(270 days)
General Indications:
The MobileLink® Acetabular Cup System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures.
Indications:
-
- Primary and secondary osteoarthritis
-
- Rheumatoid arthritis
-
- Correction of functional deformities
-
- Avascular necrosis
-
- Femoral neck fractures
- Revision after implant loosening dependent on bone mass and quality
The MobileLink® Acetabular Cup System is a versatile cup system, designed to provide several options for surgeons and patients within one system. The cup system consists of press-fit metal shells made of a Ti6Al4V alloy. The system offers two designs, a cluster hole shell, with closing screws and a polar screw, and a multi hole shell. Both shells are available with two different coatings, either plasma sprayed coating (PlasmaLink®) or a double coating consisting of plasma spray plus calcium phosphate coating (TiCaP®). All shells are implanted cementless. The acetabular inserts are manufactured from conventional UHMWPE or Vitamin E highly crosslinked UHMWPE (E-Dur®). The inserts are available in six designs, neutral, offset, shouldered, offset/shouldered, 10° and 20° inclination. This premarket notification does not include the femoral components. The MobileLink® Acetabular Cup System is compatible with previously cleared femoral heads (K161840, K953653) and hip stems and neck segments (K161840, K151008, K142187, K953653) of Waldemar Link GmbH & Co. KG.
The provided text describes a 510(k) premarket notification for the "MobileLink Acetabular Cup System". This notification is a submission to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices, and therefore does not require a study proving the device meets specific acceptance criteria in the same way a novel device might.
Instead, the submission relies on non-clinical performance testing and analysis to demonstrate substantial equivalence to predicate devices. There is no mention of specific quantitative acceptance criteria or a dedicated study designed to prove the device meets such criteria with statistical significance.
Here's an breakdown of the information based on your request, structured to reflect what is actually present in the document:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission for substantial equivalence based on non-clinical testing, there isn't a table of specific, quantitative "acceptance criteria" for clinical performance. The "performance" is demonstrated through various bench tests and characterizations, aiming to show similarity to predicate devices.
| Test Type | Objective / "Acceptance Criteria" (Implied) | Reported Performance / Conclusion |
|---|---|---|
| Disassembly Testing (Axial push-out, offset pullout, and torsional tests according to ASTM F1820 for liner/shell assembly) | Demonstrate mechanical integrity and resistance to disassembly, comparable to predicate devices. | Results indicate the device performs adequately and maintains mechanical integrity as expected for an acetabular cup system. The device is shown to be as safe and effective as the predicate device. |
| Wear Test (according to ISO 14242-1 and particle analysis per ISO 17853 and ASTM F1877) | Demonstrate wear rates and particle generation comparable to predicate devices and acceptable for clinical use. | Wear rates were compared to those of the Stelkast Exp highly crosslinked Vitamin E UHMWPE acetabular shell liners (a reference device), suggesting comparable or acceptable wear performance. |
| Wear Testing under Adverse Conditions and Particle Analysis | Demonstrate performance under more challenging conditions, comparable to predicate devices. | Results imply acceptable wear performance under adverse conditions, consistent with predicate devices. |
| Range of Motion (according to ISO 21535) | Demonstrate an appropriate range of motion. | Results indicate the device allows for a range of motion comparable to predicate devices and clinically acceptable. |
| Endotoxin Testing | Confirm biocompatibility and sterility. | Results indicate compliance with endotoxin limits, supporting the safety of the device. |
| Impingement Testing (per ASTM F2582) | Demonstrate resistance to impingement and associated wear/damage. | Results indicate acceptable performance in impingement tests, comparable to predicate devices. |
| Coating Characterization (microstructural analysis, mechanical testing, metallurgical analysis per FDA Guidance) | Demonstrate coating integrity, adhesion, and material properties consistent with established standards and predicate devices. | Results demonstrate the coatings meet established standards and are comparable to those of predicate devices, ensuring long-term performance. |
| PE Characterization (material characterization, HXL characterization and aging study, biocompatibility testing per ISO 10993) | Demonstrate material properties, stability, and biocompatibility of the UHMWPE liners consistent with established standards and predicate devices. | Results indicate the PE materials conform to FDA guidance for UHMWPE, including HXL characterization, aging study, and biocompatibility, thereby supporting the safety and effectiveness of the device. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated in the document. The testing described is bench testing, involving mechanical specimens rather than patient data.
- Data Provenance: Not applicable in the context of clinical data. The tests are bench tests conducted in a laboratory setting for the purpose of a 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts & Qualifications: Not applicable. For bench testing, "ground truth" is typically established by engineering specifications, material standards (e.g., ASTM, ISO), and regulatory guidelines rather than expert clinical consensus.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This is not a clinical study involving human interpretation of data where adjudication would be necessary. The tests are objective measurements against engineering 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
- MRMC Study: No. This device is a physical implant (acetabular cup system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is not an algorithmic device.
7. The Type of Ground Truth Used
- Ground Truth: For bench testing, the "ground truth" refers to established engineering standards (e.g., ASTM, ISO), mechanical properties, material specifications, and performance expectations derived from predicate devices. The goal is to demonstrate that the device meets these engineering and material requirements.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is not an AI/ML device that requires a training set of data.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable. This is not an AI/ML device.
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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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
Waldemar Link GmbH & Co. KG Karen Sonnenberger Regulatory Affairs Specialist Oststrabe 4-10 Norderstedt, 22844 De
Re: K182321
Trade/Device Name: MobileLink Acetabular Cup System 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, MEH, OQG, LPH Dated: April 25, 2019 Received: April 26, 2019
Dear Karen Sonnenberger:
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
May 24, 2019
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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
FOR CAPT Raquel Peat, PhD, MPH, USPHS Director Office of Health Technology 6 Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K182321
Device Name MobileLink® Acetabular Cup System
Indications for Use (Describe)
General Indications:
The MobileLink® Acetabular Cup System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures.
