(88 days)
Not Found
No
The summary describes a mechanical knee implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
This device is an implantable prosthetic used for partial replacement of the knee joint's articulating surfaces, which is a restorative rather than a therapeutic function.
No
Explanation: The device description states it is a "Partial replacement of the articulating surfaces of the knee" and a "single use implant". These descriptions indicate it is a therapeutic device (an implant), not a diagnostic one.
No
The device description clearly describes a physical implant (femoral component and tibial components) intended for surgical implantation, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a surgical implant designed to replace parts of the knee joint. It is implanted directly into the body.
- Intended Use: The intended use is to replace articulating surfaces of the knee due to degenerative disease or revision of previous surgery. This is a treatment or reconstructive purpose, not a diagnostic one based on analyzing bodily specimens.
The device is clearly an orthopedic implant, not a diagnostic tool.
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, deformity or revision of previous arthroplasty. The device is a single use implant intended for implantation with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
HRY
Device Description
The Oxford™ Unicompartmental Knee Femoral Component has a highly polished spherical articular surface. The inner surface of the prosthesis is, for the most part, spherically concave and concentric with the articular surface. Posteriorly there is a small, flattened surface, the plane of which lies parallel to the long axis of the femur. There is a central peg. This ped lies parallel to the mechanical axis of the femur. The component is available in four distinct sizes to allow for fit to patient anatomy.
Two styles of Repicci™ tibial components may be used with the Oxford™ Unicompartmental Knee Femoral Component, an all polyethylene component and a modular metal backed component.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical and Clinical Testing: None provided as a basis for substantial equivalence. Engineering analysis conducted to show strength of peg.
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.
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
§ 888.3530 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.
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JUL 1 0 2001
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string appears to be "K011138". The characters are written in a simple, somewhat crude style, with varying stroke thicknesses. The overall impression is that of a quickly written or informal label.
Image /page/0/Picture/2 description: The image shows the logo for Biomet Inc. above the words Corporate Headquarters. The logo is in a bold, sans-serif font and is black in color. The words "Corporate Headquarters" are in a smaller, serif font and are also black in color. The image is simple and professional.
Summary of Safety and Effectiveness
| Applicant/Sponsor: | Biomet Orthopedics, Inc.
P.O. Box 587
Warsaw, Indiana 46581-0587 |
| -------------------- | ------------------------------------------------------------------------ |
|---|
Contact Person: Patricia Sandborn Beres (219) 267-6639
Proprietary Name: Oxford™ Unicompartmental Knee Femoral Component
Common Name: Unicompartmental Knee Femoral Component
Classification Name: Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, MetalPolymer (21 CFR 888.3530)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Repicci™ II Unicondylar Knee (K971938) and AGC® Unicompartmental Femoral Component (K873601)
Device Description: The Oxford™ Unicompartmental Knee Femoral Component has a highly polished spherical articular surface. The inner surface of the prosthesis is, for the most part, spherically concave and concentric with the articular surface. Posteriorly there is a small, flattened surface, the plane of which lies parallel to the long axis of the femur. There is a central peg. This ped lies parallel to the mechanical axis of the femur. The component is available in four distinct sizes to allow for fit to patient anatomy.
Two styles of Repicci™ tibial components may be used with the Oxford™ Unicompartmental Knee Femoral Component, an all polyethylene component and a modular metal backed component.
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, deformity or revision of previous arthroplasty. The device is a single use implant intended for implantation with bone cement.
Summary of Technologies: The Oxford™ Femoral component technological characteristics (materials, design, sizing, and indications) are similar to or identical to the predicate devices.
Non-Clinical and Clinical Testing: None provided as a basis for substantial equivalence. Engineering analysis conducted to show strength of peg.
All trademarks are property of Biomet, Inc.
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
지
SHIPPING ADDRESS Airport Industrial Park Warsaw, IN 46580
1
OFFICE 219.267.6639
FAX 219.267.8137
E-MAIL biomet@biomet.com
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Image /page/1/Picture/1 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 a stylized symbol that resembles three wavy lines or ribbons, possibly representing people or services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 0 2001
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet, Inc P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K011138
Trade Name: Oxford Unicompartmental Knee Femoral Component Regulatory Class: II Regulation Number: 888.3530 Product Code: HRY Dated: April 12, 2001 Received: April 13, 2001
Dear Ms. Beres:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
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Page 2 - Ms. Patricia Sandborn Beres
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Q. Mark N. Milken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known) K61138
Device Name: Oxford™ Unicompartmental Knee Femoral 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, deformity or revision of previous arthroplasty. The device is a single use, cemented implant
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Evaluation (ODE)
Mark N Milkerson
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number K 011138
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)