(109 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies do not mention any AI/ML capabilities.
Yes.
The device is described as a total knee arthroplasty system intended to correct painful and disabled knee joints, deformities, or failures from previous procedures, which are indications for therapeutic intervention.
No
This device is a knee implant system used in total knee arthroplasty, which is a surgical procedure to replace a damaged knee joint. It is a therapeutic device, not a diagnostic one.
No
The device description and intended use clearly indicate that this submission is for physical knee implants (femoral augments, tibial augments, femoral components, tibial tray components, tibial bearings, patellar components) used in total knee arthroplasty. The performance studies also focus on testing the physical properties of the implants (MR Conditional status, nonpyrogenicity). There is no mention of software as the primary device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for total knee arthroplasty (joint replacement surgery) to address painful and disabled knee joints due to various conditions. This is a surgical procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The device is described as components for total knee arthroplasty.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such testing. The information focuses on the surgical application and the physical properties of the implants.
- Input Imaging Modality: While MRI is mentioned, it's used for pre-operative planning and assessing the condition of the knee, not as a direct input for the device itself to perform a diagnostic test.
- Performance Studies: The performance studies described are related to the physical properties of the implants (MR compatibility, nonpyrogenicity), not the accuracy or performance of a diagnostic test.
In summary, this device is a surgical implant used in a therapeutic procedure, not a diagnostic tool used to analyze samples for medical information.
N/A
Intended Use / Indications for Use
- Painful and disabled knee joint resulting from osteoarthritis, and/or traumatic arthritis where one or more compartments are involved.
- Correction of varus, valgus, or posttraumatic deformity.
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
The Regenerex femoral augments are indicated for use with the Vanguard Total Knee System.
The Regenerex tibial augments are indicated for use with standard and offset Biomet Tibial Trays.
Femoral components and tibial tray components with porous coatings are indicated for cemented biological fixation application. Non-coated (Interlok) devices and all-polyethylene patellar components are indicated for cemented application only.
Regenerex components are intended only for uncemented biologic fixation application.
The tibial bearings are intended for use with Biomet cemented or uncemented tibial trays.
All-polyethylene patellar components are indicated for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH, HRY, MBV, MBH, OIY
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Knee joint
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:
- Biomet has performed non-clinical Magnetic Resonance Imaging (MRI) studies on implants which are determined to be MR Conditional in accordance to ASTM F2503-13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. MR Tests included the following:
- RF heating- ASTM F2182-11a
- Image Distortion- ASTM F2119-07
- Magnetically Induced Displacement Force - ASTM 2052-14
- CEM43 analysis
- Testing has been performed to establish product nonpyrogenicity.
Clinical Tests:
Clinical data was not provided for the subject devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K912245, K915132, K921182, K960856, K993159, K010212, K033489, K040770, K042757, K060525, K080204, K080361, K083782, K102125, K110362, K113550, K121149, K140902, K142933
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, often associated with healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Biomet, Inc Jason Heckaman Manager, Regulatory Affairs 56 East Bell Drive Warsaw, Indiana 46581
saw, Indiana
Re: K171054 Trade/Device Name: Biomet Knee Joint Replacement Prostheses Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, HRY, MBV, MBH, OIY Dated: June 26, 2017 Received: June 27, 2017
July 28, 2017
Dear Mr. Heckaman:
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. 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 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K171054
Device Name
Biomet Knee Joint Replacement Prostheses
Indications for Use (Describe)
-
Painful and disabled knee joint resulting from osteoarthritis, and/or traumatic arthritis where one or more compartments are involved.
-
Correction of varus, valgus, or posttraumatic deformity.
-
Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
The Regenerex femoral augments are indicated for use with the Vanguard Total Knee System.
The Regenerex tibial augments are indicated for use with standard and offset Biomet Tibial Trays.
Femoral components and tibial tray components with porous coatings are indicated for cemented biological fixation application. Non-coated (Interlok) devices and all-polyethylene patellar components are indicated for cemented application only.
Regenerex components are intended only for uncemented biologic fixation application.
The tibial bearings are intended for use with Biomet cemented or uncemented tibial trays.
All-polyethylene patellar components are indicated for cemented use only.
