(5 days)
No
The summary describes a physical implant (knee replacement components) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a medical implant intended to partially replace articulating surfaces of the knee due to degenerative disease or fractures, which is a therapeutic intervention.
No
Explanation: This device is a knee implant designed for surgical replacement of articulating surfaces, not for diagnosing medical conditions.
No
The device description clearly states that the device consists of femoral and tibial components, which are physical implants. It also mentions the use of bone cement and describes the physical characteristics of the tibial component (geometry, patterned face, holes, fin). This indicates a hardware medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing parts of the knee joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical components (femoral and tibial components, polyethylene tibial components) that are implanted into the body. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis, which are hallmarks of IVD devices.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HRY
Device Description
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.
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 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.
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.
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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JUN 1 3 2001
CORPORAT ARTERS
SUMMARY OF SAFETY AND EFFECTIVENESS
| Sponsor: | Biomet Orthopedics, Inc.
P.O. Box 587
Warsaw, 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
0
OFFICE 219.267.6639
FAX 219.267.8137
E-MAIL biomet@biomet.com
1
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.
2
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
3
of Page
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 |