(95 days)
No
The 510(k) summary describes bone screws and an acetabular cup system, which are mechanical implants. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are focused on mechanical and biocompatibility testing.
Yes
The device is indicated for treating mobility-limiting diseases, fractures, or defects, which is a therapeutic purpose.
No
The device, the MobileLink® Acetabular Cup System, primarily serves a therapeutic purpose by replacing or repairing diseased or damaged acetabular components in patients. Its indications describe conditions that require surgical intervention rather than diagnostic evaluation.
No
The device description explicitly states the device is a physical bone screw made from Ti6Al4V alloy, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states the device is a "6.5mm diameter acetabular bone screw" and an "accessory to the predicate MobileLink® Acetabular Cup System." These are physical implants used in surgical procedures.
- Intended Use: The intended use describes the conditions the device is used to treat (osteoarthritis, fractures, etc.) and the surgical context (acetabular cup system). This is a therapeutic use, not a diagnostic one.
- Lack of Diagnostic Information: There is no mention of the device being used to analyze samples or provide diagnostic information about a patient's condition.
This device is a surgical implant used to treat musculoskeletal conditions, not a diagnostic tool.
N/A
Intended Use / Indications for Use
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
LZO. MEH. OOG. LPH
Device Description
The subject devices are 6.5mm diameter acetabular bone screws in various lengths manufactured from Ti6Al4V alloy. They are accessories to the predicate MobileLink® Acetabular Cup System (K182321).
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 testing and analysis included:
- Bone screw testing according to ASTM F543
- Endotoxin testing
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Waldemar Link GmbH & Co KG, MobileLink Acetabular Shells (K182321), Signature Orthopedics 6.5mm bone screws (K121297)
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
December 21, 2019
Image /page/0/Picture/1 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 and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is in blue text.
Waldemar Link GmbH & Co. KG % Terry Powell Regulatory Affairs Program Director LinkBio Corp. 69 King Street Dover, New Jersey 07801
Re: K192559
Trade/Device Name: Acetabular Bone Screws (for 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. OOG. LPH Dated: September 17, 2019 Received: September 17, 2019
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.
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
1
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 medical devices and radiation-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,
Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma 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) K192559
Device Name
MobileLink® Acetabular Cup System with Acetabular Bone Screws
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 quality
| 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
FEI Number: 3003386935 (Oststraße 4-10) |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Waldemar Link GmbH & Co. KG
Dr. Karen Sonnenberger (Regulatory Affairs)
Oststraße 4-10
22844 Norderstedt, Germany
Establishment Registration Number: 3004371426
Phone: +49-40 53995-517
Fax: +49-40 53995-174
E-Mail: k.sonnenberger@linkhh.de |
| Date Prepared: | December 19, 2019 |
| Trade Name: | Acetabular Bone Screws (MobileLink® Acetabular Cup System) |
| Common Name: | Bone Screws |
| 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 | Waldemar Link GmbH & Co KG, MobileLink Acetabular Shells (K182321) |
| Devices: | Signature Orthopedics 6.5mm bone screws (K121297) [Primary] |
| Reason for
Submission | Add accessory bone screws to predicate acetabular cup system |
| Device
Description: | The subject devices are 6.5mm diameter acetabular bone screws in various lengths
manufactured from Ti6Al4V alloy. They are accessories to the predicate
MobileLink® Acetabular Cup System (K182321). |
| 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
1)
Rheumatoid arthritis
2)
Correction of functional deformities
3)
Avascular necrosis
4)
Femoral neck fractures
5)
Revision after implant loosening dependent on bone mass and quality
6) |
| Comparison to
Predicate
Device: | The subject acetabular bone screws are intended for optional use with the parent
MobileLink Acetabular Shell bodies (K182321) in cases where the surgeon
chooses supplemental bone screw fixation. They do not change the indications for
use of the parent device systems. The bone screws are manufactured from the
same Ti6Al4V alloy per ISO 5832-3 and ASTM F136 used for manufacture of the
parent MobileLink Acetabular Shell bodies (K182321). |
| | The subject and predicate bone screws (K121297) provide supplemental screw
fixation for acetabular shells, are manufactured from Ti6Al4V alloy, are available
in Ø 6.5mm and various lengths. Minor differences in technological features do
not raise new questions of safety or effectiveness. Bench testing demonstrated
equivalent performance. |
| Performance
Testing: | Non-clinical testing and analysis included:
- Bone screw testing according to ASTM F543
- Endotoxin testing
- 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 bone screws for the MobileLink® Acetabular Cup System are
substantially equivalent to the predicate devices identified in this premarket
notification. |
4