the predicate devices. The subject device and the predicate devices encompass a similar range of physical dimensions, including the "Anterior-Posterior" and "Medial-Lateral" dimensions of the femoral and tibial tray components, the thickness of the tibial insert components and the diameter of the patella components. There are no substantial differences in technological characteristics between the two devices and as such the PNK Total Knee system introduces no different issues of safety or effectiveness.

#### 8. NONCLINICAL TESTING

All necessary testing has been performed for the worst-case PNK Total Knee system components to assure substantial equivalence to the predicate device and demonstrate the device performs as intended. All testing was performed on test units representative of finished devices. Clinical data were not needed to support the safety and effectiveness of the subject device.

The device performance was characterized through the following tests, tibial tray fatigue testing, constraint test, contact analysis, Insert disassembly test, tibial insert post shear test, and dislocation/jump distance and range of motion. Cross-linked UHMWPE testing was done as per ASTM F648 and ASTM F2565 requirements. Gamma Sterilization Validation as per ISO 11137 & Ethylene Oxide Sterilization Validation per ISO 11135 and residuals testing as per ISO 10993-7 & ISO 10993-10 were done. Bacterial Endotoxin Testing (BET) conducted as specified in ANSI/AAMI ST72:2011 and Biocompatibility testing has been done as per ISO 10993-1.

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#### PNK Total Knee System

## 9. CONCLUSION

The PNK Total Knee System is substantially equivalent to the predicate device with respect to its indications for use, design, function, and method of fixation.