The LINK® Endo-Model® Knee System

K143179 · Waldemar Link GmbH & Co. KG · KRO · Jan 30, 2015 · Orthopedic

Device Facts

• Record ID: K143179
• Device Name: The LINK® Endo-Model® Knee System
• Applicant: Waldemar Link GmbH & Co. KG
• Product Code: KRO · Orthopedic
• Decision Date: Jan 30, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3510
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LINK® Endo-Model® Knee System is indicated for patients with severe joint diseases with limitation of mobility due to degenerative, rheumatoid or post-traumatic arthrosis or arthritis. Joint fractures which disallow an osteosynthetic reconstruction. This device is intended for cementless modular stem is indicated for use. The LINK® Endo-Model® Rotating Hinge and Modular Rotating Hinge Knee System are indicated for the following conditions: 1) Bone necroses. 2) Bicondylar arthrosis by partly damaged collateral ligaments 3) Revision after primary total knee replacement. 4) Revision surgery after hinge knee or rotational knee joint. 5) Revision surgery by insufficient / inadequate bone mass. 6) Arthrosis of patella flange. 7) Valgus/Varus deformities <10°. 8) Valgus/Varus deformities 10-15°. 9) Valgus/Varus deformities 15-20°. The LINK® Endo-Model® Non-Rotating Hinge and Modular Non-Rotating Hinge Knee System are indicated for the following conditions: 1) Bone necroses. 2) Bicondylar arthrosis by completely damaged ligaments and muscular instability. 3) Revision after primary total knee replacement. 4) Revision surgery after hinge knee or rotational knee joint. 5) Revision surgery by insufficient / inadequate bone mass. 6) Arthrosis of patella flange. 7) Valgus/Varus deformities <10°. 8) Valgus/Varus deformities 10-15°. 9) Valgus/Varus deformities 15-20°. 10) Valgus/Varus deformities 20-30°.

Device Story

Constrained anti-luxation total knee prosthesis; replaces damaged knee joint surfaces. System comprises femoral and tibial components, modular stems, femoral segments, and proximal tibial spacers/segments. Available in rotating and non-rotating hinge versions; modular and non-modular configurations. Operates via mechanical hinge connection; pivot point designed for physiological movement. Used by orthopedic surgeons in clinical settings for revision or complex primary arthroplasty. Provides structural stability and restores joint mobility in patients with severe bone/ligament loss. Components are cemented or cementless (modular stems). Single-use, sterile device.

Clinical Evidence

No clinical performance testing was required for this device. Substantial equivalence is supported by non-clinical bench testing.

Technological Characteristics

Materials: CoCrMo casting alloy, UHMWPE (non-crosslinked), Ti-6Al-4V. Components: Femoral/tibial, modular stems, spacers. Standards: ISO 14243-1/2 (wear), ISO 14879 (fatigue), ASTM F1800 (fatigue), ASTM F1875-98 (fretting/corrosion). Sterile, single-use. Mechanical hinge connection.

Indications for Use

Indicated for patients with severe joint disease (degenerative, rheumatoid, post-traumatic arthrosis/arthritis) or joint fractures precluding osteosynthesis. Specific indications include bone necrosis, bicondylar arthrosis with ligament damage, revision of primary total knee replacement, revision of hinge/rotational knee, revision for insufficient bone mass, patella flange arthrosis, and valgus/varus deformities up to 30°.

Regulatory Classification

Identification

A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• NexGen® Complete Knee Solution Rotating Hinge Knee (K013385)

Submission Summary (Full Text)

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

January 30, 2015

Waldenmar Link GmbH & Co. KG Dr. Thomas Mehler Director Quality Management Barkhausenweg 10 22339 Hamburg Germany

Re: K143179

Trade/Device Name: The LINK® Endo-Model® Knee System Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: Class II Product Code: KRO Dated: November 3, 2014 Received: November 4, 2014

Dear Dr. Mehler:

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

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Page 2 – Dr. Thomas Mehler

(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.

