(5 days)
Partial replacement of 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 Components.
The device is a single use implant intended for implantation w/ bone cement.
The Repicci IITM Unicondylar Knee System consists of a femoral and tibial component. The Worland tibial bearing is used with the Repicci II™ femoral components (K971938).
The all polyethylene tibial components are anatomical in geometry with right and left medial/lateral allocations. Located on the inferior surface of the implant is a patterned face with holes and a fin.
The provided document is a 510(k) summary for a medical device called the "Worland Unicondylar Tibial Bearing." This type of submission is for demonstrating substantial equivalence to a predicate device, not for a novel device requiring extensive clinical trials to prove efficacy against acceptance criteria. Therefore, most of the requested information (acceptance criteria, specific study details, ground truth, expert involvement, MRMC studies, etc.) is not applicable or available in this document.
Here's a breakdown based on the information provided:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of performance metrics. The underlying acceptance criteria for a 510(k) submission is "substantial equivalence" to a predicate device. This means the device is as safe and effective as a legally marketed device.
- Reported Device Performance:
- Non-Clinical Testing: "Fatigue testing and stress analysis determined that the Worland Unicondylar Tibular components presented no new risks and were; therefore, substantially equivalent to the predicate device."
- Clinical Testing: "None provided as a basis for substantial equivalence."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable. No clinical test set or data provenance is mentioned as substantial equivalence was based on non-clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. No clinical test set or ground truth was established. The "ground truth" for substantial equivalence was the predicate device's established safety and effectiveness.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication was performed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI-based device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the purpose of this 510(k) submission, the "ground truth" or benchmark for safety and effectiveness was the predicate device (Repicci II™ Unicondylar All Poly Tibial Bearing - K980665). The new device was deemed substantially equivalent based on similarities in materials, design, sizing, indications, and non-clinical testing results.
8. The sample size for the training set
- Not applicable. This is not a machine learning device, and no training set was used.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
In summary, this document describes a device (a unicondylar tibial bearing) seeking market clearance through the 510(k) pathway, which primarily relies on demonstrating substantial equivalence to an existing predicate device rather than novel clinical performance studies against specific acceptance criteria. The equivalence was established through non-clinical fatigue testing and stress analysis, showing no new risks compared to the predicate.
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JUN 1 3 2001
CORPORAT ARTERS
SUMMARY OF SAFETY AND EFFECTIVENESS
| Sponsor: | Biomet Orthopedics, Inc.P.O. Box 587Warsaw, IN 46581-0587 |
|---|---|
| Contact Person: | Tracy J. Bickel(219) 267-6639 |
| Proprietary Name: | Worland Unicondylar Tibial Bearing |
| Common Name: | Unicompartmental Knee Tibial Component |
Classification Name: Prosthesis, Knee, Femorotibial, semi-constrained, cemented, metal/polymer (21 CFR 888.350)
Substantially Equivalent Devices: Repicci II™ Unicondylar All Poly Tibial Bearing - K980665
The Repicci IITM Unicondylar Knee System consists of a femoral and tibial Device Description: component. The Worland tibial bearing is used with the Repicci II™ femoral components (K971938).
The all polyethylene tibial components are anatomical in geometry with right and left medial/lateral allocations. Located on the inferior surface of the implant is a patterned face with holes and a fin.
Intended Use: Partial replacement of 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 Components.
The device is a single use implant intended for implantation w/ bone cement.
Summary of Technologies: The Worland Unicondylar Tibial components materials, design, sizing, and indications are similar to or identical to the predicate devices.
Non-Clinical Testing: Fatigue testing and stress analysis determined that the Worland Unicondylar Tibular components presented no new risks and were; therefore, substantially equivalent to the predicate device.
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
D
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
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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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a human profile.
Public Health Service
JUN 1 3 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Tracy Bickel Regulatory Specialist Biomet, Inc 56 Bell Drive Warsaw, Indiana 46582
Re: K011795
Trade Name: Worland Unicondylar Tibial Bearing Regulation Number: 888.3560 Regulatory Class: II Product Code: HRY Dated: June 7, 2001 Received: June 8, 2001
Dear Ms. Bickel:
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. Tracy Bickel
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,
Bmt chelltmo for
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) Device Name: Worland Unicondylar Tibial Bearings Indications for Use:
Partial replacement of 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 Components.
The device is a single use implant intended for implantation with bone cement.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | Втыелмено от слиш |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative and Neurological Devices | |
| K011795 | |
| Prescription Use(Per 21 CFR 801.109) | OR |
| 510(k) Number Over-The-Counter Use(Optional Format 1-2-96) | |
| 000008 |
§ 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.