(187 days)
Not Found
No
The summary describes a mechanical component (distal centralizer/centering sleeve) and a manufacturing process change. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The device is an accessory (distal centralizer for a femoral stem) used in hip arthroplasty, which is a surgical procedure to correct anatomical defects rather than directly treating or preventing disease.
No
The device description indicates it is a "cylindrical component[] designed to slide onto the distal end of a cemented femoral stem prior to insertion," which is an surgical implant. The intended use lists conditions it is used to treat, not diagnose.
No
The device description clearly states the device is a "cylindrical component designed to slide onto the distal end of a cemented femoral stem," indicating it is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to surgical procedures for treating joint diseases and fractures. These are therapeutic interventions performed directly on the patient's body.
- Device Description: The device is a component designed to be implanted during hip replacement surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) as part of a surgical implant.
N/A
Intended Use / Indications for Use
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Correction of functional deformity
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
- Revision of previously failed total hip arthroplasty
Product codes
JDG, LZO
Device Description
The subject devices, Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeves, are cylindrical components designed to slide onto the distal end of a cemented femoral stem prior to insertion into the femoral canal.
This submission proposes a new bioburden reduction manufacturing process that includes a new contact material for the Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Proximal femur, femoral canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 Tests:
- A biocompatibility assessment was performed in accordance 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/0 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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
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
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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
-
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
-
- Correction of functional deformity
-
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
-
Revision of previously failed total hip arthroplasty
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Sponsor: | Biomet Inc.
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Establishment Registration Number: 1825034 |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gregory Foster
Sr. Regulatory Specialist
Telephone: (574) 371-0519
Fax: (574) 377-3718
Gregory.foster@zimmerbiomet.com |
| Date: | 07-Feb-2022 |
| Subject Device: | Trade Name: Biomet Answer/Impact/Integral Distal
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
uncemented prosthesis.
• JDG- Prosthesis, Hip, Femoral Component, Cemented, Metal
• LZO - Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer,
Cemented Or Non-Porous, Uncemented |
| Predicate Device(s): | K193546 Distal Centralizers
Biomet, Inc. |
| Device Description: | The subject devices, Biomet Answer/Impact/Integral Distal
Centralizer/Centering Sleeves, are cylindrical components designed to
slide onto the distal end of a cemented femoral stem prior to insertion into
the femoral canal.
This submission proposes a new bioburden reduction manufacturing
process that includes a new contact material for the Biomet
Answer/Impact/Integral Distal Centralizer/Centering Sleeve. |
| Indications for 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 |
| Summary of Technological
Characteristics: | The rationale for substantial equivalence is based on consideration of the
following characteristics:
• Intended Use: Identical to the predicate
• Indications for Use: Identical to the predicate
• Materials: Identical to the predicate
• Design Features: Identical to the predicate
• 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.