(95 days)
Not Found
No
The summary describes a mechanical knee replacement device and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a "Partial Knee Replacement" intended to replace damaged articulating surfaces of the knee, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is described as a partial knee replacement, which is a therapeutic device intended for implantation to replace articulating surfaces of the knee, not to diagnose a condition.
No
The device description explicitly states it consists of physical components (femoral component, tibial tray/plate, tibial bearing) made from materials like CoCrMo and polyethylene, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes a surgical implant used to replace parts of the knee joint. It is implanted directly into the body to restore function.
- Lack of Diagnostic Activity: There is no mention of testing samples, analyzing biological markers, or providing diagnostic information based on in vitro analysis.
This device falls under the category of a surgical implant or prosthetic device, not an IVD.
N/A
Intended Use / Indications for Use
Indications For Use: Partial replacement of the articulating surfaces of the knee when only one side of the knee joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous partial arthroplasty in the affected compartment.
The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implanted with bone cement.
The Oxford Femoral components are indicated for use in the lateral compartment for a fixed bearing application. They are intended to be implanted with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
HRY
Device Description
The Oxford Fixed Lateral Bearing Partial Knee Replacement is a partial knee replacement option that consists of a femoral component (single and twin peg versions) manufactured from CoCrMo (ASTM F-75), a tibial tray/plate manufactured from CoCrMo (ASTM F-75), and a fixed tibial bearing of direct compression molded (DCM) polyethylene (UHMWPE) conforming to ASTM F-648 which is molded onto the tibial tray.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint, lateral compartment
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 performance testing included cadaver evaluation and MRI justification.
Results indicate that the subject construct is substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness.
Clinical Performance Data/Information: None provided as a basis for substantial equivalence.
The subject Oxford Fixed Lateral Bearing Partial Knee Replacement devices have been shown to be substantially equivalent to the predicate devices (K122277). Results of preclinical tests/engineering justification/cadaver evaluation and the similarities with legal marketed predicated devices indicate the device will perform within the intended use and no new issues of safety or effectiveness have been raised.
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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Image /page/0/Picture/2 description: The image shows the logo for Biomet Manufacturing Corp. The word "BIOMET" is in a stylized, blocky font, with a registered trademark symbol in the upper right corner. Below the logo, the words "MANUFACTURING CORP." are printed in a simple, sans-serif font.
,
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
| Applicant / Sponsor | |
|---|---|
| Name | Biomet UK, Ltd. |
| Address | Waterton Industrial Estate |
| Bridgend, United Kingdom CF31 3XA | |
| Establishment | |
| Registration Number | 3002806535 |
| Name of contact | |
| person | Jason Heckaman |
| Regulatory Affairs Project Manager | |
| Phone number | (574) 371-3707 |
| Fax number | (574) 372-1683 |
| Date prepared | December 20, 2013 |
| Name of device | |
| Trade or proprietary | |
| name | Oxford® Fixed Lateral Bearing Partial Knee Replacement |
| Common or usual | |
| name | Unicondylar Knee Prosthesis |
| Classification name | Knee joint femorotibial metal/polymer semi-constrained |
| cemented prosthesis (21 CFR §888.3530) | |
| Classification panel | Orthopedic |
| Regulation | 21 CFR §888.3530 |
| Product Code(s) | HRY |
| Legally marketed | |
| device(s) to which | |
| equivalence is claimed | K122277 Oxford Fixed Lateral Bearing Partial Knee |
| Replacement | |
| Reason for 510(k) | |
| submission | Modification to tibial bearing design |
| Device description | The Oxford Fixed Lateral Bearing Partial Knee Replacement |
| is a partial knee replacement option that consists of a | |
| femoral component (single and twin peg versions) | |
| manufactured from CoCrMo (ASTM F-75), a tibial tray/plate | |
| manufactured from CoCrMo (ASTM F-75), and a fixed tibial | |
| bearing of direct compression molded (DCM) polyethylene | |
| (UHMWPE) conforming to ASTM F-648 which is molded | |
| onto the tibial tray. | |
| Intended use of the device | The subject of this submission is a design modification to add a chamfer to the anterior corner of the tibial bearing, resulting in asymmetric left and right configurations rather than the symmetrical design cleared in K122277. |
| Unicondylar Knee implant intended to replace part of a knee joint when used in conjunction with a femoral and tibial component. | |
| Indications for use | Partial replacement of the articulating surfaces of the knee when only one side of the knee joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous partial arthroplasty in the affected compartment. |
The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implanted with bone cement.
