Distal Centralizers

K193546 · Biomet, Inc. · JDG · Sep 25, 2020 · Orthopedic

Device Facts

• Record ID: K193546
• Device Name: Distal Centralizers
• Applicant: Biomet, Inc.
• Product Code: JDG · Orthopedic
• Decision Date: Sep 25, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty.

Device Story

Distal Centralizers are cylindrical components; designed to slide onto distal end of cemented femoral stem prior to insertion into femoral canal. Used during hip arthroplasty procedures; operated by orthopedic surgeons. Device ensures proper positioning of femoral stem within femoral canal during cementation. Benefits patient by facilitating stable fixation of femoral prosthesis. Subject device represents modification to bioburden reduction process (transition to REVOX technology).

Clinical Evidence

No clinical data provided. Bench testing only: geometric evaluation and validation of REVOX bioburden reduction process regarding sterilization, shelf life, and biocompatibility.

Technological Characteristics

Cylindrical components; material identical to predicate. Sterilization process uses REVOX technology. No software or energy source.

Indications for Use

Indicated for patients with noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, non-union, femoral neck/trochanteric fractures of the proximal femur, or those requiring revision of failed total hip arthroplasty.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.

Predicate Devices

• Integral Co-Cr Femoral Components; Including PMMA Distal Centralizers (K942479)

Submission Summary (Full Text)

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September 25, 2020

Biomet Inc. Rhonda Myer Project Manager & Regulatory Affairs Zimmer Biomet 1800 West Center Street Warsaw, Indiana 46580

Re: K193546

Trade/Device Name: Distal Centralizers Regulation Number: 888.3360 Regulation Name: Hip Joint Femoral (Hemi-Hip) Metallic Cemented Or Uncemented Prosthesis Regulatory Class: Class II Product Code: JDG Dated: August 24, 2020 Received: August 26, 2020

Dear Rhonda Myer:

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 [phone] or 301-796-7100).

Sincerely,

FOR Vesa Vuniqi Acting 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)

K193546

Device Name Distal Centralizers

Indications for Use (Describe)

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.

2. Rheumatoid arthritis

3. Correction of functional deformity

4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

5. Revision of previously failed total hip arthroplasty.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| <div> <span style="font-size: 100%;"> <span style="text-decoration: underline;"></span> <span style="text-decoration: overline;"></span> <span style="text-decoration: line-through;"></span> <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;">☑</span> </span> </span> </div> Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Distal Centralizer 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on September 13, 2019.

| Sponsor: | Biomet Inc.<br>56 East Bell Drive<br>PO Box 587<br>Warsaw, IN 46581<br>Establishment Registration Number: 1825034 |
|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person: | Rhonda Myer<br>Regulatory Affairs Senior Project Manager<br>Telephone: [phone] |
| Secondary Contact Person: | Jason Heckaman<br>Regulatory Affairs Associate Director<br>Telephone: [phone] |
| Date: | September 25, 2020 |
| Subject Device: | Trade Name: Distal Centralizers<br>Common Name: Prosthesis, Hip, Femoral Component,<br>Cemented, Metal<br>Classification Name: JDG ">– prosthesis, hip, femoral<br>component, cemented, metal (21 CFR 888.3360) |
| Predicate Device(s): | |
| Device | 510(k) Number |
| Integral Co-Cr Femoral Components; Including PMMA Distal Centralizers | K942479 |

| Purpose and Device<br>Description: | The purpose of this submission is to move the subject devices from Branson bioburden reduction process into a bioburden reduction process using REVOX technology. Additionally, this submission is intended to ensure modifications made since the last clearance have been reviewed by the FDA.<br><br>The subject devices, Distal Centralizers, are cylindrical components designed to slide onto the distal end of a cemented femoral stem prior to insertion into the femoral canal. |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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Indications for Use:

### Summary of Technological Characteristics:

### Summary of Performance Data: (Nonclinical and/or Clinical)

Substantial Equivalence Conclusion:

- 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- 2. Rheumatoid arthritis
- 3. Correction of functional deformity
- Treatment of non-union, femoral neck fracture, and 4. trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
- 5. Revision of previously failed total hip arthroplasty

The rationale for substantial equivalence is based on consideration of the following characteristics:

- Intended Use: Identical to predicate
- Indications for Use: Identical to predicate ●
- Materials: Identical to predicate ●
- Design Features: Similar to predicate
- o Sterilization: Identical to predicate

#### Non-Clinical Tests:

Testing was completed to demonstrate that the change in bioburden reduction process using REVOX technology does not have any impact on sterilization, shelf life, or biocompatibility of the device. Additionally, the results of the Geometric Evaluation Analyses demonstrate the subject devices met the established acceptance criterion. Collectively, these reports demonstrate the modifications being submitted at this time, since the last clearance, will perform as intended and is substantially equivalent to the predicate device(s) referenced in the submission.

#### Clinical Tests:

None provided

The proposed Distal Centralizers have the identical intended use and indications for use as the predicate devices. The proposed devices have similar technological characteristics to the predicates, and the information provided herein demonstrates that:

- any differences do not raise new questions of safety and effectiveness; and
- the proposed devices are at least as safe and effective as the legally marketed predicate devices.