(155 days)
No
The device description and performance studies focus on the material properties and mechanical performance of the implant, with no mention of AI or ML.
No.
A therapeutic device is one that treats a disease or condition. This device is an implant system designed to address mobility issues, fractures, or defects of the hip joint, and its purpose is related to mechanical replacement or revision rather than actively treating a disease or condition in the therapeutic sense.
No
This device is an acetabular implant system used to treat hip joint or proximal femur conditions, not to diagnose them.
No
The device description clearly outlines physical components made of metal alloys and polyethylene, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body to treat physical conditions of the hip joint and proximal femur. IVDs are used to examine specimens from the body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as an implantable system consisting of metal shells and polyethylene liners. This is consistent with a surgical implant, not a diagnostic test.
- Anatomical Site: The device is used in the hip joint and proximal femur, which are anatomical locations within the body.
- Performance Studies: The performance studies described are non-clinical mechanical and wear testing, which are relevant to the function and durability of an implant, not the accuracy of a diagnostic test.
Therefore, the BiMobile Dual Mobility System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BiMobile Dual Mobility 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. The BiMobile Dual Mobility System is indicated for the following conditions:
- · 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
- · Dislocation risks
The device is intended for cemented and cementless use.
Product codes
LZO, MEH
Device Description
The BiMobile cup system is a dual mobility acetabular implant system. The system is consisting of wrought cobalt chromium molybdenum alloy (CoCrMo acc. to ISO 5832-12) metal shells with a highly polished inner surface, which are available in three different outer surface modifications. There is the cemented version with a glass blasted surface of concentric grooves, and two cementless versions where a pressfit generating macrostructure is covered by either a PlasmaLink (titanium plasma spray acc. to ISO 5832-2/ASTM F1580) or TiCaP (titanium plasma spray and calcium phosphate acc. to ISO 5832-2/ASTM F1580 and F1609) coating. For each size, from 42 to 70, a dedicated liner made of Ultra-high-molecular-weight polyethylene (conventional UHMWPE acc. to ISO 5834-2/ASTM F648) is available. These can be combined with ceramic or CoCr alloy femoral heads of sizes 22 mm (for Size 42-46) and 28 mm (for size 48-70). The purpose of this submission is to add acetabular liners in Vitamin E highly crosslinked UHMWPE (E-Dur) acc. to ASTM F2695, ASTM F2565 to the BiMobile Dual Mobility System. This premarket notification does not include the femoral components. The BiMobile Dual Mobility System is compatible with previously cleared femoral heads (K171273, K161840, K953653, K931571, and K920756), femoral stems and neck segments (K183141, K161840, K151008, K142187, and 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 or proximal femur
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 and Conclusions: The following material characterization, biocompatibility testing/analysis, wear analyses, mechanical testing were performed to demonstrate that the BiMobile E-Dur® Inserts perform as intended and are substantially equivalent to the identified devices:
- Material Characterization
- Biocompatibility Testing and Analysis
- Axial Disassembly Testing
- Lever-out Testing
- Standard and Adverse Wear Anaylses including Particles Analyses
- Range of Motion Analysis
The results of non-clinical performance testing demonstrate that the device is as safe, as effective, and substantially equivalent to the predicate devices.
Clinical Testing: 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)
K171273, K170359, K094035, K182321
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
August 6, 2019
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Waldemar Link GmbH & Co. KG Stefanie Fuchs Regulatory Affairs Manager Oststraße 4-10 Norderstedt, Germany 22844
Re: K190535
Trade/Device Name: BiMobile Dual Mobility System - E-Dur Inserts 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 Dated: July 8, 2019 Received: July 11, 2019
Dear Stefanie Fuchs:
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 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
1
devices or postmarketing safety reporting (21 CFR 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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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-regulatoryassistance/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,
Vesa Vuniqi Acting 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
510(k) Number (if known) K190535
Device Name
BiMobile Dual Mobility System - E-Dur Inserts
Indications for Use (Describe)
The BiMobile Dual Mobility 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. The BiMobile Dual Mobility System is indicated for the following conditions:
- · 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
- · Dislocation risks
The device is intended for cemented and cementless use.
