(126 days)
None
No
The description focuses on the mechanical components and intended use for knee replacement, with no mention of AI/ML, image processing, or data-driven performance metrics.
Yes
The device is an orthopedic implant (partial knee replacement) used to treat degenerative knee conditions, which directly addresses a health problem.
No
The device is a knee implant intended for partial replacement of articulating surfaces, not for diagnosing medical conditions.
No
The device description clearly states it is a physical implantable device made of UHMWPE and metal, intended for surgical implantation in the knee. It is 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 surgical implant for the knee joint to replace damaged articulating surfaces. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is a physical implant made of UHMWPE and metal, designed to be surgically implanted. This is consistent with a medical device for treatment, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Anatomical Site: The device is used directly on the knee joint, which is a part of the body, not a sample taken from the body for analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.
The devices covered in this 510(k) are intended to be used with Repicci Femoral component. The device is intended to be used with bone cement.
Product codes
HRY
Device Description
The Repicci II® Metal Back Inlay Unicompartmental Tibial component comprised of ultra-high molecular polyethylene (UHMWPE), with a thin corrugated metal plate molded into the inferior surface of the device. The tibial components are available in six profiles and two thicknesses and is intended for cemented fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
BIOMET
KO61681
510(k) Summary
| Preparation Date: | June 9, 2006 |
|---|---|
| Applicant/Sponsor: | Biomet Manufacturing Corp. |
| P.O. Box 587 | |
| Warsaw, Indiana 46581-0587 | |
| Contact Person: | Lester F. Padilla |
| Proprietary Name: | Repicci II® Metal Back Inlay Unicompartmental Tibial Bearing Component |
| Common Name: | Tibial component for uni-condylar knee replacement |
| Classification Name: | Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis |
| (21 CFR 888.3530) | |
| OCT 19 2006 |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
-
- Repicci II® Unicondylar Knee (K971938)
-
- Repicci III® Unicondylar Knee All Poly Tibial Components (K980665)
Device Description:
The Repicci II® Metal Back Inlay Unicompartmental Tibial component comprised of ultra-high molecular polyethylene (UHMWPE), with a thin corrugated metal plate molded into the inferior surface of the device. The tibial components are available in six profiles and two thicknesses and is intended for cemented fixation.
Intended Use:
Partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. The devices covered in this 510(k) are intended to be used with Repicci Femoral component. The device is intended to be used with bone cement.
Summary of Technologies: The technological characteristics (material, design, sizing, and indications) of the Repicci II® Metal Back Inlay Unicompartmental Tibial Bearing Component are similar or identical to the predicate devices.
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, Inc.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
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SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
OFFICE 574.267.6639
FAX
574.267.8137
E-MAH. biomet@biomet.com
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomet. Inc. % Lester F. Padilla, RAC Regulatory Affairs Associate P.O. Box 587 56 East Bell Drive Warsaw, Indiana 46581
OCT 1 9 2006
Re: K061681
Trade/Device Name: Repicci II® Metal Back Inlay Unicompartmental Tibial Bearing Component Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HRY Dated: September 18, 2006 Received: September 21, 2006
Dear Mr. Padilla:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Lester F. Padilla
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 Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
To My Son
Mark N. Melkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name: Repicci II® Metal Back Inlay Unicompartmental Tibial Bearing Component
Indications for Use:
Partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.
The devices covered in this 510(k) are intended to be used with Repicci Femoral component.
The device is intended to be used with bone cement.
Prescription Use _________X (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)
Page 1 of 1
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number_ L001141