The MobileLink Acetabular Cup System is indicated for patients with mobility-limiting diseases, fractures, or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures.

Indications:

1. Primary and secondary osteoarthritis
1. Rheumatoid arthritis
1. Correction of functional deformities
1. Avascular necrosis
1. Femoral neck fractures
1. Revision after implant loosening dependent on bone mass and quality

The MobileLink Dual Mobility Insert is additionally indicated for:
7) Dislocation risks

Additional indications specific to the TrabecuLink Augments:
Primary or revision surgery for hip replacement as a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.

The MobileLink Acetabular Shells are intended for cementless fixation. The TrabecuLink Augments are intended for cementless fixation to the bone and for cemented fixation to the mating shell.

Device Description

The MobileLink Acetabular Cup System is a versatile cup system, designed to provide several options for surgeons and patients within one system. This 510k adds several system components to the MobileLink Acetabular Cup System previously cleared in K182321, K192559, K200607, and K222066.

X-LINKed Inserts: The X-LINKed Inserts are manufactured from highly crosslinked polyethylene material. The inserts are available in the same sizes and designs as the previously cleared E-Dur inserts (K182321). The design variants include a neutral variant with or without offset, a shouldered variant with or without offset and 10° and 20° inclining variants with an offset. The inserts are fixed using a clamping system consisting of a combination of snap mechanism and conical clamping. Notches (tabs/recesses) at the rim further contribute to the rotational stability of the PE inserts.

TrabecuLink Augments: The TrabecuLink Metal Acetabular Augments are wedgeshaped components that conform to the shape of the acetabular shell. They are additively manufactured Ti6A14V alloy per ISO 5832-3 (chemistry and mechanical properties) and feature a porous structure (TrabecuLink) on the bone interfacing surface. They mate with the same MobileLink (TrabecuLink) Shells as previously cleared in K182321 and K222066 and they can be used with the same 6.5mm diameter bone screws cleared in K192559, or with new smaller diameter (4.5mm) bone screws introduced in this submission.

Bone Screws: The MobileLink Bone Screws are Ø 4.5mm in lengths from 15 -60mm (by 5mm increments). They feature the same head size/design as the previously cleared Ø 6.5mm screws and are made of the same wrought Ti6A14V alloy per ISO 5832-3 and ASTM F136 as the previously cleared Ø 6.5mm screws.

AI/ML Overview

This document is a 510(k) Premarket Notification from Waldemar Link GmbH & Co. KG for their MobileLink Acetabular Cup System - Line Extension (Multiple). It's a submission to the FDA regarding new components for an existing hip replacement system.

The document does not describe a study involving acceptance criteria for a device's performance in a diagnostic or AI context. Instead, it is a regulatory filing for a medical device (hip replacement components). The "performance testing" section refers to non-clinical tests to ensure the mechanical and material integrity of the new components are comparable to existing, cleared devices.

Therefore, most of the requested information regarding acceptance criteria, sample sizes for test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone algorithm performance cannot be extracted from this document, as it is not relevant to the type of device or study described.

Here's an attempt to fill in the table and address the relevant points based on the provided text, while noting where information is not applicable or available:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Non-clinical Performance Testing: Demonstrate that the device is as safe and effective as the predicate device.	Acetabular construct disassembly testing: (Push-out, lever-out, torque out for the acetabular modular connections) - Results demonstrate substantial equivalence.
	Range of Motion evaluation: (comparison to predicate) - Results demonstrate substantial equivalence.
	Wear: (rationale based on material properties and design similarity) - Results demonstrate substantial equivalence.
	Impingement testing: - Results demonstrate substantial equivalence.
	Shell/Augment construct fatigue testing: - Results demonstrate substantial equivalence.
	Bone screw testing per ASTM F543: - Results demonstrate substantial equivalence.
	Characterization of the TrabecuLink porous surface: - Results demonstrate substantial equivalence.
	Biocompatibility evaluation: - Results demonstrate substantial equivalence.

