(270 days)
No
The document describes a mechanical implant system and its materials, with no mention of AI or ML in its design, function, or testing.
Yes
The device is an acetabular cup system designed to treat conditions like osteoarthritis, fractures, and necrosis, which are mobility-limiting diseases, by replacing parts of the hip joint. This aligns with the definition of a therapeutic device as it is intended to treat or alleviate a medical condition.
No
Explanation: This device is an acetabular cup system, which is an orthopedic implant used for joint replacement. Its intended use is to treat mobility-limiting diseases, fractures, or defects, which is a therapeutic purpose, not a diagnostic one.
No
The device description clearly states it is a "versatile cup system" consisting of "press-fit metal shells" and "acetabular inserts," which are physical hardware components.
Based on the provided text, the MobileLink® Acetabular Cup System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use/Indications for Use: The indications describe conditions affecting the hip joint that require surgical intervention. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a surgical implant used in hip replacement surgery. It is a physical component implanted into the body.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or screening
- Reagents, calibrators, or controls
The MobileLink® Acetabular Cup System is clearly a medical device intended for surgical implantation to treat hip joint issues.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
LZO, MEH, OQG, LPH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing and analysis were provided, including bench 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 - 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 equivalence of this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K121874, K140669, K142882, K093472, K110087, K123705, K111481
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K094035, K112898, K122873, K840643, K901364, K912654, K911728, K920831, K864857, 942966, K943302, K862702, K935206, K940486, K121297, K171273, K112802
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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.
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."
3
510(k) Summary
| 510(k) Submitter: | Waldemar Link GmbH & Co. KG
Barkhausenweg 10
22339 Hamburg, Germany
Phone: +49-40-539950
Facility Registration: 3003386935 (Oststraße 4-10)
Facility Registration: 3007118403 (Harckesheyde 95) |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Waldemar Link GmbH & Co. KG
Dr. Karen Sonnenberger (Regulatory Affairs)
Oststraße 4-10
22844 Norderstedt, Germany
Phone: +49-40 53995-530
Fax: +49-40 53995-174
E-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 LZO
Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.; 21 CFR §888.3353, product code MEH
Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. 21 CFR §888.3358, product code OQG
Hip 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) |
4
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 -
5
- 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.