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 [phone] or [phone] 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# VincentJ. Devlin -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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# Indications for Use

510(k) Number (if known) K143179

### Device Name

The LINK® Endo-Model® Knee System

## Indications for Use (Describe)

The LINK® Endo-Model® Knee System is indicated for patients with severe joint diseases with limitation of mobility due to degenerative, rheumatoid or post-traumatic arthrosis or arthritis. Joint fractures which disallow an osteosynthetic reconstruction. This device is intended for cementless modular stem is indicated for use.

The LINK® Endo-Model® Rotating Hinge and Modular Rotating Hinge Knee System are indicated for the following conditions:

- 1) Bone necroses.
- 2) Bicondylar arthrosis by partly damaged collateral ligaments
- 3) Revision after primary total knee replacement.
- 4) Revision surgery after hinge knee or rotational knee joint.
- 5) Revision surgery by insufficient / inadequate bone mass.
- 6) Arthrosis of patella flange.
- 7) Valgus/Varus deformities <10°.
- 8) Valgus/Varus deformities 10-15°.
- 9) Valgus/Varus deformities 15-20°.

The LINK® Endo-Model® Non-Rotating Hinge and Modular Non-Rotating Hinge Knee System are indicated for the following conditions:

- 1) Bone necroses.
- 2) Bicondylar arthrosis by completely damaged ligaments and muscular instability.
- 3) Revision after primary total knee replacement.
- 4) Revision surgery after hinge knee or rotational knee joint.
- 5) Revision surgery by insufficient / inadequate bone mass.
- 6) Arthrosis of patella flange.
- 7) Valgus/Varus deformities <10°.
- 8) Valgus/Varus deformities 10-15°.
- 9) Valgus/Varus deformities 15-20°.
- 10) Valgus/Varus deformities 20-30°.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

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# 510(k) Summary

| 510(k) Submitter: | Waldemar Link GmbH & Co. KG<br>Barkhausenweg 10<br>22339 Hamburg, Germany<br>Phone: [phone]<br>Facility Registration #:3004371426 (Oststraße 4-10) |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Waldemar Link GmbH & Co. KG<br>Stefanie Reimers (Regulatory Affairs)<br>Oststraße 4-10<br>Norderstedt, GERMANY 22844<br>Phone: [phone]<br>Fax: [phone]<br>E-Mail: [e-mail] |
| Date Prepared: | November 3rd, 2014 |
| Trade Name: | LINK® Endo-Model® Knee System |
| Common Name: | Total Knee Prosthesis |
| Classification Name: | Knee joint femorotibial metal/polymer constrained cemented<br>prosthesis; 21 CFR §888.3510, product code KRO |
| Classification and Panel: | Class II, Orthopedic / 87 |
| Predicate Devices: | NexGen® Complete Knee Solution Rotating Hinge Knee,<br>manufactured by Zimmer, K013385, cleared January 9, 2002 |
| Device Description: | The LINK® Endo-Model® Knee System is constrained anti-luxation total knee prosthesis.<br>Retaining the low friction principle, the physiological movement of the rotational knee prosthesis is optimal because the pivot point is within the physiological area. Flexion and rotation of the rotational knee prosthesis take place in a cross joint.<br>The LINK® Endo-Model® Knee System consists of Femoral and Tibial Components, Modular Stems, Femoral Segments and Proximal Tibial Spacers and Segments. The modular components are interchangeable allowing for independent positioning. The Modular Stems are available in a variety of diameters and lengths in cemented or cementless version. Special Femoral Segments for revision surgery of resurfacing knee implants and for tumor cases are available in a variety of heights. Proximal Tibial Spacers and Segments are used to act as a spacer for the missing bone where surgical reasons require the removal bone. |

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The LINK® Endo-Model® Knee System is available in four (4) different knee joint versions:

- Rotating Hinge Knee Standard (Non-Modular) -Version
- Non-Rotating Hinge Knee Standard (Non-Modular) -Version
- Rotating Hinge Knee Modular Version -
- Non-Rotating Hinge Knee Modular Version -

There are two (2) different versions in the application of the knee system: Rotating and Non-Rotating Hinge version. The main design differences between the Rotating and Non-Rotating Hinge version are the two (2) different mechanical connections between the femoral and the tibial component and the consequent movement of these components. These two (2) different connections are necessary because of the different biophysical properties of the human body and the different indications and contraindications for the use of these products.

