Acetabular Bone Screws (for MobileLink Acetabular Cup System)

K192559 · Waldemar Link GmbH & Co. KG · LZO · Dec 21, 2019 · Orthopedic

Device Facts

• Record ID: K192559
• Device Name: Acetabular Bone Screws (for MobileLink Acetabular Cup System)
• Applicant: Waldemar Link GmbH & Co. KG
• Product Code: LZO · Orthopedic
• Decision Date: Dec 21, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

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: 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

Device Story

Acetabular bone screws; 6.5mm diameter; various lengths; manufactured from Ti6Al4V alloy. Accessory to MobileLink Acetabular Cup System; provides supplemental fixation for acetabular shells during hip arthroplasty. Used by orthopedic surgeons in clinical/OR settings. Screws inserted into acetabular bone to enhance stability of cup implant. Benefits include improved fixation in cases of compromised bone quality or revision surgery.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via non-clinical bench testing, including bone screw testing per ASTM F543, endotoxin testing, and biocompatibility evaluation.

Technological Characteristics

Material: Ti6Al4V alloy per ISO 5832-3 and ASTM F136. Dimensions: 6.5mm diameter, various lengths. Function: Supplemental mechanical fixation for acetabular shells. Sterilization: Not specified.

Indications for Use

Indicated for patients with mobility-limiting diseases, fractures, or defects (e.g., osteoarthritis, rheumatoid arthritis, functional deformities, avascular necrosis, femoral neck fractures, revision cases) requiring hip joint replacement where conservative or osteosynthetic procedures are insufficient.

Regulatory Classification

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.

Predicate Devices

• MobileLink Acetabular Shells (K182321)
• Signature Orthopedics 6.5mm bone screws (K121297)

Submission Summary (Full Text)

{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 ([e-mail]) or phone [phone] 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:

- 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

| 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)<br>Submitter: | Waldemar Link GmbH & Co. KG<br>Barkhausenweg 10<br>22339 Hamburg, Germany<br>Phone: [phone]<br>FEI Number: 3003386935 (Oststraße 4-10) |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Waldemar Link GmbH & Co. KG<br>Dr. Karen Sonnenberger (Regulatory Affairs)<br>Oststraße 4-10<br>22844 Norderstedt, Germany<br>Establishment Registration Number: 3004371426<br>Phone: [phone]<br>Fax: [phone]<br>E-Mail: [e-mail] |
| Date Prepared: | December 19, 2019 |
| Trade Name: | Acetabular Bone Screws (MobileLink® Acetabular Cup System) |
| Common Name: | Bone Screws |
| Classification<br>Name: | Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous<br>uncemented prosthesis .; 21 CFR §888.3353, product code LZO<br>Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous<br>uncemented prosthesis .; 21 CFR §888.3353, product code MEH<br>Hip joint metal/polymer/metal semi-constrained porous-coated uncemented<br>prosthesis. 21 CFR §888.3358, product code OQG<br>Hip joint metal/polymer/metal semi-constrained porous-coated uncemented<br>prosthesis. 21 CFR §888.3358, product code LPH |
| Classification<br>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<br>Submission | Add accessory bone screws to predicate acetabular cup system |
| Device<br>Description: | The subject devices are 6.5mm diameter acetabular bone screws in various lengths<br>manufactured from Ti6Al4V alloy. They are accessories to the predicate<br>MobileLink® Acetabular Cup System (K182321). |
| Intended Use: | General Indications:<br>The MobileLink® Acetabular Cup System is indicated for patients with mobility-<br>limiting diseases, fractures or defects which cannot be treated by conservative or<br>osteosynthetic procedures.<br>Indications:<br>Primary and secondary osteoarthritis<br>1)<br>Rheumatoid arthritis<br>2)<br>Correction of functional deformities<br>3)<br>Avascular necrosis<br>4)<br>Femoral neck fractures<br>5)<br>Revision after implant loosening dependent on bone mass and quality<br>6) |
| Comparison to<br>Predicate<br>Device: | The subject acetabular bone screws are intended for optional use with the parent<br>MobileLink Acetabular Shell bodies (K182321) in cases where the surgeon<br>chooses supplemental bone screw fixation. They do not change the indications for<br>use of the parent device systems. The bone screws are manufactured from the<br>same Ti6Al4V alloy per ISO 5832-3 and ASTM F136 used for manufacture of the<br>parent MobileLink Acetabular Shell bodies (K182321). |
| | The subject and predicate bone screws (K121297) provide supplemental screw<br>fixation for acetabular shells, are manufactured from Ti6Al4V alloy, are available<br>in Ø 6.5mm and various lengths. Minor differences in technological features do<br>not raise new questions of safety or effectiveness. Bench testing demonstrated<br>equivalent performance. |
| Performance<br>Testing: | Non-clinical testing and analysis included:<br>- Bone screw testing according to ASTM F543<br>- Endotoxin testing<br>- Biocompatibility evaluation<br><br>The results of non-clinical performance testing demonstrate that the device is as<br>safe and effective as the predicate device, and therefore Substantially Equivalent. |
| Clinical Testing: | Clinical performance testing was not required to demonstrate the substantial<br>equivalence of this device. |
| Conclusion: | The subject bone screws for the MobileLink® Acetabular Cup System are<br>substantially equivalent to the predicate devices identified in this premarket<br>notification. |

{4}------------------------------------------------