(84 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 or ML.
Yes
The device is a partial knee replacement, which is explicitly designed to treat conditions like degenerative joint disease and fractures in the knee, thereby restoring function and alleviating symptoms. This fits the definition of a therapeutic device.
No
This device is a partial knee replacement, which is a prosthetic implant used to treat knee joint degeneration, not to diagnose a condition.
No
The device description clearly outlines physical components made of CoCrMo and polyethylene, which are hardware materials for a knee replacement. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this device is a partial knee replacement intended for surgical implantation to replace damaged articulating surfaces of the knee joint. This is an implantable medical device, not a diagnostic test performed on samples outside the body.
The information provided focuses on the physical components of the implant, its materials, sizes, and how it is intended to be used in a surgical setting to treat a physical condition of the knee. There is no mention of analyzing biological samples or providing diagnostic information.
N/A
Intended Use / Indications for Use
Unicondylar Knee implant intended to replace part of a knee joint when used in conjunction with a femoral and tibial component.
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 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 femoral and tibial tray components have a coarse grit blast surface finish the same as that of the predicates. The tibial component (metal tray plus polyethylene) will be available in 6 sizes (A, B, C, D, E and F) and 5 overall thicknesses (8.0, 9.0, 10.0, 11.0, 12.0mm). The subject tibial component is D-shaped. The subject device is indicated for lateral use only for cemented use fixation.
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)
Preclinical performance tests/rationales were provided to address the subject construct's Contact Area, Range of Motion, and Tibial Strength. A Magnetic Resonance rationale was also provided. 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.
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.
0
K1222277
. .
OCT 2 2 2012
. . . . .
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
| Submitter Information | |
|---|---|
| Name | Biomet Manufacturing Corp. |
| Address | 56 East Bell Drive |
| Warsaw, IN 46581-0857 | |
| Phone number | (574) 267-6639 |
| Fax number | (574) 372-1718 |
| Establishment | |
| Registration Number | 1825034 |
| Name of contact | |
| person | Elizabeth Wray |
| Date prepared | July 25, 2012 |
| 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 (21CFR §888.3530) | |
| Classification panel | Orthopedic |
| Regulation | 21CFR §888.3530 |
| Product Code(s) | HRY |
| Legally marketed | |
| device(s) to which | |
| equivalence is claimed | K042093 Vanguard M Series Unicondylar Tibial Bearings |
| K011138 Oxford Unicompartmental Knee Femoral Component | |
| Reason for 510(k) | |
| submission | New Device Construct |
| Device description | 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 femoral and tibial tray | |
| components have a coarse grit blast surface finish the same | |
| as that of the predicates. The tibial component (metal tray | |
| plus polyethylene) will be available in 6 sizes (A, B, C, D, E | |
| and F) and 5 overall thicknesses (8.0, 9.0, 10.0, 11.0, | |
| 12.0mm). The subject tibial component is D-shaped. The | |
| subject device is indicated for lateral use only for cemented | |
| use fixation. | |
| Intended use of the | |
| device | 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. |
! .
【
.
1
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. The tibial component is D-shaped for lateral use while the K042093 tibial component is tear shaped for lateral and medial use. Both the subject tibial component and the K042093 predicate incorporate a keel. The subject device is indicated only for cemented use fixation as in predicates. A tabular summary of the
2
| technological characteristics is provided below. | ||
|---|---|---|
| Characteristic | Subject Device | Predicate |
| Design - Femoral | Single and Twin Pegged Femorals | K011138 |
| Design - Tibial | D-Shaped | K042093 |
| Material | Co-Cr-Mo | |
| UHMWPE | K042093 | |
| K011138 | ||
| Principal of operation | Replace articulating surfaces of knee | K042093 |
| K011138 | ||
| Dimensions - Femoral | X-small, Small, Med, Large, X-Large | K011138 |
| Dimensions - Tibial | A, B, C, D, E, F | K042093 |
| Component | PERFORMANCE DATA |
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Performance Test Summary-New Device
The Oxford Fixed Lateral Partial Knee Replacement components have the same basic technological characteristics as the predicate devices except for slight modifications to the general design as described in this 510(k) notification. Preclinical performance tests/rationales were provided to address the subject construct's Contact Area, Range of Motion, and Tibial Strength. A Magnetic Resonance rationale was also provided. 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 results of preclinical tests/engineering rationales and the similarities with legally marketed devices indicate the devices will perform within the intended use, and do not raise any new safety and efficacy issues.
3
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Biomet Manufacturing Corp. % Ms. Elizabeth Wray Senior Regulatory Affairs Specialist P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K122277
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: II Product Code: HRY Dated: July 26, 2012 Received: July 30, 2012
Dear Ms. Wray:
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
OCT 2 2 2012
4
Page 2 – Ms. Elizabeth Wray
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K | 22277
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.
Prescription Use ___ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use __ NO (21 CFR 807 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ashb
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
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V122277 510(k) Number _