The LINK® Endo-Model® Knee System is produced of Cobalt Chromium Molybdenum casting alloy (CoCrMo) and Ultra high molecular weight polyethylene (UHMWPE / noncrosslinked). The Modular Stems (cemented) are made of Cobalt Chromium Molybdenum casting alloy (CoCrMo) materials. The Modular Stems (cementless) are made of Titanium-Aluminum-Vanadium alloy (Ti-6A1-4V) materials. Femoral Segments, Proximal Tibial Spacers and Segments are produced of Titanium-Aluminum-Vanadium alloy (Ti-6A1-4V). There are also Proximal Tibial Spacers which were made of Ultra high molecular weight polyethylene (UHMWPE / non-crosslinked). Centralizers and Patella components are made of Ultra high molecular weight polyethylene (UHMWPE / non-crosslinked). All components are sterile and for single use only.

The LINK® Endo-Model® Knee System is indicated for Indications for Use: patients with severe joint diseases with limitation of mobility due to degenerative, rheumatoid or post-traumatic arthrosis or arthritis. Joint fractures which disallow an osteosynthetic reconstruction. This device is intended for cemented use only unless a cementless modular stem is indicated for use.

> The LINK® Endo-Model® Rotating Hinge and Modular Rotating Hinge Knee System are indicated for the following conditions:

- 1) Bone necroses.

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- 2) Bicondylar arthrosis by partly damaged collateral ligaments
- Revision after primary total knee replacement. 3)
- Revision surgery after hinge knee or rotational knee joint. 4)
- Revision surgery by insufficient / inadequate bone mass. 5)
- 6) Arthrosis of patella flange.
- 7) Valgus/Varus deformities <10°.
- 8) Valgus/Varus deformities 10-15°.
- 9) Valgus/Varus deformities 15-20°.

The LINK® Endo-Model® Non-Rotating Hinge and Modular Non-Rotating Hinge Knee System are indicated for the following conditions:

- 1) Bone necroses.
- 2) Bicondylar arthrosis by completely damaged ligaments and muscular instability.
- Revision after primary total knee replacement. 3)
- 4) Revision surgery after hinge knee or rotational knee joint.
- Revision surgery by insufficient / inadequate bone mass. 5)
- Arthrosis of patella flange. 6)
- 7) Valgus/Varus deformities <10°.
- 8) Valgus/Varus deformities 10-15°.
- 9) Valgus/Varus deformities 15-20°.
- 10) Valgus/Varus deformities 20-30°.

Comparison to Predicate Device: The LINK® Endo-Model® Knee System is substantially equivalent to the commercially available device NexGen® Rotating Hinge Knee (RHK) in that both have similar indications, design (both are constrained, rotating hinge knee prostheses), materials and mechanical safety. Both devices are intended for cemented use only.

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

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

Non-clinical performance testing included: Tibial Bearing Component wear tests per ISO 14243-1 and -2; Tibial Baseplate Component fatigue tests per ISO 14879 and ASTM F1800 and Modular Connections, Fretting, and Corrosion Testing per ASTM F1875-98, Tibiafemoral and Patellofemoral contact area / stress analyses at different

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angles of flexion and Range of Motion analysis of the Endo-Model® Rotating Hinge Knee System.

Constraint testing is not applicable to a constrained prosthesis. This test was not necessary.

All Endo-Model® Rotating Hinge Knee System test samples completed the 10 million cycles Tibial Baseplate Fatigue Strength testing without evidence of fracture or cracking.

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

## Clinical Performance and Conclusions:

There was no clinical performance testing required for this device.

Conclusion: The subject LINK® Endo-Model® Knee System is substantially equivalent to the predicate devices identified in this premarket notification.

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