(263 days)
No
The summary describes a mechanical implant system and its materials. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for treating various mobility-limiting diseases, fractures, or defects, which are conditions that impact a patient's health and well-being. It is intended to provide a medical benefit by replacing or assisting a body part.
No
This device is a surgical implant (dual mobility acetabular implant system) used for treating various hip conditions, not for diagnosing them. Its intended use is to replace or revise components within the hip joint.
No
The device description clearly details a physical implant system made of metal and polyethylene components, intended for surgical implantation. It does not describe any software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a surgical implant for treating mobility-limiting diseases, fractures, and defects of the hip. This involves direct intervention within the body.
- Device Description: The description details a physical implant system made of metal and polyethylene components designed to replace or augment the acetabulum (hip socket).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically tests or instruments used in a laboratory or clinical setting to analyze biological samples.
Therefore, the LINK® BiMobile™ Dual Mobility System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LINK® BiMobile™ Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures.
The LINK® BiMobile™ Dual Mobility System is indicated for the following conditions:
- Primary and secondary coxarthrosis
- Osteoarthritis
- Necrosis of the femoral head
- Femoral neck fractures
- Revision after implant loosening
- Acetabular dysplasia
The device is intended for cemented and cementless use.
Product codes (comma separated list FDA assigned to the subject device)
MEH, LZO
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).
This premarket notification does not include the femoral components. The LINK® BiMobile™ Dual Mobility System is compatible with the FDA cleared LINK® femoral stems of the SP-CL® / LCU® (K161840); and the Lubinus SPII® (K953653) hip systems, with the MP® Reconstruction Prosthesis (K142187) and MEGASYSTEM-C® (K151008) neck segments and with the femoral heads made of cobaltchromium and ceramic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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:
Non-clinical performance testing and analysis were provided including bench testing, coating characterization and endotoxin testing. Bench testing included: Wear test per ISO 14242-1 and -2; Particles Analyses per ISO 17853 and ASTM F1877; Liner Press-in testing; Lever-out testing, Axial Disassembly testing and Range of Motion analyses of the LINK® BiMobile™ Dual Mobility System.
The coating was evaluated per FDA Guidance Documents entitled "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". Coating characterization included: Microstructural analysis; Mechanical testing and Metallurgical 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 Performance and Conclusions:
There was no clinical performance testing required for 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.
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.
K161840, K953653, K142187, K151008
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 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 Henrik Kroh Regulatory Affairs Barkhausenweg 10 22339 Hamburg, Germany
January 19, 2018
Re: K171273
Trade/Device Name: LINK® BiMobile™ Dual Mobility 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: MEH, LZO Dated: December 20, 2017 Received: December 22, 2017
Dear Mr. Kroh:
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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K171273
Device Name LINK® BiMobile™ Dual Mobility System
Indications for Use (Describe)
The LINK® BiMobile™ Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures.
The LINK® BiMobile™ Dual Mobility System is indicated for the following conditions:
- · Primary and secondary coxarthrosis
- · Osteoarthritis
- Necrosis of the femoral head
- Femoral neck fractures
- · Revision after implant loosening
- · Acetabular dysplasia
The device is intended for cemented and cementless use.
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)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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
Henrik Kroh (Regulatory Affairs)
Oststraße 4-10
Norderstedt, GERMANY 22844
Phone: +49-40 53995-573
Fax: +49-40 53995-174
E-Mail: H.Kroh@linkhh.de | | | |
| Date Prepared: | January 19th, 2018 | | | |
| Trade Name: | LINK® BiMobile™ Dual Mobility System | | | |
| 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: | Restoration™ ADM System by Howmedica, K072020,
cleared October 18, 2007 | | | |
| | Trinity Acetabular System by Corin, K093472, cleared
November 23, 2010 | | | |
| | NOVAE® Dual Mobility Acetabular Cup by SERF, K111572,
cleared August 29, 2011 | | | |
| 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 | | | |
4
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).
This premarket notification does not include the femoral components. The LINK® BiMobile™ Dual Mobility System is compatible with the FDA cleared LINK® femoral stems of the SP-CL® / LCU® (K161840); and the Lubinus SPII® (K953653) hip systems, with the MP® Reconstruction Prosthesis (K142187) and MEGASYSTEM-C® (K151008) neck segments and with the femoral heads made of cobaltchromium and ceramic.
Indications for Use: The LINK® BiMobile™ Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures.
The LINK® BiMobile™ Dual Mobility System is indicated for the following conditions:
-
- Primary and secondary coxarthrosis
-
- Osteoarthritis
-
- Necrosis of the femoral head
-
- Femoral neck fractures
-
- Revision after implant loosening
-
- Acetabular dysplasia
The device is intended for cemented and cementless use.
The LINK® BiMobile™ Comparison to Predicate Device: Dual Mobility System is substantially equivalent to ADM® Mobile Bearing Hip System (K072020).
Features comparable to the predicate devices include the indications, dimensions, materials, packaging, same sterilization, surgical implantation technique and intended use.
| Performance Data: | Non-Clinical Performance and Conclusions: | |||||
|---|---|---|---|---|---|---|
| Non-clinical performance testing and analysis were provided | ||||||
| including bench testing, coating characterization and |
5
endotoxin testing. Bench testing included: Wear test per ISO 14242-1 and -2; Particles Analyses per ISO 17853 and ASTM F1877; Liner Press-in testing; Lever-out testing, Axial Disassembly testing and Range of Motion analyses of the LINK® BiMobile™ Dual Mobility System.
The coating was evaluated per FDA Guidance Documents entitled "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".
Coating characterization included: Microstructural analysis; Mechanical testing and Metallurgical 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 Performance and Conclusions:
There was no clinical performance testing required for this device.
The subject device LINK® BiMobile™ Dual Mobility System Conclusion: with a PlasmaLink® or TiCaP® coating is substantially equivalent to the predicate devices identified in this premarket notification.