(275 days)
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No
The document describes a mechanical implant (acetabular shells) and its components. There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The performance studies are focused on mechanical and material properties.
Yes.
The device is an acetabular shell system intended for use in hip joint replacement surgery for various conditions such as osteoarthritis, rheumatoid arthritis, and fractures. These are medical conditions that require treatment to improve health and function.
No
This device is a medical implant (Acetabular Shells for hip replacements) used for treatment, not for diagnosing conditions.
No
The device description explicitly states it is an additively manufactured acetabular shell made from Ti6Al4V alloy, which is a physical hardware component intended for surgical implantation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for surgical implantation to treat mobility-limiting diseases, fractures, and deformities of the hip joint. This is a therapeutic and structural purpose, not a diagnostic one.
- Device Description: The device is described as an acetabular shell, a component of a hip replacement system. It's made of metal and designed for biological fixation to bone. This is a physical implant, not a reagent, instrument, or system used to examine specimens from the human body.
- No mention of biological specimens: The text does not mention the device being used to test or analyze blood, urine, tissue, or any other biological specimen.
- Performance Studies: The performance studies described are related to the mechanical properties and biocompatibility of the implant, not the accuracy or reliability of diagnostic measurements.
In summary, the device is a surgical implant for hip replacement, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
General indications: 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 Dual Mobility Insert is additionally indicated for: 7) Dislocation risks The MobileLink Acetabular Shells are intended for cementless fixation.
Product codes (comma separated list FDA assigned to the subject device)
LPH, OQG
Device Description
This 510k adds MobileLink TrabecuLink Acetabular Shells to the MobileLink Acetabular Cup System previously cleared in K182321, K192559, K200607. These shells are additively manufactured from Ti6Al4V alloy per ISO 5832-3 and feature a porous structure (TrabecuLink) on the bone interfacing surface for biologic fixation. The shells come in cluster-hole and in multi-hole patterns. mate with the same UHMWPE liners (in conventional PE and highly-crosslinked vitamin E PE) as previously cleared in K182321, and with the same Dual Mobility Inserts and Shell/Insert Adapters previously cleared in K200607. They can be used with the same bone screws cleared in K192559.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Hip Joint
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing and analysis were provided, including: -Acetabular deformation testing -Acetabular fatigue testing -Assessment of disassembly (Push-out, lever-out, torque out for all acetabular modular connections in MobileLink system) Assessment of range of motion --Characterization of the TrabecuLink porous surface -Biocompatibility evaluation -Particle analysis 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.
K182321, K192559, K200607, K140669
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.
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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).
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§ 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.
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April 14, 2023
Waldemar Link GmbH & Co KG % Terry Powell Regulatory Affairs LinkBio Corp. 59 King Street Dover, New Jersey 07801
Re: K222066
Trade/Device Name: LINK MobileLink Acetabular Cup System 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: LPH, OQG Dated: March 20, 2023 Received: March 21, 2023
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/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.
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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.
Limin Sun -S
Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222066
Device Name
LINK MobileLink Acetabular Cup System
Indications for Use (Describe)
General indications:
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: 7) Dislocation risks
The MobileLink 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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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 |
| Alternate
Contact: | Link Bio Corp.
Terry Sheridan Powell (Regulatory Affairs)
69 King Street
Dover, NJ 07801
e-mail: t.powell@linkbio.com |
| Date Prepared: | April 14, 2023 |
| Trade Name: | LINK MobileLink Acetabular Cup System |
| 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 LPH, OQG |
| Classification
and Panel: | Class II, Orthopedic / 87 |
Predicate
Devices:
| Subect Device
Components | Predicate Devices | | 510(k)
Number |
|-----------------------------|-------------------|------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| TrabecuLink
Shells | 1. | MobileLink Acetabular Cup System
Pro Codes: LPH, LZO, MEH, OQG
Waldemar Link GmbH & Co KG
[Primary Predicate] | K182321,
K192559,
K200607 |
| | 2. | G7 OsseoTi Acetabular Shell
Pro Codes: LPH, JDI, KWZ, LZO, OQG, OQH, OQI, PBI
Biomet, Inc. (Zimmer Biomet) | K140669 |
Reason for Submission
New Device System Components – TrabecuLink Shells
Device This 510k adds MobileLink TrabecuLink Acetabular Shells to the MobileLink Description: Acetabular Cup System previously cleared in K182321, K192559, K200607.
These shells are additively manufactured from Ti6Al4V alloy per ISO 5832-3 and feature a porous structure (TrabecuLink) on the bone interfacing surface for biologic fixation. The shells come in cluster-hole and in multi-hole patterns.
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mate with the same UHMWPE liners (in conventional PE and highly-crosslinked vitamin E PE) as previously cleared in K182321, and with the same Dual Mobility Inserts and Shell/Insert Adapters previously cleared in K200607. They can be used with the same bone screws cleared in K192559. 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 Rheumatoid arthritis 2) 3) Correction of functional deformities 4) Avascular necrosis Femoral neck fractures 5) 6) Revision after implant loosening dependent on bone mass and quality The MobileLink Dual Mobility Insert is additionally indicated for: 7) Dislocation risks The MobileLink Acetabular Shells are intended for cementless fixation. Comparison to The subject MobileLink TrabecuLink Acetabular Shells differ from the predicate Predicate Device: MobileLink Acetabular Shells (K182321) in that the subject shells are additive manufactured and feature a 3-D porous surface (TrabecuLink) that is integrated with the shell substrate during the additive manufacturing process. This feature (additively manufactured shell with integrated porous surface) is equivalent to the predicate Zimmer/Biomet G7 Acetabular Cup System with OsseoTi Shells (K140669). The subject MobileLink TrabecuLink Acetabular Shells are similar to the predicate MobileLink Acetabular Shells (K182321) in that they are made of Ti6Al4V alloy, and come in the same sizes and design variants (cluster hole or multi-hole), have the same interior geometry and mate with all of the same previously cleared MobileLink polyethylene inserts, Dual Mobility CoCr Inserts, Adapters (face changers) and bone screws. Performance Non-clinical performance testing and analysis were provided, including: Testing: -Acetabular deformation testing -Acetabular fatigue testing -Assessment of disassembly (Push-out, lever-out, torque out for all acetabular modular connections in MobileLink system) Assessment of range of motion --Characterization of the TrabecuLink porous surface -Biocompatibility evaluation -Particle analysis The results of non-clinical performance testing demonstrate that the device is as
safe and effective as the predicate device, and therefore Substantially Equivalent.
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- Clinical Testing: Clinical performance testing was not required to demonstrate the substantial equivalence of this device.
- Conclusion: The subject MobileLink TrabecuLink Acetabular Shells are substantially equivalent to the predicate devices identified in this premarket notification.