(23 days)
No
The summary describes a mechanical implant and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as an implantable component for partial knee replacement, which is a treatment for a medical condition rather than a diagnostic or monitoring tool.
No
This device is an implantable knee system used for partial replacement of the knee joint. Its intended use is to treat degenerative or post-traumatic diseases affecting one side of the knee joint, as well as deformities or revisions of previous arthroplasty. It is a treatment device, not a diagnostic one.
No
The device description clearly states that the device is an implantable knee system consisting of physical components (femoral and tibial components, tibial bearing). 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:
- Intended Use: The intended use describes a surgical implant for replacing parts of the knee joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as an all-polyethylene tibial component with a keel and fixation holes, designed for implantation with bone cement. This is consistent with a surgical implant.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on in vitro analysis.
- Anatomical Site: The anatomical site is the knee, which is where the implant is placed, not where a diagnostic test would be performed.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a physical implant used to treat a condition, not to diagnose it.
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
HRY
Device Description
The Repicci II® Unicondylar Knee System consists of a femoral and tibial component. The Repicci™ tibial bearing is used with the Repicci™ 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 face with fixation holes and a keel.
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: An engineering justification determined that the Repicci™ Locked Keel tibial 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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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BIOMET
030446
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SUMMARY OF SAFETY AND EFFECTIVENESS
| Sponsor: | Biomet Orthopedics, Inc.
P.O. Box 587
Warsaw, IN 46581-0587 | MAR 0 6 2003 |
|-------------------|-------------------------------------------------------------------|--------------|
| Contact Person: | Tracy J. Bickel
(574) 267-6639 | |
| Proprietary Name: | Repicci™ Locked Keel 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: Worland Unicondylar All Poly Tibial Bearing -- K011795
The Repicci II® Unicondylar Knee System consists of a femoral and tibial Device Description: component. The Repicci™ tibial bearing is used with the Repicci™ 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 face with fixation holes and a keel.
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 with bone cement.
Summary of Technologies: The Repicci™ Locked Keel Tibial components materials, design, sizing, and indications are similar to, or identical to the predicate devices. This submission modifies the keel on the inferior surface of the implant and removes the waffle pattern.
Non-Clinical Testing: An engineering justification determined that the Repicci™ Locked Keel tibial 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.
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MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587 SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
()FFICE 574.267.6639
FAX 574.267.8137
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 features a stylized eagle head in profile, composed of three curved lines. The eagle faces right, and the lines suggest feathers and the shape of the head. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
MAR 0 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Tracy J. Bickel Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw. Indiana 46581-0587
Re: K030446
Trade/Device Name: Repicci™ Locked Keel Tibial Bearing Regulation Number: 21 CFR 888.3530 Regulation Names: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: HRY Dated: February 7, 2003 Received: February 11, 2003
Dear Ms. Bickel:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); good manufacturing practice requirements as set
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Page 2- Ms. Tracy J. Bickel
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. This letter will allow you to begin marketing your device as described in your Section 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Mark A. Mulkerson
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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Page 1 of 1
510(k) Number (if known): Device Name: Repicci™ 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.
for Mark A. Mulkerson
Di ision of General, Restorative and Neurological Devices
KO30446 710(k) Number _
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)