The Oxford Femoral components are indicated for use in the lateral compartment for a fixed bearing application. They are intended to be implanted with bone cement. |
| Summary of the technological characteristics of the device compared to the predicate | |
| The Oxford Fixed Lateral Bearing Partial Knee Replacement is a partial knee replacement option that consists of a legally marketed femoral component (single and twin peg versions) manufactured from CoCrMo (ASTM F-75), a tibial tray/plate manufactured from CoCrMo (ASTM F-75), and a fixed tibial bearing of direct compression molded (DCM) polyethylene (UHMWPE) conforming to ASTM F-648 which is molded onto the tibial tray. The biocompatible materials of the components are identical to the predicates and have a long history of orthopedic use. Both the subject and predicate tibial components are D-shaped for lateral use, incorporate the same tibial tray keel, and are offered in the same sizes. The subject tibial bearing differs slightly from the K122277 bearing in that the subject design has been modified to include an anterior chamfer to reduce the likelihood of femoral impingement. The subject and predicate devices are both indicated only for cemented use fixation. | |
| PERFORMANCE DATA | |
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF
SUBSTANTIAL EQUIVALENCE | |
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MANUFA CORP.
Non-clinical performance testing included cadaver evaluation and MRI justification.
----.
P BB BB BAR BART PERSET PERSET
MERCER ME SERTEMENT SECT
MERCERS SECT
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Image /page/2/Picture/1 description: The image shows the logo for Biomet Manufacturing Corp. The logo consists of the word "BIOMET" in a stylized font, with the words "MANUFACTURING CORP." underneath. The text is in black and the background is white. The logo is simple and professional.
Results indicate that the subject construct is substantially equivalent to legally marketed devices offering a reasonable assurance of safety and effectiveness.
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
Clinical Performance Data/Information: None provided as a basis for substantial equivalence.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The subject Oxford Fixed Lateral Bearing Partial Knee Replacement devices have been shown to be substantially equivalent to the predicate devices (K122277). Results of preclinical tests/engineering justification/cadaver evaluation and the similarities with legal marketed predicated devices indicate the device will perform within the intended use and no new issues of safety or effectiveness have been raised.
Santa DI 2808 Liver Unen Far 574 267 8137
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image contains the words "Public Health Service" in bold, black font. The text is horizontally aligned and appears to be part of a title or heading. The background is plain and white, providing a clear contrast to the text.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 28, 2014
Biomet, Incorporated Jason Heckaman Regulatory Affairs Project Manager 56 East Bell Drive Warsaw, Indiana 46581
Re: K133940
Trade/Device Name: Oxford® Fixed Lateral Bearing Partial Knee Replacement 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: March 7, 2014 Received: March 10, 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. Ilsting 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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
- for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K133940 510(k) Number (if known): _
Device Name: Oxford Fixed Lateral Bearing Partial Knee Replacement
Indications For Use:
Partial replacement of the articulating surfaces of the knee when only one side of the knee joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous partial arthroplasty in the affected compartment.
The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implanted with bone cement.
The Oxford Femoral components are indicated for use in the lateral compartment for a fixed bearing application. They are intended to be implanted with bone cement.
AND/OR
Prescription Use × (Part 21 CFR 801 Subpart D) 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)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
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