(90 days)
Not Found
Not Found
No
The summary describes a mechanical implant for knee replacement and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
The device is described as a "partial replacement of the articulating surfaces of the knee" for various degenerative and post-traumatic conditions, indicating its use in treating a medical condition and restoring function.
No
The device description indicates it is an implant (Repicci II Unicondylar Knee components for surgical replacement), not a tool for diagnosing medical conditions. Its intended use is for treatment of knee degeneration, not diagnosis.
No
The device description clearly states it consists of physical components (femoral and tibial components made of cobalt alloy and polyethylene) intended for surgical implantation, indicating it is a hardware medical device, not software-only.
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: The description clearly states that this device is an implant intended for surgical implantation to replace parts of the knee joint. It is a physical component placed inside the body.
- Intended Use: The intended use describes the surgical procedure and the condition it addresses (degenerative knee disease), not a diagnostic test performed on a sample.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Partial replacement of the 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 device is a single use implant intended for implantation with bone cement.
Product codes
HRY
Device Description
The Repicci II Unicondylar Knee consists of femoral and tibial components. The femoral component is anatomic in design.to provide coverage of the condyle from posterior to anterior. The anatomic shape of the femoral component necessitates separate left and right configurations. A central keel and post on the back of the device assist in cement fixation. The device is manufactured from cobalt alloy.
Two styles of tibial components are available with this system, an all polyethylene component and a modular metal backed component. The all polyethylene component is universal in geometry. A waffle pattern on the under surface assists in initial fixation. A modular tibial component consists of a metal tray and a polyethylene bearing which is snap fit into the tray by the surgeon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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.
0
AUG 25 1997
Image /page/0/Picture/1 description: The image shows the logo for Biomet Inc. The logo is in black and white and features the company name in a stylized font. Above the logo is the number K97 1938. Below the logo is the text "CORPORATE HEADQUARTERS".
Summary of Safety and Effectiveness
Sponsor: Biomet. Inc. Airport Industrial Park P.O. Box 587 Warsaw. IN 46581-0578
Device: Repicci II Unicondylar Knee
Classification Name: Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/Polymer (21 CFR 888.3530)
Intended Use: Partial replacement of the 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 device is a single use implant intended for implantation with bone cement.
Device Description: The Repicci II Unicondylar Knee consists of femoral and tibial components. The femoral component is anatomic in design.to provide coverage of the condyle from posterior to anterior. The anatomic shape of the femoral component necessitates separate left and right configurations. A central keel and post on the back of the device assist in cement fixation. The device is manufactured from cobalt alloy.
Two styles of tibial components are available with this system, an all polyethylene component and a modular metal backed component. The all polyethylene component is universal in geometry. A waffle pattern on the under surface assists in initial fixation. A modular tibial component consists of a metal tray and a polyethylene bearing which is snap fit into the tray by the surgeon.
Potential Risks: The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:
Reaction to the bone cement Deformity of the joint Cardiovascular disorders Fracture of the cement Implant loosening/migration Nerve damage
Blood vessel damage Soft tissue imbalance Delayed wound healing Metal sensitivity Fracture of the components Bone fracture Infection Hematoma Dislocation Excessive wear
MAHING ADDRESS 120. Box 587 Warsaw, IN 46581 0587
트
SHIPPING ADDRESS Airport Industrial Park Warsaw, IN 46580
000030
()FFICE 219.267.6639
ドハメー 2191267.8137
E-MAIL biome!(@))ionnot.com
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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
•Ms. Patricia Sandborn Beres Director, Requlatroy Affairs BioMet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
AUG 25 1997
K971938 Re: Repicci II Unicondylar Knee Regulatory Class: II Product Code: HRY Dated: May 23, 1997 Received: May 27, 1997
Dear Ms. Beres:
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). This decision is based on this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone cement." You may, therefore, market your device subject to the general controls provisions of the Act and the following limitations:
- The thinnest tibial insert available is the nominal 1. "8.0mm" sized insert, which has a minimum polyethylene thickness under the condyles of 6.0mm.
- The thinnest all-poly tibial tray component available is 2. the nominal "8.5mm" sized component, which has a minimum polyethylene thickness under the condyles of 8.5mm.
- This device may not be labeled or promoted for 3 . non-cemented use.
- All labeling for this device, including package label 4 . and labeling included within the package, must prominently state that the device is intended for cemented use only.
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Paqe 2 - Ms. Patricia Sandborn Beres
- Any non-cemented fixation of this device is considered 5. investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulation under 21 CFR, Part 812. All users of the device for non-cemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Druq Administration (FDA) to conduct the investiqation.
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, 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 Requlations, 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 requlation (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 requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.
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
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Page 3 - Ms. Patricia Sandborn Beres
obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at at feb corr rree namber (0:1)/www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
C. R. M. Witter Ph. D. M
Na M. Witten, Ph.D., M.D. Ce Director Division of General and Restorative 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): _ 上971738_
Device Name: Repicci II Unicondylar Knee_
Indications For Use:
Partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or posttraumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.
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)
X Prescription Use_ (Per 21 CFR 801.109)
| OR | Over-The-Counter Use ______ |
|---|---|
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K971938 |
|---|---|
| --------------- | --------- |