(112 days)
Not Found
No
The summary describes a physical medical device (tibial bearings) made of specific materials and intended for mechanical function in knee replacement surgery. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device, E-Poly™ Tibial Bearings, is an implantable component for knee joint replacement, intended to correct deformities and replace diseased joints. It is a prosthetic device used to restore function and alleviate pain, rather than a device that delivers therapy or treatment in an active manner.
No
The device, E-Poly™ Tibial Bearings, is a joint replacement component used to treat painful and disabled knee joints. Its function is to correct deformities and replace failed previous procedures, not to diagnose a condition.
No
The device description clearly states it is a physical component (tibial bearings) made of UHMWPE, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for surgical implantation to replace or correct issues in the knee joint. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details a physical implant (tibial bearings) made of specific materials for use within the body. This is consistent with a medical device for treatment, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information about a patient's condition based on in vitro testing.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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.
For cemented and un-cemented use.
Product codes
OIY, JWH, MBH, MBV
Device Description
The E-Poly™ Tibial Bearings are provided in five sizes. Each size comes in five thicknesses. (There are five basic styles of the E-Poly™ Bearings which are intended to be unsel with previously cleared Biomet knee products.)
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
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
K023546, K041046, K050222, K070364
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.
0
Image /page/0/Picture/0 description: The image shows the logo for BIOMET INC. The logo is in black and white, and the text is in a bold, sans-serif font. The letters are all capitalized, and the word "INC" is smaller than the word "BIOMET". The logo is simple and modern.
086528
JUN 1 7 2008
510(k) Summary E-Poly™ Tibial Bearings
| Preparation Date: | February 22, 2008 |
|---|---|
| Applicant/Sponsor: | Biomet Manufacturing Corp. |
| Contact Person: | Melissa Steinwedel |
| Regulatory Specialist | |
| Proprietary Name: | E-Poly™ Tibial Bearings |
| Common Name: | Vitamin E Polyethylene Tibial Bearings |
| Classification Name: | Cemented semi-constrained polymer/metal/polymer knee |
| prosthesis (888.3560), JWH |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
| Maxim Accel Knee System | K023546 | Biomet Inc. |
|---|---|---|
| Maxim Accel (Vanguard™) PS & Bearings | K041046 | Biomet Inc. |
| Vanguard™ Anterior Stabilized Tibial Bearings | K050222 | Biomet Inc. |
| 100kGy E-Poly™ MaxRom Acetabular Liners | K070364 | Biomet Inc. |
Device Description: The E-Poly™ Tibial Bearings are provided in five sizes. Each size comes in five thicknesses. (There are five basic styles of the E-Poly™ Bearings which are intended to be unsel with previously cleared Biomet knee products.)
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.
Intended Use:
For cemented and un-cemented use,
Summary of Technologies: The E-Poly™ UHMWPE tibial bearings are highly-crosslinked to improve wear resistance, and infused with vitamin E to stabilize free-radicals and prevent oxidative degradation.
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet
Pri Barces 11/2019 11/25/2017 11:51
5-1
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized image of an eagle.
UUL 2 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomet Orthopedics, Inc. % Mr. Gary Baker 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581
Re: K080528
Trade/Device Name: E-Poly Tibial Bearings Regulation Number: 21 CFR 888.3560 Regulation Name: Cemented semi-constrained polymer/metal/polymer knee prosthesis Regulatory Class: Class II Product Code: OIY, JWH, MBH, MBV Dated: June 4, 2008 Received: June 6, 2006
Dear Mr. Baker:
This letter corrects our substantially equivalent letter dated June 17, 2008.
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 (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, laheling, and prohibitions against misbranding and adulteration.
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); 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.
2
Page 2 - Mr. Gary Baker
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Indications for Use
510(k) Number (if known): KO80528
E-Poly™ Tibial Liners Device Name:
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.
For cemented and un-cemented use.
Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil Rbe Ogle
Division of General, Restorative, and Neurological Devices
510(k) Number K080528