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The Apollo Knee System Single Lug Patella is designed to articulate with the various tibial and femoral components of the Apollo Total Knee System. The Single Lug Patella is a one piece component manufactured from ultra-high molecular weight polyethylene (UHMWPE, ASTM F648). The design incorporates a large, round, centrally placed, single lug on the back of the component for fixation. A concentric cement groove is incorporated into the stem of the single lug to aid in cement adhesion. A discontinuous dovetail cement groove has also been incorporated into the flat surface on the back of the patella to aid in achieving a bone cement "macro-lock" and to assist in rotational stability of the implant. The component will be available in a 28mm round design as well as 29mmX32mm, 32mmX35mm, and 35mmX38mm elliptically shaped design.
I am sorry, but the provided text does not contain the information required to answer your request. The document is a 510(k) summary for a medical device (Apollo Total Knee System Single Lug Patella) and focuses on product description and substantial equivalence, rather than detailing an acceptance criteria study with the specifics you've requested.
Therefore, I cannot provide:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication method for the test set.
- Information on a multi-reader, multi-case (MRMC) comparative effectiveness study or effect size.
- Information on a standalone algorithm performance study.
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510(k) SUMMARY
Image /page/0/Picture/1 description: The image shows two lines of text, "K960535" and "K960535", with the second line being bolder. Below the second line of text is the date "APR 23 1996". The text appears to be handwritten and scanned into a digital format.
February 5, 1996
In accordance with the Food and Drug Administration Interim Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21CFR 807, this is to serve as a 510(k) Summary for the Intermedics Orthopedics, Inc. Apollo Total Knee System Single Lug Patella.
| Submitter: | Intermedics Orthopedics, Inc.9900 Spectrum DriveAustin, TX 78717(512) 432-9900 |
|---|---|
| Contact Person: | Jacquelyn HughesManager, Regulatory Affairs |
| Classification Name: | Knee joint femorotibial metal/polymer semi-constrainedcemented prothesis, 21 CFR 888.3530. |
| Common/Usual Name: | Single Lug All-Polyethylene Patella |
| Trade/Proprietary: | Apollo Total Knee System Single Lug Patella |
Product Description/Substantial Equivalence:
The Apollo Knee System Single Lug Patella is designed to articulate with the various tibial and femoral components of the Apollo Total Knee System. The Single Lug Patella is a one piece component manufactured from ultra-high molecular weight polyethylene (UHMWPE, ASTM F648). The design incorporates a large, round, centrally placed, single lug on the back of the component for fixation. A concentric cement groove is incorporated into the stem of the single lug to aid in cement adhesion. A discontinuous dovetail cement groove has also been incorporated into the flat surface on the back of the patella to aid in achieving a bone cement "macro-lock" and to assist in rotational stability of the implant. The component will be available in a 28mm round design as well as 29mmX32mm, 32mmX35mm, and 35mmX38mm elliptically shaped design.
The Apollo Total Knee System Single Lug Patella is also similar to the Smith & Nephew Richards Genesis All-Poly Patella, the Zimmer Insall-Burstein II All-Poly Patella, the Johnson & Johnson PFC All-Poly Patella, the Biomet Maxim All-Poly Patella, the Biomet AGC All-Poly Patella, and the Orthomet Axiom All-Poly Patella
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.