LINK GEMINI SL Total Knee System

K182872 · Waldemar Link GmbH & Co. KG · JWH · Apr 3, 2019 · Orthopedic

Device Facts

• Record ID: K182872
• Device Name: LINK GEMINI SL Total Knee System
• Applicant: Waldemar Link GmbH & Co. KG
• Product Code: JWH · Orthopedic
• Decision Date: Apr 3, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LINK® GEMINI® SL® Total Knee System is indicated for patients suffering from disability due to: - Degenerative, post-traumatic or rheumatoid arthritis; - Avascular necrosis of the femoral condyle; - Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy: - Moderate valgus, varus or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts. The device is indicated for cemented use. Only cementless labeled modular stems are indicated for uncemented use.

Device Story

LINK® GEMINI® SL® Total Knee System is a semi-constrained, patellofemorotibial, cemented knee prosthesis designed to replace three articular portions of the knee joint. System includes Cruciate Retaining (CR) and Posterior Stabilized (PS) designs. Components are manufactured from CoCrMo and feature PorEx® surface modification. Device is used by orthopedic surgeons in clinical settings to restore joint function in patients with degenerative, inflammatory, or post-traumatic knee conditions. Output is a mechanical replacement of the knee joint; clinical decision-making relies on surgeon assessment of patient deformity and joint degradation. Benefits include restoration of joint configuration and mobility.

Clinical Evidence

No clinical performance testing was required for this device. Substantial equivalence is supported by non-clinical bench testing, including tibial baseplate fatigue (ISO 14879, ASTM F1800), tibial bearing wear (ISO 14243-1/2), particle analysis (ISO 17853, ASTM F1877), fretting corrosion (ASTM F1875-98), and tibial post fatigue, constraint, and range of motion analyses.

Technological Characteristics

Semi-constrained, cemented total knee prosthesis. Materials: CoCrMo with PorEx® surface modification. Design: Cruciate Retaining (CR) and Posterior Stabilized (PS) configurations. Modular stems available for cemented/cementless use. Testing standards: ISO 14879, ASTM F1800, ISO 14243-1/2, ISO 17853, ASTM F1877, ASTM F1875-98.

Indications for Use

Indicated for patients with disability due to degenerative, post-traumatic, or rheumatoid arthritis; avascular necrosis of femoral condyle; post-traumatic loss of joint configuration (patellofemoral erosion/dysfunction/prior patellectomy); or moderate valgus, varus, or flexion deformities. Also indicated for salvage of failed surgical attempts.

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

• Foundation® Knee System (K923277)
• Foundation® Posterior Stabilized Knee (K933539)
• Foundation® Knee System with TiNbN Coating (K122239)

Reference Devices

• PorEx® (K152431)
• AmorCoat™ (K122239)

Submission Summary (Full Text)

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April 3, 2019

Waldemar Link GmbH & Co. KG Andre von Malotki Regulatory Affairs Oststraße 4-10 22844 Norderstedt, Germany

Re: K182872

Trade/Device Name: LINK® GEMINI® SL® 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: March 1, 2019 Received: March 4, 2019

Dear Andre von Malotki:

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. 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 located 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-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).

Sincerelv.

Image /page/1/Picture/5 description: The image shows a digital signature. The signature is for Peter G. Allen -S. The date of the signature is 2019.04.03. The time of the signature is 23:55:12 -04'00'.

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

## Indications for Use

510(k) Number (if known)

K182872

Device Name

LINK® GEMINI® SL® Total Knee System

Indications for Use (Describe)

The LINK® GEMINI® SL® Total Knee System is indicated for patients suffering from disability due to:

- Degenerative, post-traumatic or rheumatoid arthritis;

- Avascular necrosis of the femoral condyle;

- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy:

- Moderate valgus, varus or flexion deformities.

This device may also be indicated in the salvage of previously failed surgical attempts. The device is indicated for cemented use. Only cementless labeled modular stems are indicated for uncemented use.

