(75 days)
Not Found
No
The document describes a mechanical knee implant system and manufacturing process modifications. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is a component of a total knee implant system used to replace a damaged or diseased knee joint, which is a restorative rather than therapeutic function.
No
The device is a Biomet Tibial Tray, which is a modular component of a total knee implant system used to replace damaged or diseased knee joints. It is an implantable surgical device, not a diagnostic tool.
No
The device description clearly indicates it is a physical implant (tibial trays) and associated instrumentation (CementON Tibial Molds), not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Biomet Tibial Trays are "modular components that are part of a total knee implant system intended to replace the damaged or diseased knee joint during total knee arthroplasty." This describes a surgical implant used in vivo (within the body) to treat a physical condition.
- Device Description: The description details the physical components of the implant (trays, augments, coatings) and manufacturing processes. This aligns with a medical device intended for surgical implantation.
- 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) to provide information for diagnosis, monitoring, or screening.
Therefore, the Biomet Tibial Trays are a medical device (specifically, a surgical implant), not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
-
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, 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 and uncemented biological fixation application. Non-coated (Interlok) devices and allpolyethylene patellar components are indicated for cemented application only.
Regenerex components are intended only for uncemented biologic fixation application.
Product codes
JWH, MBH, MBV
Device Description
The subject Biomet Tibial Trays are available in four design configurations – Interlok, porous, stemmed, and offset. The trays, as a system construct, are compatible with existing, legally marketed Biomet femoral components, tibial bearings, patella components, stems, and various auxiliary components, including augment blocks and wedges.
This submission includes a modification to remove the shot peen operation from the manufacturing process of the subject Biomet Tibial Trays. In addition, a new cementing technique option is being introduced for the Interlok tibial trays. The technique is executed via use of new implant-specific instrumentation referred to as CementON Tibial Molds.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
- Tibial Tray Cyclic Fatigue Testing
- I-beam Implant Pullout Force from a Cement Mantle after CementON or Manual Cement Application
- Finned Implant Pullout Force from a Cement Mantle after CementON or Manual Cement Application
Clinical Tests
- Clinical data was not required to establish substantial equivalence between the subject Biomet Tibial Trays and the predicate device.
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
§ 888.3560 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features the department's emblem, which is a stylized representation of a human figure in profile, repeated three times and arranged in a way that suggests movement or progress. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 23, 2014
Biomet, Incorporated Mr. Jason Heckaman Project Manager, Regulatory Affairs 56 East Bell Drive Warsaw, Indiana 46581
Re: K142933 Trade/Device Name: Biomet Tibial Trays Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis. Regulatory Class: Class II Product Code: JWH, MBH, MBV Dated: October 27, 2014 Received: October 28, 2014
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 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
1
the quality systems (OS) 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 yours,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/1 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are all capitalized and appear to be a dark gray or black color. The word is horizontally oriented and centered in the image.
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K142933
Device Name: Biomet Tibial Trays
INDICATIONS FOR USE:
-
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, 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 and uncemented biological fixation application. Non-coated (Interlok) devices and allpolyethylene patellar components are indicated for cemented application only.
Regenerex components are intended only for uncemented biologic fixation application.
Prescription Use |X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off) Division of Orthopedic Devices 510(k) Number: K142933
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Image /page/3/Picture/1 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are all capitalized and appear to be a dark gray or black color. The word is presented in a straightforward, unadorned manner, emphasizing its legibility and impact.
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 Tibial Trays 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: 1825034 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jason Heckaman
Project Manager, Regulatory Affairs
Phone: 574-371-3707
Fax: 574-372-1683 |
| Date: | October 30, 2014 |
| Subject Device: | Trade Name: Biomet Tibial Trays
Common Name: Knee Prosthesis
Classification Name:
• JWH - prosthesis, knee, patellofemorotibial, semi-constrained,
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)
• MBV-prosthesis, knee, patellofemorotibial, semi-constrained,
UHMWPE, pegged, cemented, polymer/metal/polymer (21 CFR §888.3560) |
Legally marketed devices to which substantial equivalence is claimed:
- K915132 MCK (Maximum Congruent Knee) System
- K010212 Offset Tibial Tray
- K033489 Biomet's Non-Cemented Porous Coated Knee Components
Device Description
The subject Biomet Tibial Trays are available in four design configurations – Interlok, porous, stemmed, and offset. The trays, as a system construct, are compatible with existing, legally marketed Biomet femoral components, tibial bearings, patella components, stems, and various auxiliary components, including augment blocks and wedges.
This submission includes a modification to remove the shot peen operation from the manufacturing process of the subject Biomet Tibial Trays. In addition, a new cementing
4
technique option is being introduced for the Interlok tibial trays. The technique is executed via use of new implant-specific instrumentation referred to as CementON Tibial Molds.
Intended Use and Indications for Use
Biomet Tibial Trays are modular components that are part of a total knee implant system intended to replace the damaged or diseased knee joint during total knee arthroplasty.
Indications for use are as follows:
-
- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, 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 and uncemented biological fixation application. Non-coated (Interlok) devices and allpolyethylene patellar components are indicated for cemented application only.
Regenerex components are intended only for uncemented biologic fixation application.
Summary of Technological Characteristics
The subject changes include removal of the shot peen operation from the manufacturing process and the addition of a new cementing technique option for the Interlok trays via use of new implant-specific instrumentation.
The subject modifications do not result in any changes to the intended use, indications for use, materials, design features, or sterilization of the Biomet Tibial Trays.
Summary of Performance Data (Nonclinical and/or Clinical)
- . Non-Clinical Tests
- o Tibial Tray Cyclic Fatigue Testing
- I-beam Implant Pullout Force from a Cement Mantle after CementON or Manual o Cement Application
- Finned Implant Pullout Force from a Cement Mantle after CementON or Manual o Cement Application
- . Clinical Tests
- Clinical data was not required to establish substantial equivalence between the o subject Biomet Tibial Trays and the predicate device.
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Image /page/5/Picture/1 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are all capitalized and evenly spaced. The color of the text is a dark gray, and the background is white.
Substantial Equivalence Conclusion
Based on the similarities in design, function, intended use and fundamental scientific technology, the devices that are the subject of this submission are similar to the predicate devices and do not introduce any new risks of safety or efficacy. Therefore, Biomet concludes that the subject devices are substantially equivalent to the predicate devices.