Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve

K212431 · Biomet, Inc. · JDG · Feb 7, 2022 · Orthopedic

Device Facts

• Record ID: K212431
• Device Name: Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve
• Applicant: Biomet, Inc.
• Product Code: JDG · Orthopedic
• Decision Date: Feb 7, 2022
• 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

Cylindrical components (distal centralizers/centering sleeves) designed to slide onto distal end of cemented femoral stems; used prior to insertion into femoral canal during hip arthroplasty. Device centers femoral stem within canal; ensures uniform cement mantle. Used in clinical/surgical settings by orthopedic surgeons. Submission introduces new bioburden reduction manufacturing process and new contact material. Benefits include improved implant stability and alignment within femoral canal.

Clinical Evidence

No clinical data provided. Biocompatibility assessment performed per ISO 10993-1 to validate the candidate manufacturing process flow.

Technological Characteristics

Cylindrical centering sleeve; metallic cemented femoral prosthesis component. Materials and design identical to predicate. Biocompatibility validated per ISO 10993-1. Sterilization method identical to predicate.

Indications for Use

Indicated for patients with noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, or proximal femur fractures (non-union, femoral neck, trochanteric) requiring hip arthroplasty, including 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

• K193546 Distal Centralizers

Submission Summary (Full Text)

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February 7, 2022

Biomet, Inc. Gregory Foster Sr. Specialist Regulatory Specialist 56 East Bell Drive PO Box 587 Warsaw, Indiana 4658

Re: K212431

Trade/Device Name: Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve Regulation Number: 21 CFR 888.3360 Regulation Name: Hip Joint Femoral (Hemi-Hip) Metallic Cemented Or Uncemented Prosthesis Regulatory Class: Class II Product Code: JDG, LZO Dated: November 11, 2021 Received: November 12, 2021

Dear Gregory Foster:

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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Limin Sun, Ph.D. 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

### 510(k) Number (if known) K212431

### Device Name

Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve

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> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|------------------------------------------------------------------------------------------------------|
| <div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(k) Summary

| Sponsor: | Biomet Inc.<br>56 East Bell Drive<br>PO Box 587<br>Warsaw, IN 46581<br>Establishment Registration Number: 1825034 |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gregory Foster<br>Sr. Regulatory Specialist<br>Telephone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Date: | 07-Feb-2022 |
| Subject Device: | Trade Name: Biomet Answer/Impact/Integral Distal<br>Centralizer/Centering Sleeve. |
| | Common Name: Prosthesis, Hip, Femoral Component, Cemented, Metal |
| Classification Name: | 21 CFR 888.3360 Hip joint femoral (hemi-hip) metallic cemented or<br>uncemented prosthesis.<br>• JDG- Prosthesis, Hip, Femoral Component, Cemented, Metal<br>• LZO - Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer,<br>Cemented Or Non-Porous, Uncemented |
| Predicate Device(s): | K193546 Distal Centralizers<br>Biomet, Inc. |
| Device Description: | The subject devices, Biomet Answer/Impact/Integral Distal<br>Centralizer/Centering Sleeves, are cylindrical components designed to<br>slide onto the distal end of a cemented femoral stem prior to insertion into<br>the femoral canal.<br><br>This submission proposes a new bioburden reduction manufacturing<br>process that includes a new contact material for the Biomet<br>Answer/Impact/Integral Distal Centralizer/Centering Sleeve. |
| Indications for Use: | 1. Noninflammatory degenerative joint disease including osteoarthritis<br>and avascular necrosis<br>2. Rheumatoid arthritis<br>3. Correction of functional deformity<br>4. Treatment of non-union, femoral neck fracture, and trochanteric<br>fractures of the proximal femur with head involvement, unmanageable<br>using other techniques<br>5. Revision of previously failed total hip arthroplasty |
| Summary of Technological<br>Characteristics: | The rationale for substantial equivalence is based on consideration of the<br>following characteristics:<br>• Intended Use: Identical to the predicate<br>• Indications for Use: Identical to the predicate<br>• Materials: Identical to the predicate<br>• Design Features: Identical to the predicate<br>• Sterilization: Identical to the predicate |

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

#### Non-Clinical Tests: ●

- A biocompatibility assessment was performed in accordance O with ISO 10993-1. The data provided by the testing confirmed the biocompatibility of the candidate manufacturing process flow for the Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve in long-term contact with patient bone and tissues.
#### Clinical Tests: ●

- o None provided
## Substantial Equivalence Conclusion

Based on the information contained within this submission, it is concluded that the Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve are substantially equivalent to the identified predicate device.