(95 days)
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 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).
This document (K192559) describes the 510(k) premarket notification for "Acetabular Bone Screws (for MobileLink Acetabular Cup System)". It's important to note that this document is for a medical device (bone screws), not an AI or software device. Therefore, the requested information regarding acceptance criteria and studies for an AI/software device does not apply to this submission.
The document discusses the substantial equivalence of the bone screws to predicate devices based on:
- Device Description: 6.5mm diameter acetabular bone screws in various lengths manufactured from Ti6Al4V alloy. They are accessories to the MobileLink® Acetabular Cup System.
- Intended Use: The MobileLink® Acetabular Cup System (with which these screws are used) is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures, including primary and secondary osteoarthritis, rheumatoid arthritis, correction of functional deformities, avascular necrosis, femoral neck fractures, and revision after implant loosening.
- Comparison to Predicate Device: The subject screws provide supplemental screw fixation for acetabular shells, are manufactured from the same Ti6Al4V alloy as the predicate, are available in Ø 6.5mm and various lengths, and minor technological differences do not raise new questions of safety or effectiveness.
- Performance Testing (Non-Clinical):
- Bone screw testing according to ASTM F543.
- Endotoxin testing.
- Biocompatibility evaluation.
- Clinical Testing: "Clinical performance testing was not required to demonstrate the substantial equivalence of this device."
Therefore, I cannot provide the requested information related to AI/software device acceptance criteria and study details because this document does not pertain to such a device.
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December 21, 2019
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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
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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
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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)
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510(k) Summary
| 510(k)Submitter: | Waldemar Link GmbH & Co. KGBarkhausenweg 1022339 Hamburg, GermanyPhone: +49-40-539950FEI Number: 3003386935 (Oststraße 4-10) |
|---|---|
| Contact Person: | Waldemar Link GmbH & Co. KGDr. Karen Sonnenberger (Regulatory Affairs)Oststraße 4-1022844 Norderstedt, GermanyEstablishment Registration Number: 3004371426Phone: +49-40 53995-517Fax: +49-40 53995-174E-Mail: k.sonnenberger@linkhh.de |
| Date Prepared: | December 19, 2019 |
| Trade Name: | Acetabular Bone Screws (MobileLink® Acetabular Cup System) |
| Common Name: | Bone Screws |
| ClassificationName: | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporousuncemented prosthesis .; 21 CFR §888.3353, product code LZOHip joint metal/ceramic/polymer semi-constrained cemented or nonporousuncemented prosthesis .; 21 CFR §888.3353, product code MEHHip joint metal/polymer/metal semi-constrained porous-coated uncementedprosthesis. 21 CFR §888.3358, product code OQGHip joint metal/polymer/metal semi-constrained porous-coated uncementedprosthesis. 21 CFR §888.3358, product code LPH |
| Classificationand 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 forSubmission | Add accessory bone screws to predicate acetabular cup system |
| DeviceDescription: | The subject devices are 6.5mm diameter acetabular bone screws in various lengthsmanufactured from Ti6Al4V alloy. They are accessories to the predicateMobileLink® 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 orosteosynthetic procedures.Indications:Primary and secondary osteoarthritis1)Rheumatoid arthritis2)Correction of functional deformities3)Avascular necrosis4)Femoral neck fractures5)Revision after implant loosening dependent on bone mass and quality6) |
| Comparison toPredicateDevice: | The subject acetabular bone screws are intended for optional use with the parentMobileLink Acetabular Shell bodies (K182321) in cases where the surgeonchooses supplemental bone screw fixation. They do not change the indications foruse of the parent device systems. The bone screws are manufactured from thesame Ti6Al4V alloy per ISO 5832-3 and ASTM F136 used for manufacture of theparent MobileLink Acetabular Shell bodies (K182321). |
| The subject and predicate bone screws (K121297) provide supplemental screwfixation for acetabular shells, are manufactured from Ti6Al4V alloy, are availablein Ø 6.5mm and various lengths. Minor differences in technological features donot raise new questions of safety or effectiveness. Bench testing demonstratedequivalent performance. | |
| PerformanceTesting: | Non-clinical testing and analysis included:- Bone screw testing according to ASTM F543- Endotoxin testing- Biocompatibility evaluationThe results of non-clinical performance testing demonstrate that the device is assafe and effective as the predicate device, and therefore Substantially Equivalent. |
| Clinical Testing: | Clinical performance testing was not required to demonstrate the substantialequivalence of this device. |
| Conclusion: | The subject bone screws for the MobileLink® Acetabular Cup System aresubstantially equivalent to the predicate devices identified in this premarketnotification. |
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§ 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.