1. A table of acceptance criteria and the reported device performance:
See the table above. The acceptance criteria essentially boil down to demonstrating "substantial equivalence" to predicate devices through various non-clinical performance tests. The reported performance for each test is that "The results... demonstrate that the device is as safe and effective as the predicate device, and therefore Substantially Equivalent." Specific numerical thresholds for acceptance are not detailed in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The tests are non-clinical, likely bench testing on prototypes or manufactured samples, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This is a non-clinical device performance study, not a diagnostic study requiring expert ground truth for interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is a non-clinical device performance study, not a diagnostic study requiring adjudication.

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. This is not an AI/Software device, nor is it a diagnostic device where MRMC studies would be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/Software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the non-clinical performance tests, the "ground truth" would be the established engineering standards, material specifications (e.g., ISO 5832-3, ASTM F136, ASTM F543), and the performance characteristics of the predicate devices. The new components are tested to meet these established benchmarks.

8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device.

9. How the ground truth for the training set was established:
Not applicable. This is not a machine learning or AI device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

November 8, 2024

Waldemar Link GmbH & Co. KG % Luisa Moncada Senior Regulatory Affairs Specialist LinkBio Corp 69 King Street Dover, New Jersey 07801

Re: K241636

Trade/Device Name: MobileLink Acetabular Cup System - Line Extension (Multiple) Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH, LZO, MEH Dated: October 11, 2024 Received: October 11, 2024

Dear Luisa Moncada:

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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Limin Sun -S

Limin Sun, 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

Submission Number (if known)

K241636

Device Name

MobileLink Acetabular Cup System - Line Extension (Multiple)

Indications for Use (Describe)

Indications:

1. Primary and secondary osteoarthritis
1. Rheumatoid arthritis
1. Correction of functional deformities
1. Avascular necrosis
1. Femoral neck fractures
1. Revision after implant loosening dependent on bone mass and quality

The MobileLink Dual Mobility Insert is additionally indicated for:

Dislocation risks

Additional indications specific to the TrabecuLink Augments:

Primary or revision surgery for hip replacement as a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.

The MobileLink Acetabular Shells are intended for cementless fixation. The TrabecuLink Augments are intended for cementless fixation to the bone and for cemented fixation to the mating shell.

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)Submitter:	Waldemar Link GmbH & Co. KGBarkhausenweg 1022339 Hamburg, GermanyPhone: +49-40-539950Facility Registration: 3003386935
Contact Person:	Waldemar Link GmbH & Co. KGStefanie Fuchs (Regulatory Affairs)Oststraße 4-1022844 Norderstedt, GermanyPhone: +49-40 53995-530Fax: +49-40 53995-174E-Mail: st.fuchs@link-ortho.com
Date Prepared:	November 8, 2024
Trade Name:	MobileLink Acetabular Cup System - Line Extension (Multiple)
Common Name:	Total hip replacement system
ClassificationName:	Hip joint metal/polymer/metal semi-constrained porous-coateduncementedprosthesis. 21 CFR §888.3358, product code LPH, LZO, and MEH
Classificationand Panel:	Class II, Orthopedic / 87

Predicate Devices:

Subect DeviceComponents	Predicate Devices	510(k)Number
MobileLink X-LINKed Inserts	1. MobileLink Acetabular Cup System, Polyethylene liners inneutral, offset, 10° and 20° inclinations [Primary Predicate]	K182321
	2. DePuy Pinnacle AltrX Acetabular Cup LinerDePuy Orthopedics, Inc.	K062148
MobileLinkTrabecuLinkAugments	1. Trabecular Metal Acetabular AugmentsZimmer, Inc.	K061067,K042871,
	2. Restoration Acetabular Wedge AugmentsHowmedica Osteonics Corp. (Stryker)	K102019
Bone Screws	1. MobileLink Acetabular Cup System Ø 6.5mm System Bonescrews	K192559
	2. Trilogy or Trabecular Metal Acetabular Cup Ø 4.5mm Screws(Zimmer)	K021891,K934765

New Device System Components

Reason for Submission

Device The MobileLink Acetabular Cup System is a versatile cup system, designed to Description: provide several options for surgeons and patients within one system. This 510k adds several system components to the MobileLink Acetabular Cup System previously cleared in K182321, K192559, K200607, and K222066.

