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:

Revision arthroplasty due to juxta-articular bone defects.
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 peri- / subprosthetic fracture.
Deformed proximal femur due to fractures or osteotomies.
Correction of bone deficiencies, e.g. due to tumors.
Large post-revision and post-trauma segmental bone defects.

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

Device Description

The LINK® MP® Reconstruction Prosthesis modular system consists of Prosthesis Heads, Stems, Neck Segments, Proximal Spacers, and Expansion Bolts. The modular components are interchangeable allowing for independent positioning. The Prosthesis Stems are available in a variety of diameters and lengths. Neck Segments are available in a variety of CCD angles and sizes. Proximal Spacers are available in a variety of heights and can be used independently or combined to add leg length. Expansion Bolts are used to secure the Neck Segments and Proximal Spacers, when used, to the modular Prosthesis Stems. Additional features include a tapered stem with a 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.

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA to Waldemar Link GmbH and Company, KG, regarding their LINK® MP® Reconstruction Prosthesis.

Based on the provided text, the device in question is a hip joint prosthesis, not an AI/software device. Therefore, the information typically requested for AI/software acceptance criteria and performance studies (such as sample sizes for test and training sets, expert consensus, MRMC studies, etc.) is not applicable to this medical device submission.

The document explicitly states:

"There was no clinical performance testing required for this device." (Page 5)
The performance testing conducted was non-clinical (i.e., laboratory-based, mechanical testing) to demonstrate substantial equivalence to a predicate device.

Instead of AI/software metrics, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" for this hip prosthesis are related to its mechanical performance and material characteristics, as outlined in the "Performance Data" section (Page 5).

Here's a breakdown of the relevant information provided, adapted for a mechanical device:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Standards/Tests)	Reported Device Performance and Conclusion
Guidance Considerations:
* Guidance for Industry and FDA Staff, Non-Clinical Information for Femoral Stem Prosthesis, September 17, 2007	* Non-clinical performance testing was conducted with consideration to these guidance documents.
* Guidance Document For Testing Non-Articulating,"Mechanically Locked", Components, May 1, 1995
Specific Performance Tests:
* Femoral stem fatigue tests per ISO 7206-4	* Demonstrated that the device is as safe, as effective, and substantially equivalent to the predicate devices. (Specific numerical results are not provided in this summary, but the FDA's acceptance implies satisfactory performance against the predicate).
* Femoral stem fatigue tests per ISO 7206-8	* Demonstrated that the device is as safe, as effective, and substantially equivalent to the predicate devices.
* Femoral neck segment fatigue tests per ISO 7206-6	* Demonstrated that the device is as safe, as effective, and substantially equivalent to the predicate devices.
* ASTM F2068 (presumably related to mechanical properties)	* Demonstrated that the device is as safe, as effective, and substantially equivalent to the predicate devices.
* Modular Connections, Fretting, and Corrosion Testing per ASTM F1875-98	* Demonstrated that the device is as safe, as effective, and substantially equivalent to the predicate devices.
Overall Conclusion:	The results of non-clinical performance testing demonstrated that the device is as safe, as effective, and substantially equivalent to the predicate devices. The FDA concludes that the performance testing is sufficient to demonstrate that the subject and predicate devices are substantially equivalent with regard to design.

2. Sample sized used for the test set and the data provenance:

Sample Size: Not specified in the provided text. For mechanical testing, this would typically involve a specific number of test articles (e.g., n=5 or n=10 per test condition) rather than patient data.
Data Provenance: The testing was "Non-Clinical performance testing," meaning it was conducted in a laboratory setting, not on human patients. The manufacturer is located in Hamburg, Germany.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This is a mechanical device, and "ground truth" for non-clinical testing is established by adherence to recognized international and national standards (ISO, ASTM) and FDA guidance documents. Expertise would lie in materials science, biomechanics, and engineering, and in conducting accredited laboratory tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. This is not a study involving human readers or subjective interpretations. Mechanical test results are quantitative measurements against established pass/fail criteria defined by the standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. No MRMC study was performed as this is a medical device (hip prosthesis), not an AI/software diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is a mechanical device, not an algorithm. The "standalone" performance refers to the device's mechanical integrity and functionality on its own.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Ground Truth Type: For this physical device, the "ground truth" for performance is defined by established engineering and biomechanical standards (ISO 7206 series, ASTM F1875-98, ASTM F2068) and FDA guidance documents for femoral stem prostheses. Successful performance means meeting the acceptance criteria outlined in these standards (e.g., surviving a certain number of fatigue cycles at a specified load, demonstrating acceptable wear/corrosion properties, etc.).

8. The sample size for the training set:

Not Applicable. There is no "training set" as this is not a machine learning model.

9. How the ground truth for the training set was established:

Not Applicable. There is no "training set."

In summary: The LINK® MP® Reconstruction Prosthesis underwent non-clinical, laboratory-based performance testing to demonstrate substantial equivalence to a legally marketed predicate device. The "acceptance criteria" were based on compliance with specific ISO and ASTM standards and FDA guidance documents for mechanical and material properties. No clinical studies, AI/software performance evaluations, or human reader studies were deemed necessary for this 510(k) submission.

Summary

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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

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(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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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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)

Revision arthroplasty due to juxta-articular bone defects.
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 peri- / subprosthetic fracture.

1. Deformed proximal femur due to fractures or osteotomies.
1. Correction of bone deficiencies, e.g. due to tumors.
1. 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 PRAStaff@fda.hhs.gov

"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 (301) 443-6740 EF

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510(k) Summary

510(k) Submitter:	Waldemar Link GmbH & CO. KGBarkhausenweg 1022339 Hamburg, GermanyPhone: +49-40-539950Facility Registration #:3004371426 (Oststraße 4-10)
Contact Person:	Waldemar Link GmbH & Co. KGStefanie Reimers (Regulatory Affairs)Oststraße 4-10Norderstedt, GERMANY 22844Phone: +49-40 53995-530Fax: +49-40 53995-174E-Mail: S.Reimers@linkhh.de
Date Prepared:	August 4th, 2014
Trade Name:	LINK® MP® Reconstruction Prosthesis
Common Name:	Hip Revision Prosthesis
Classification Name:	Prosthesis Hip, Semi-Constrained, Metal/Polymer,Uncemented; 21 CFR §888.3360, product code LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer,Cemented; 21 CFR §888.3350, product code JDIProsthesis, Hip, Semi-Constrained, Metal / Ceramic /Polymer, Cemented or Non-Porous, Uncemented; 21 CFR§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 systemconsists of Prosthesis Heads, Stems, Neck Segments,Proximal Spacers, and Expansion Bolts. The modularcomponents are interchangeable allowing for independentpositioning. The Prosthesis Stems are available in a variety ofdiameters and lengths. Neck Segments are available in avariety of CCD angles and sizes. Proximal Spacers areavailable in a variety of heights and can be usedindependently or combined to add leg length. ExpansionBolts are used to secure the Neck Segments and ProximalSpacers, when used, to the modular Prosthesis Stems.Additional features include a tapered stem with a.

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microporous surface. The Prosthesis Stems also include longitudinal fluting.

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.
1. 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.
1. Deformed proximal femur due to to fractures Or osteotomies.
1. Correction of bone deficiencies, e.g. due to tumors.
1. 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.

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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.

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
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.(b)
Classification. Class II.