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
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Biomet Knee Joint Replacement Prostheses MR Labeling 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 August 12, 2005.
| Sponsor: | Biomet Inc.
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Establishment Registration Number: 3003506715 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jason Heckaman
Manager, Regulatory Affairs
Telephone: (574-371-8313) |
| Date: | July 27, 2017 |
| Subject Device: | Trade Name: Biomet Knee Joint Replacement
Prostheses MR Labeling
Common Name: Knee Prosthesis |
| | Classification Name:
JWH - Prosthesis, Knee, Patellofemorotibial, Semi-
Constrained, Cemented, Polymer/Metal/Polymer
(21 CFR 888.3560)HRY- Prosthesis, Knee, Femorotibial, Semi-
Constrained, Cemented, Metal/Polymer (21 CFR
888.3530)MBV - Prosthesis, Knee, Patello/Femorotibial,
Semi-Constrained, UHMWPE, Pegged, Cemented,
Polymer/Metal/Polymer (21 CFR 888.3560)MBH - Prosthesis, Knee, Patello/Femorotibial,
Semi-Constrained, Uncemented, Porous, Coated,
Polymer/Metal/Polymer (21 CFR 888.3565)OIY - Prosthesis, Knee, Patellofemorotibial, Semi-
Constrained, Cemented, Polymer +
Additive/Metal/Polymer + Additive (21 CFR
888 3560) |
4
Predicate Device(s):
Manufacturer: Biomet, Inc.
| K912245 | AGC Revision Knee Prosthesis |
|---|---|
| K915132 | MCK (Maximum Congruent Knee) Knee System |
| K921182 | Ultra High Molecular Weight Polyethylene |
| Component | |
| K960856 | Konstruct Patellar Component |
| K993159 | Maxim Knee System |
| K010212 | Offset Tibial Tray |
| K033489 | AGC Total Knee System, Ascent Total Knee System, Maxim Complete Knee System, Maxim |
| Accel Knee System | |
| K040770 | Vanguard Patella Components |
| K042757 | Vanguard SSK Knee System |
| K060525 | Vanguard Removable Molded Poly Tibia |
| K080204 | Vanguard Knee System Titanium Femoral |
| Components | |
| K080361 | Regenerex Tibial Components |
| K083782 | Regenerex Patella Components |
| K102125 | Patient-Specific Vanguard Femoral Components |
| K110362 | Vanguard Asymmetrical Patellar Component |
| K113550 | Vanguard Complete Knee System |
| K121149 | Vanguard SSK 360 Revision Knee System |
| K140902 | E1 Series A Patellae, Standard 3-Peg, E1 Series A Patellae, Thin 3-Peg, E-1 Series A Patellae, |
| Asymmetrical, 3-Peg | |
| K142933 | Biomet Tibial Trays |
Summary of Technological Characteristics:
design features or dimensions, packaging or sterilization. The subject devices are intended for use in total knee arthroplasty.
Indications for Use: 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, and/or traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
5
The Regenerex femoral augments are indicated for use with the Vanguard Total Knee System.
The Regenerex tibial augments are indicated for use with standard and offset Biomet Tibial Trays.
Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (Interlok) devices and all-polyethylene patellar components are indicated for cemented application only.
Regenerex components are intended only for uncemented biologic fixation application.
The tibial bearings are intended for use with Biomet cemented or uncemented tibial trays.
All-polyethylene patellar components are indicated for cemented use only.
Summary of Performance Data (Nonclinical and/or Clinical):
Non-Clinical Tests:
- Biomet has performed non-clinical Magnetic ● Resonance Imaging (MRI) studies on implants which are determined to be MR Conditional in accordance to ASTM F2503-13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. MR Tests included the following:
- RF heating- ASTM F2182-11a O
- o Image Distortion- ASTM F2119-07
- Magnetically Induced Displacement Force - O ASTM 2052-14
- o CEM43 analysis
- Testing has been performed to establish product nonpyrogenicity.
. Clinical Tests:
Clinical data was not provided for the subject devices.
Substantial Equivalence Conclusion:
Non-clinical tests provided in this Traditional 510(k) establish the conditional safety and compatibility of the
6
passive implants in a magnetic resonance (MR) environment. The subject devices are substantially equivalent to the legally marketed predicated devices.