Indications:
-
- Primary and secondary osteoarthritis
-
- Rheumatoid arthritis
-
- Correction of functional deformities
-
- Avascular necrosis
-
- Femoral neck fractures
- Revision after implant loosening dependent on bone mass and qualityThe shells are
| 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) Summary
| 510(k) Submitter: | Waldemar Link GmbH & Co. KGBarkhausenweg 1022339 Hamburg, GermanyPhone: +49-40-539950Facility Registration: 3003386935 (Oststraße 4-10)Facility Registration: 3007118403 (Harckesheyde 95) |
|---|---|
| Contact Person: | Waldemar Link GmbH & Co. KGDr. Karen Sonnenberger (Regulatory Affairs)Oststraße 4-1022844 Norderstedt, GermanyPhone: +49-40 53995-530Fax: +49-40 53995-174E-Mail: k.sonnenberger@linkhh.de |
| Date Prepared: | May 22, 2019 |
| Trade Name: | MobileLink® Acetabular Cup System |
| Common Name: | Acetabular Shells |
| Classification Name: | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.; 21 CFR §888.3353, product code LZOHip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.; 21 CFR §888.3353, product code MEHHip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. 21 CFR §888.3358, product code OQGHip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. 21 CFR §888.3358, product code LPH |
| Classification and Panel: | Class II, Orthopedic / 87 |
| Predicate Devices: | G7 Acetabular System, K121874, K140669, K142882 (Biomet)Trinity Acetabular System, K093472, K110087, K123705, K111481 (Corin) |
| Reference Devices: | EXp highly crosslinked Vitamin E UHMWPE acetabular shell liners, K094035 (Stelkast)Delta TT Actabular Cups, K112898 (Lima Corp.)PlasmaCup with Vitalene Poly, K122873 (Aesculap)HGPII, K840643, K901364 (Zimmer)Omnifit, K912654, K911728 (Osteonics Corp.)PCA, K920831 (Howmedica)Opti-Fix, K864857 (Richards Medical)Tri-Loc, 942966, K943302,K862702 (DePuy)Integrity, K935206, K940486 (Kirschner Medical Corp.)Logical Cup System Acetabular Bone Screws, K121297 (Signature Orthopaedics)LINK® BiMobile™ Dual Mobility System. K171273 (LINK Gmbh & Co KG) |
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Pipeline Total Hip System, K112802 (Pipeline Orthopaedics) Reason for New Device 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. The cup system consists of press-fit metal shells made of a Ti6Al4V alloy. The system offers two designs, a cluster hole shell, with closing screws and a polar screw, and a multi hole shell. Both shells are available with two different coatings, either plasma sprayed coating (PlasmaLink®) or a double coating consisting of plasma spray plus calcium phosphate coating (TiCaP®). All shells are implanted cementless. The acetabular inserts are manufactured from conventional UHMWPE or Vitamin E highly crosslinked UHMWPE (E-Dur®). The inserts are available in six designs, neutral, offset, shouldered, offset/shouldered, 10° and 20° inclination. This premarket notification does not include the femoral components. The MobileLink® Acetabular Cup System is compatible with previously cleared femoral heads (K161840, K953653) and hip stems and neck segments (K161840, K151008, K142187, K953653) of Waldemar Link GmbH & Co. KG. Intended Use: General Indications: The MobileLink® Acetabular Cup System is indicated for patients with mobilitylimiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. Indications: 1) Primary and secondary osteoarthritis 2) Rheumatoid arthritis 3) Correction of functional deformities 4) Avascular necrosis 5) Femoral neck fractures 6) Revision after implant loosening dependent on bone mass and quality The subject device is substantially equivalent to the G7 Acetabular System from Comparison to Predicate Biomet (K121874, K140669, K142882) in terms of intended use, design, range of sizes and materials used. The subject device is substantially equivalent to the Device: Trinity™ System (K093472, K110087, K123705) in terms of intended use, design, range of sizes and materials including coating. Features comparable to the predicate devices include the same indication, dimensions, materials, shelf life, surgical implantation technique and intended use. Performance Non-clinical performance testing and analysis were provided, including bench Testing: testing, UHMWPE and coating characterization, endotoxin testing, and biocompatibility testing (for the E-Dur® UHMWPE). Bench testing included: Disassembly testing (Axial push-out, offset pullout, and torsional tests according to ASTM F1820) for the liner/shell assembly. Wear test according to ISO 14242-1 and particle analysis per ISO 17853 and ASTM F1877 - wear rates compared to Stelkast Exp highly crosslinked Vitamin E UHMWPE acetabular shell liners Wear testing under adverse conditions and particle analysis -Range of Motion according to ISO 21535 -
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- Endotoxin testing -
- -Impingement testing per ASTM F2582
Coating characterization: The coatings were evaluated per "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarked Surveillance Requirements" and "510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implants" Testing included microstructural analysis, mechanical testing and metallurgical analysis.
PE characterization included: The PE materials were characterized according to FDA Guidance, "Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices," and included material characterization, HXL characterization and aging study, and biocompatibility testing and evaluation per ISO 10993.
The results of non-clinical performance testing demonstrate that the device is as safe and effective as the predicate device, and therefore Substantially Equivalent.
- Clinical performance testing was not required to demonstrate the substantial Clinical Testing: equivalence of this device.
- The subject device MobileLink® Acetabular Cup System are substantially Conclusion: equivalent to the predicate devices identified in this premarket notification.
§ 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.