(445 days)
No
The 510(k) summary describes a mechanical acetabular cup system and its components. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies are focused on mechanical and material properties.
Yes
The device is an acetabular cup system intended to treat mobility-limiting diseases, fractures, or defects, which are therapeutic indications. It replaces or supplements damaged body parts to restore function.
No
The MobileLink® Acetabular Cup System is an implantable device used for hip replacement; it addresses existing medical conditions rather than diagnosing them.
No
The device description clearly states it is a "versatile cup system" and describes physical components like "Dual Mobility Inserts" made of "CoCrMo alloy" and "Shell/Insert Adapters" made of "Ti6Al4V alloy". This indicates 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 surgical implant system for treating mobility-limiting diseases, fractures, and defects of the hip joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical components like acetabular cups, dual mobility inserts, and shell/insert adapters, all designed for surgical implantation.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the mechanical and biocompatibility aspects of the implant, which are relevant to surgical devices, not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
General indications: The MobileLink(0) Acetabular Cup System is indicated for patients with mobility-limiting 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 MobileLink(8) Dual Mobility Insert is additionally indicated for: 7) Dislocation risks The MobileLink(8) Acetabular Shells are intended for cementless fixation.
Product codes (comma separated list FDA assigned to the subject device)
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. This 510k adds several system components to the MobileLink® Acetabular Cup System previously cleared in K182321. Dual Mobility Inserts: The Dual Mobility Inserts are manufactured from CoCrMo alloy. They assemble by taper lock to any MobileLink® Acetabular Shell (either the PlasmaLink or TiCaP versions cleared in K182321) and mate with polyethylene Dual Mobility Liners (from the BiMobile System cleared in K171273 and K190535. Shell/Insert Adapters ("face changers"): These are optional components that can be used as an interface between the MobileLink® Acetabular metal shells (either the PlasmaLink or TiCaP versions cleared in K182321) and the neutral and shouldered polyethylene inserts to adjust the center of rotation and anteversion angles. They are manufactured from Ti6Al4V alloy, and come in various designs: neutral, offset, offset with 10° inclination, and offset with 20° inclination. The neutral version assembles to the mating shell by taper lock only, while the other versions assemble by taper lock plus an assembly screw.
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
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 testing and analysis were provided, including: - Acetabular construct disassembly testing (Push-out, lever-out, torque out for all acetabular modular connections) - Fretting/Corrosion testing - Impingement testing - Range of Motion analysis according to ISO 21535 - Biocompatibility evaluation 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.
K103233, K150522, K190535, K182321
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.
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
§ 888.3358 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 28, 2021
Waldemar Link GmbH & Co. KG % Terry Powell Regulatory Affairs LinkBio Corp. 69 King Street Dover, New Jersey 07801
Re: K200607
Trade/Device Name: MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters 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: OQG, LPH Dated: February 1, 2021 Received: February 1, 2021
Dear Terry Powell:
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/ofdocs/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.
1
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 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,
for
William Jung, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K200607
Device Name
LINK MobileLink(R) Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters
Indications for Use (Describe)
General indications:
The MobileLink(0) 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(8) Dual Mobility Insert is additionally indicated for:
- Dislocation risks
The MobileLink(8) Acetabular Shells are intended for cementless fixation.