X-LINKed Inserts: The X-LINKed Inserts are manufactured from highly crosslinked polyethylene material. The inserts are available in the same sizes and designs as the previously cleared E-Dur inserts (K182321). The design variants include a neutral variant with or without offset, a shouldered variant with or without

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offset and 10° and 20° inclining variants with an offset. The inserts are fixed using a clamping system consisting of a combination of snap mechanism and conical clamping. Notches (tabs/recesses) at the rim further contribute to the rotational stability of the PE inserts.

Intended Use: General indications:

The MobileLink Acetabular Cup System is indicated for patients with mobilitylimiting diseases, fractures or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures.

Indications:

1. Primary and secondary osteoarthritis
1. Rheumatoid arthritis
1. Correction of functional deformities
1. Avascular necrosis
1. Femoral neck fractures
1. Revision after implant loosening dependent on bone mass and quality

The MobileLink Dual Mobility Insert is additionally indicated for:

1. Dislocation risks
  Additional indications specific to the TrabecuLink Augments:
1. Primary or revision surgery for hip replacement as a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.
  The MobileLink Acetabular Shells are intended for cementless fixation. The TrabecuLink Augments are intended for cementless fixation to the bone and for cemented fixation to the mating shell.

The subject MobileLink X-LINKed Inserts are substantially equivalent to the Comparison to previously cleared MobileLink E-Dur inserts (K182321) in terms of design, Predicate Device: intended use, manufacturing method, sterilization, and packaging. The only difference is that the subject devices are made from a highly crosslinked poly that doesn't contain Vitamin E. The crosslinked material of the subject devices is similar to the material of the AltrX device.

The subject TrabecuLink Augments serve the same purpose and are of similar wedge-shaped design as the cited predicate devices. The feature of the additive manufactured porous surface is equivalent to the predicate Zimmer augments (K042871, K061067) and Stryker augments (K102019). The subject TrabecuLink Augments differ from the predicate device Trabecular Metal Acetabular Augments from Zimmer (K042871, K061067) in that the predicate device appear to be porous

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	throughout with no solid core while the subject devices feature a solid core withporous structure at the surface.
	The subject and predicate bone screws all provide supplemental screw fixation foracetabular shells used with or without acetabular augments. There are nodifferences in intended use.
	The subject and predicate bone screws are all manufactured from Ti6Al4V alloy.The predicate Ø 6.5mm bone screws of the MobileLink Acetabular Cup Systemhave already been cleared via K192559 and are available in lengths from 15mm –80mm. The subject and predicate Zimmer Bone Screws are both available in Ø4.5mm, and lengths of 15mm – 60mm. Any minor differences in technologicalfeatures do not raise new questions of safety or effectiveness.
PerformanceTesting:	Non-clinical performance testing and analysis were provided, including:- Acetabular construct disassembly testing (Push-out, lever-out, torque outfor the acetabular modular connections)- Range of Motion evaluation (comparison to predicate)- Wear (rationale based on material properties and design similarity)- Impingement testing- Shell/Augment construct fatigue testing- Bone screw testing per ASTM F543- Characterization of the TrabecuLink porous surface- Biocompatibility evaluationThe results of non-clinical performance testing demonstrate that the device is assafe and effective as the predicate device, and therefore Substantially Equivalent.
Clinical Testing:	Clinical performance testing was not required to demonstrate the substantialequivalence of this device.
Conclusion:	The subject MobileLink X-LINKed Inserts and TrabecuLink Augments aresubstantially equivalent to the predicate devices identified in this premarketnotification.

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.

Acceptance Criteria and Reported Device Performance

Limin Sun -S

Indications for Use

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510(k) Summary

Predicate Devices:

Intended Use: General indications:

Indications:

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

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