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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# 510(k) Summary

| 510(k)<br>Submitter: | Waldemar Link GmbH & Co. KG<br>Barkhausenweg 10<br>22339 Hamburg, Germany<br>Phone: [phone]<br>Facility Registration:3003386935 (Oststraße 4-10)<br>Facility Registration: 3007118403 (Harckesheyde 95) |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact<br>Person: | Waldemar Link GmbH & Co. KG<br>André von Malotki (Regulatory Affairs)<br>Oststraße 4-10<br>22844 Norderstedt, Germany<br>Phone: [phone]<br>Fax: [phone]<br>E-Mail: [e-mail] |
| Date<br>Prepared: | December 28th, 2018 |
| Trade Name: | LINK® GEMINI® SL® Total Knee System |
| Common<br>Name: | Total Knee Prosthesis |
| Classification<br>Name: | Knee joint patellofemorotibial polymer/metal/polymer semi-<br>constrained cemented prosthesis; 21 CFR §888.3560, product code<br>JWH |
| Classification<br>and Panel: | Class II, Orthopedic / 87 |
| Predicate<br>Devices: | Foundation® Knee System, manufactured by DJO surgical,<br>K923277, cleared 02/09/1993 |
| | Foundation® Posterior Stabilized Knee, manufactured by DJO<br>surgical, K933539, cleared 11/08/1994 |
| | Foundation® Knee System with TiNbN Coating, manufactured by<br>DJO surgical, K122239, cleared 04/11/2013 |
| Device<br>Description: | The LINK® GEMINI® SL® Total Knee System is a semi-constrained,<br>patellofemorotibial, cemented knee prosthesis. It is intended to<br>replace the three articular portions of the knee joint.<br>The system compromises two different designs: “Cruciate Retaining<br>(CR) |

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tibial components are made of CoCrMo and are available with PorEx® (K152431) surface modification.

The LINK® GEMINI® SL® Total Knee System is indicated for Indications for Use: patients suffering from disability due to:

- I Degenerative, post-traumatic or rheumatoid arthritis:
- Avascular necrosis of the femoral condyle: 트
- I Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy:
- I Moderate valgus, varus or flexion deformities.

This device may also be indicated in the salvage of previously failed surgical attempts.

The device is indicated for cemented use. Only cementless labeled modular stems are indicated for uncemented use.

The LINK® GEMINI® SL® Total Knee System is substantially Comparison equivalent to the commercially available device Foundation® Knee to Predicate Device: System, in that both have same intended use and similar indications, design, materials, technological characteristics, and principles of operation. The minor technological differences between the LINK® GEMINI® SL® Total Knee System and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the LINK® GEMINI® SL® Total Knee System is as safe and effective as the Foundation® Knee System. Both devices are intended for cemented use and contain modular stems for cemented and cementless use. The femoral and tibial components are made of CoCrMo and are available with PorEx® (K152431) surface modification. The predicate device is available with the surface modification AmorCoat™ (K122239) produced by the same manufacturer DOT GmbH with same specifications.

> Thus, the LINK® GEMINI® SL® Total Knee System is substantially equivalent.

#### Performance Non-Clinical Performance and Conclusions:

Non-Clinical performance testing was conducted with consideration Data: to Draft Guidance For The Preparation of Premarket Notifications (510(k)s) for cemented, semi-constrained Total Knee Prostheses, April 1993, Guidance Document for Knee Joint patellofemorotibial femorotibial metal/polymer porous-coated uncemented and Prostheses, January 16, 2003

> Non-clinical performance testing included: Tibial Baseplate Component fatigue test per ISO 14879 and ASTM F1800; Tibial Bearing Component wear test per ISO 14243-1 and -2; Particle Analyses test per ISO 17853 and ASTM F1877; Fretting Corrosion Testing per ASTM F1875-98; Tibial Post Fatigue Testing, Constraint

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and Range of Motion Analyses.

The results of non-clinical performance testing demonstrate that the device is as safe, as effective, and substantially equivalent to the predicate device.

# Clinical Performance and Conclusions:

There was no clinical performance testing required for this device.

- The subject device LINK® GEMINI® SL® Total Knee System is Conclusion: substantially equivalent to the predicate devices identified in this premarket notification.