(89 days)
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 devices covered by this 510(k) are intended to be used with a Repicci Femoral component.
The device is a single use implant intended for implantation with bone cement.
The Repicci II Unicondylar Knee system consists of a femoral and tibial component. The femoral components have been cleared through a previous 510(k) as have thicker sizes of the all poly tibial component.
The all polvethylene tibial component is universal in geometry so separate components are not necessary for left and right knees. A waffle pattern and recessed holes on the under surface assists in fixation with bone cement. Due to the radiolucency of polyethylene, a wire is molded within the component.
The provided text is a Summary of Safety and Effectiveness for the Biomet Repicci II Unicondylar Knee All Poly Tibial Components, along with an FDA clearance letter. This type of document is a pre-market notification (510(k)) and primarily focuses on demonstrating substantial equivalence to a previously legally marketed device, rather than proving a device meets specific acceptance criteria through a standalone study with detailed performance metrics.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, MRMC studies, and standalone performance is not present in the provided text, as these are typically part of a clinical trial or performance study, which is not the primary purpose of a 510(k) submission for this type of device.
The document states that "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...". This means the FDA found it equivalent to similar devices already on the market based on its intended use, design principles, and materials, without requiring new, independent performance data against specific acceptance criteria like you would find for a novel diagnostic AI algorithm.
However, I can extract information related to the device and its intended use, which are implicitly part of the "acceptance" for market clearance:
1. A table of acceptance criteria and the reported device performance:
Since specific quantitative acceptance criteria and performance data from a dedicated study are not presented, I cannot create this table as requested. The "performance" demonstrated for a 510(k) is typically by demonstrating equivalence to a predicate device in terms of materials, design, and intended use, rather than achieving specific numerical performance thresholds in a clinical study for this type of implant.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. The document does not describe a "test set" or a study designed to evaluate performance metrics. It's a 510(k) submission for substantial equivalence.
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 "test set" and no related ground truth establishment by experts are described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No "test set" or adjudication method are described.
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 diagnostic device, and no MRMC comparative effectiveness study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No study requiring ground truth is described.
8. The sample size for the training set:
Not applicable. This is a physical implant, not a machine learning model, so there's no concept of a "training set" in the context of the provided document.
9. How the ground truth for the training set was established:
Not applicable. There is no training set involved.
Summary of what IS available in the document regarding "acceptance" for market clearance:
- Intended Use (Implicit Acceptance Criteria for Market Clearance): The device is intended for "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."
- Design and Materials (Implicit Acceptance Criteria for Market Clearance): The device is an all-polyethylene tibial component, universal in geometry, with a waffle pattern and recessed holes for cement fixation, and a molded wire for radiolucency. It is intended for use with a Repicci Femoral component.
- Safety (Implicit Acceptance Criteria for Market Clearance): The potential risks are acknowledged to be "the same as with any joint replacement device."
- Clinical Performance (Implicit Acceptance Criteria for Market Clearance): The FDA clearance is based on the device being "substantially equivalent" to predicate devices already on the market, implying that its performance is expected to be comparable and acceptable based on the history of those predicate devices. No new clinical performance study is detailed in this document.
- Specific Limitations/Conditions for Market Clearance from the FDA:
- Thinnest tibial component is nominal 6.5mm, with a minimum polyethylene thickness of 6.5mm.
- May not be labeled or promoted for non-cemented use.
- All labeling must prominently state that it is for cemented use only.
- Non-cemented fixation is considered investigational and requires IDE regulations (21 CFR, Part 812) and IRB/FDA approval.
In conclusion, the document is a 510(k) pre-market notification that demonstrates substantial equivalence, not a clinical study report with detailed performance metrics against specific acceptance criteria.
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Image /page/0/Picture/1 description: The image shows the logo for Biomet INC. The logo is in black and white and features the word "BIOMET" in a stylized font. Below the logo, the words "CORPORATE HEADQUARTERS" are written in a smaller font. The logo is simple and modern, and the overall image is clean and professional.
Summary of Safety and Effectiveness
Sponsor: Biomet. Inc. Airport Industrial Park P.O. Box 587 Warsaw, IN 46581-0578
Repicci II Unicondylar Knee All Poly Tibial Components Device:
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. The devices covered by this 510(k) are intended to be used with a Repicci Femoral component.
Device Description: The Repicci II Unicondylar Knee system consists of a femoral and tibial component. The femoral components have been cleared through a previous 510(k) as have thicker sizes of the all poly tibial component.
The all polvethylene tibial component is universal in geometry so separate components are not necessary for left and right knees. A waffle pattern and recessed holes on the under surface assists in fixation with bone cement. Due to the radiolucency of polyethylene, a wire is molded within the component.
Potential Risks: The potential risks associated with this device are the same as with any ioint 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
MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
1
SHIPPING ADDRESS Airport Industrial Park Warsaw, IN 46580
OFFICE 219.267.6639
FAX
219.267.8137
000027
E-MAIL biomet@biomet.com
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Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 20 1998
Ms. Patricia Sandborn Beres Director, Regulatory Affairs Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587
Re : K980665 Repicci II Unicondylar Knee All Poly Tibial Components Regulatory Class: II Product Code: HRY February 18, Dated: 1998 February 20, 1998 Received:
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 component available is the nominal 1. "6.5mm" sized component, which has a minimum polyethylene thickness of 6.5mm
-
- This device may not be labeled or promoted for noncemented use.
-
- All labeling for this device, including package label and labeling included within the package, must prominently state that the device is intended for cemented use only.
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Page 2 - Ms. Patricia Sandborn Beres
- Any non-cemented fixation of this device is considered র্ব . 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 noncemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Drug 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. ದ 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 In addition, FDA may publish further announcements action. 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 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 addition ly 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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obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/1 description: The image shows a handwritten alphanumeric string. The string is "K980665". The characters are written in a cursive style with thick, dark lines, suggesting they were written with a marker or pen.
510 (k) Number (if known) : _
Device Name: Repicci II Unicondylar Knee All Poly Tibial Components_
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 devices covered by this 510(k) are intended to be used with a Repicci Femoral component .
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 NEEDBO)
Concurrence of CDRH, Office of Device - Juation (ODE)
| Prescription Use | X | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K980665 |
|---|---|
| --------------- | --------- |
§ 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.