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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3
510(k) Summary
| 510(k)
Submitter: | Waldemar Link GmbH & Co. KG
Barkhausenweg 10
22339 Hamburg, Germany
Phone: +49-40-539950
Facility Registration: 3003386935 |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Waldemar Link GmbH & Co. KG
Stefanie Fuchs (Regulatory Affairs)
Oststraße 4-10
22844 Norderstedt, Germany
Phone: +49-40 53995-530
Fax: +49-40 53995-174
E-Mail: st.fuchs@linkhh.de |
| Date Prepared: | May 27, 2021 |
| Trade Name: | LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/
Insert Adapters |
| Common Name: | Total hip replacement system |
| Classification
Name: | Hip joint metal/polymer/metal semi-constrained porous-coated uncemented
prosthesis. 21 CFR §888.3358, product code OQG, LPH |
| Classification
and Panel: | Class II, Orthopedic / 87 |
Predicate
Devices:
| Subect Device
Components | Predicate Devices | 510(k)
Number |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------|------------------|
| Dual Mobility
Inserts | 1. Modular Dual Mobility (MDM) Liner
Pro Codes: LZO, MEH
Stryker Orthopaedics (Howmedica Osteonics)
[Primary Predicate] | K103233 |
| | 2. G7 Dual Mobility System
Pro Codes: LPH, KWY, LZO, OQG
Biomet Inc. (Zimmer Biomet) | K150522 |
| | 3. BiMobile Dual Mobility System
Pro Codes: MEH, LZO
Waldemar Link GmbH & Co KG | K190535 |
| Shell/Insert
Adapters | 1. MobileLink®Acetabular Cup System, Polyethylene
liners in neutral, offset, 10° and 20° inclinations
[Primary Predicate] | K182321 |
| | 2. Modular Dual Mobility (MDM) Liner
Pro Codes: LZO, MEH
Stryker Orthopaedics (Howmedica Osteonics) | K103233 |
Reason for
New Device System Components
Submission
4
- The MobileLink® Acetabular Cup System is a versatile cup system, designed to Device 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.
Dual Mobility Inserts: The Dual Mobility Inserts are manufactured from CoCrMo alloy. They assemble by taper lock to any MobileLink® Acetabular Shell (either the PlasmaLink or TiCaP versions cleared in K182321) and mate with polyethylene Dual Mobility Liners (from the BiMobile System cleared in K171273 and K190535.
Shell/Insert Adapters ("face changers"): These are optional components that can be used as an interface between the MobileLink® Acetabular metal shells (either the PlasmaLink or TiCaP versions cleared in K182321) and the neutral and shouldered polyethylene inserts to adjust the center of rotation and anteversion angles. They are manufactured from Ti6Al4V alloy, and come in various designs: neutral, offset, offset with 10° inclination, and offset with 20° inclination. The neutral version assembles to the mating shell by taper lock only, while the other versions assemble by taper lock plus an assembly screw.
Intended 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
The MobileLink® Dual Mobility Insert is additionally indicated for:
-
- Dislocation risks
The MobileLink® Acetabular Shells are intended for cementless fixation.
- Dislocation risks
Comparison to The subject and predicate Dual Mobility Inserts are each modular CoCr inserts Predicate Device: that fit within titanium alloy acetabular shells by means of a taper connection to allow a dual mobility construct wherein a femoral head articulates within the poly liner, and a poly liner articulates within the Dual Mobility Insert assembled within the acetabular shell.
The subject Shell/Insert Adapters are used within a modular acetabular construct to allow the surgeon to adjust the center of rotation and to adjust the anteversion angles by 10° or 20° (depending on design). This is the same purpose as the predicate MobileLink polyethylene liners (K182321) which also allow the surgeon to adjust the center of rotation and to adjust the anteversion angles by 10° or 20° (depending on design). The Shell/Insert Adaptors introduce another modular junction (between the shell and the polyethylene liner), but this technological difference raises no new questions of safety or effectiveness, and
5
| established non-clinical tests of the modular assembly are sufficient to demonstrate substantial equivalence. | |
|---|---|
| Performance | |
| Testing: | Non-clinical performance testing and analysis were provided, including: |
- Acetabular construct disassembly testing (Push-out, lever-out, torque out for all acetabular modular connections)
- Fretting/Corrosion testing
- Impingement testing
- Range of Motion analysis according to ISO 21535
- Biocompatibility evaluation |
| | 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 Testing: | Clinical performance testing was not required to demonstrate the substantial equivalence of this device. |
| Conclusion: | The subject MobileLink® Acetabular Cup System is substantially equivalent to the predicate devices identified in this premarket notification. |