LINK MP RECONSTRUCTION PROSTHESIS

K142187 · Waldemar Link GmbH & Co. KG · LZO · Nov 6, 2014 · Orthopedic

Device Facts

• Record ID: K142187
• Device Name: LINK MP RECONSTRUCTION PROSTHESIS
• Applicant: Waldemar Link GmbH & Co. KG
• Product Code: LZO · Orthopedic
• Decision Date: Nov 6, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LINK® MP® Reconstruction Prosthesis is intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur. The LINK® MP® Reconstruction Hip Prosthesis is indicated for the following conditions: 1) Revision arthroplasty due to juxta-articular bone defects. 2) Revision of loosened femoral prosthesis components involving extensive bone resorption of the proximal femur and widening of the medullary cavity or marked thinning of proximal femoral cortical bone. 3) Revision of loosened femoral prosthesis components by peri- / subprosthetic fracture. 4) Deformed proximal femur due to fractures or osteotomies. 5) Correction of bone deficiencies, e.g. due to tumors. 6) Large post-revision and post-trauma segmental bone defects. The LINK® MP® Reconstruction Prosthesis is for cementless use only.

Device Story

Modular hip revision prosthesis system; components include femoral stems, neck segments, proximal spacers, and expansion bolts. Stems feature tapered design with microporous surface and longitudinal fluting for cementless fixation. Modular design allows independent positioning and adjustment of leg length. Used by orthopedic surgeons in clinical settings for complex revision hip arthroplasty. Device replaces damaged or deficient proximal femoral bone stock; restores joint function and stability. Surgeon selects appropriate stem diameter, length, and neck segment angle to match patient anatomy. Expansion bolts secure modular components. Benefits include improved structural support in patients with significant bone loss.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via non-clinical bench testing, including femoral stem fatigue (ISO 7206-4/8), femoral neck segment fatigue (ISO 7206-6), and modular connection fretting/corrosion testing (ASTM F1875-98).

Technological Characteristics

Modular hip prosthesis. Stems/neck segments: Ti-6Al-4V. Spacers/bolts: CoCrMo. Cementless fixation. Features: tapered stem, microporous surface, longitudinal fluting. Testing standards: ISO 7206-4, ISO 7206-6, ISO 7206-8, ASTM F2068, ASTM F1875-98.

Indications for Use

Indicated for revision hip arthroplasty in patients with poor bone stock or deficiencies of the femoral head, neck, or proximal femur. Conditions include juxta-articular bone defects, revision of loosened femoral components with extensive bone resorption or cortical thinning, peri-/subprosthetic fractures, deformed proximal femur (fractures/osteotomies), bone deficiencies (e.g., tumors), and large post-revision/post-trauma segmental bone defects. Cementless use only.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• LINK® MP® Reconstruction Hip (K955296)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three human profiles facing to the right.

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

November 6, 2014

Waldemar Link GmbH and Company, KG Thomas Mehler, Ph.D. Director Quality Management Barkhausenweg 10 22339 Hamburg GERMANY

Re: K142187

Trade/Device Name: LINK® MP® Reconstruction Prosthesis Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, LWJ, JDI Dated: August 4, 2014 Received: August 8, 2014

Dear Dr. Thomas 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

{1}------------------------------------------------

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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/Resourcesfor You/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 yours,

# Lori A. Wiggins -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K142187 (page 1/1)

Device Name

LINK® MP® Reconstruction Prosthesis

Indications for Use (Describe)

The LINK® MP® Reconstruction Prosthesis is intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur. The LINK® MP® Reconstruction Hip Prosthesis is indicated for the following conditions:

1) Revision arthroplasty due to juxta-articular bone defects.

2) Revision of loosened femoral prosthesis components involving extensive bone resorption of the proximal femur and widening of the medullary cavity or marked thinning of proximal femoral cortical bone.

3) Revision of loosened femoral prosthesis components by peri- / subprosthetic fracture.

- 4) Deformed proximal femur due to fractures or osteotomies.
- 5) Correction of bone deficiencies, e.g. due to tumors.
- 6) Large post-revision and post-trauma segmental bone defects.