| 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)
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510(k) Summary
| 510(k) Submitter: | Waldemar Link GmbH & Co. KG
Barkhausenweg 10
22339 Hamburg, Germany
Phone: +49-40-539950
Facility Registration #:3004371426 (Oststraße 4-10)
Facility Registration #:3007118403 (Harckesheyde 95) |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Waldemar Link GmbH & Co. KG
Stefanie Fuchs (Regulatory Affairs)
Oststraße 4-10
Norderstedt, GERMANY 22844
Phone: +49-40 53995-530
Fax: +49-40 53995-174
E-Mail: st.fuchs@linkhh.de |
| Date Prepared: | July 07, 2019 |
| Trade Name: | BiMobile Dual Mobility System – E-Dur Inserts |
| Common Name: | Acetabular Cup |
| Classification Name: | Prosthesis, hip, semi-constrained, metal/ceramic/polymer,
cemented or non-porous; 21 CFR §888.3353, product code
LZO
Prosthesis, hip, semi-constrained, uncemented,
metal/polymer, non-porous, calcium-phosphate; 21 CFR
§888.3353, product code MEH |
| Classification and Panel: | Class II, Orthopedic / 87 |
| Predicate Devices: | LINK BiMobile Dual Mobility System, K171273,
cleared January 19, 2018 |
| | Trinity Dual Mobility System with ECiMa Liners by Corin,
K170359, cleared October 31, 2017 |
| | EXp Acetabular Shell Liner by Stelkast, Inc., K094035,
cleared March 24, 2011 |
| | MobileLink Acetabular Cup System, K182321, cleared May
24, 2019 |
| Device Description: | The BiMobile cup system is a dual mobility acetabular
implant system. The system is consisting of wrought cobalt
chromium molybdenum alloy (CoCrMo acc. to ISO 5832-12) |
4
metal shells with a highly polished inner surface, which are available in three different outer surface modifications. There is the cemented version with a glass blasted surface of concentric grooves, and two cementless versions where a pressfit generating macrostructure is covered by either a PlasmaLink (titanium plasma spray acc. to ISO 5832-2/ASTM F1580) or TiCaP (titanium plasma spray and calcium phosphate acc. to ISO 5832-2/ASTM F1580 and F1609) coating. For each size, from 42 to 70, a dedicated liner made of Ultra-high-molecular-weight polyethylene (conventional UHMWPE acc. to ISO 5834-2/ASTM F648) is available. These can be combined with ceramic or CoCr alloy femoral heads of sizes 22 mm (for Size 42-46) and 28 mm (for size 48-70). The purpose of this submission is to add acetabular liners in Vitamin E highly crosslinked UHMWPE (E-Dur) acc. to ASTM F2695, ASTM F2565 to the BiMobile Dual Mobility System. This premarket notification does not include the femoral components. The BiMobile Dual Mobility System is compatible with previously cleared femoral heads (K171273, K161840, K953653, K931571, and K920756), femoral stems and neck segments (K183141, K161840, K151008, K142187, and K953653,) of Waldemar Link GmbH & Co. KG. Indications for Use: The BiMobile Dual Mobility 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. The BiMobile Dual Mobility System is indicated for the following conditions: 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 7) Dislocation risks The device is intended for cemented and cementless use. The additional components of the BiMobile Dual Mobility Comparison to Predicate Device:
System are similar to the predicate devices in terms of intended use and indications, materials, sizes, designs and performance.
5
Based on these similarities, the additional components of the BiMobile Dual Mobility System are believed to be substantially equivalent to the predicate device.
| Performance Testing: | Non-Clinical Performance and Conclusions: |
|---|---|
| The following material characterization, biocompatibility | |
| testing/analysis, wear analyses, mechanical testing were | |
| performed to demonstrate that the BiMobile E-Dur® Inserts | |
| perform as intended and are substantially equivalent to the | |
| identified devices: | |
| - Material Characterization |
- Biocompatibility Testing and Analysis
- Axial Disassembly Testing
- Lever-out Testing
- Standard and Adverse Wear Anaylses including Particles
Analyses - Range of Motion Analysis |
| | The results of non-clinical performance testing demonstrate
that the device is as safe, as effective, and substantially
equivalent to the predicate devices. |
| Clinical Testing: | Clinical performance Testing was not required to demonstrate
the substantial equivalence of this device. |
| Conclusion: | The subject device BiMobile E-Dur inserts is substantially
equivalent to the predicate devices identified in this premarket
notification. |