The LINK® MP® Reconstruction Prosthesis is for cementless use only.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) N/A This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration

Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)

Page 1 of 1

PSC Publishing Services [phone] EF

{3}------------------------------------------------

# 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: | August 4th, 2014 |
| Trade Name: | LINK® MP® Reconstruction Prosthesis |
| Common Name: | Hip Revision Prosthesis |
| Classification Name: | Prosthesis Hip, Semi-Constrained, Metal/Polymer,<br>Uncemented; 21 CFR §888.3360, product code LWJ<br>Prosthesis, Hip, Semi-Constrained, Metal/Polymer,<br>Cemented; 21 CFR §888.3350, product code JDI<br>Prosthesis, Hip, Semi-Constrained, Metal / Ceramic /<br>Polymer, Cemented or Non-Porous, Uncemented; 21 CFR<br>§888.3353, product code LZO |
| Classification and Panel: | Class II, Orthopedic / 87 |
| Predicate Devices: | LINK® MP® Reconstruction Hip (K955296) |
| Device Description: | The LINK® MP® Reconstruction Prosthesis modular system<br>consists of Prosthesis Heads, Stems, Neck Segments,<br>Proximal Spacers, and Expansion Bolts. The modular<br>components are interchangeable allowing for independent<br>positioning. The Prosthesis Stems are available in a variety of<br>diameters and lengths. Neck Segments are available in a<br>variety of CCD angles and sizes. Proximal Spacers are<br>available in a variety of heights and can be used<br>independently or combined to add leg length. Expansion<br>Bolts are used to secure the Neck Segments and Proximal<br>Spacers, when used, to the modular Prosthesis Stems.<br>Additional features include a tapered stem with a. |

{4}------------------------------------------------

microporous surface. The Prosthesis Stems also include longitudinal fluting.

The MP® Reconstruction Prosthesis Stems (cementless) and Neck Segments are produced of Titanium Aluminum Vanadium alloy (Ti-6Al-4V). Proximal Spacers and Expansion Bolts are made of Cobalt Chromium Molybdenum casting alloy (CoCrMo) materials.

The LINK® MP® Reconstruction Prosthesis is intended for Indications for Use: revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck, or portions of the proximal femur. The LINK® MP® Reconstruction Hip Prosthesis is indicated for the following conditions:

- 1) Revision arthroplasty due to juxta-articular bone defects.
- 2) Revision of loosened femoral prosthesis components involving extensive bone resorption of the proximal femur and widening of the medullary cavity or marked thinning of proximal femoral cortical bone.
- Revision of loosened femoral prosthesis components by 3) peri-/subprosthetic fracture.
- 4) Deformed proximal femur due to to fractures Or osteotomies.
- 5) Correction of bone deficiencies, e.g. due to tumors.
- 6) Large post-revision and post-trauma segmental bone defects.

The LINK® MP® Reconstruction Prosthesis is for cementless use only.

Comparison to Predicate Device: The subject device has the same intended use as the predicate and uses materials identical to those used in the predicate. The design of the subject and predicate devices has the same technological characteristics except: the subject device Neck Segments are made of Ti-6Al-4V instead of CoCrMo; additional Prosthesis Stem and Neck Segment sizes and configurations have been introduced; and a hex head Expansion Bolt is used in place of the predicates Slot Head Fixation Screw.

> The performance testing is sufficient to demonstrate that the subject and predicate devices are substantially equivalent with regard to design. Any difference between the subject and predicate device does not change the intended use or fundamental scientific technology.

{5}------------------------------------------------

### Performance Data:

### Non-Clinical Performance and Conclusions:

Non-Clinical performance testing was conducted with consideration to Guidance for Industry and FDA Staff, Non-Clinical Information for Femoral Stem Prosthesis, September 17, 2007 and Guidance Document For Testing Non-Articulating,"Mechanically Locked", Components, May 1, 1995.

Non-clinical performance testing included: femoral stem fatigue tests per ISO 7206-4 and ISO 7206-8; femoral neck segment fatigue tests per ISO 7206-6; ASTM F2068; Modular Connections, Fretting, and Corrosion Testing per ASTM F1875-98.

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.