(76 days)
Not Found
Not Found
No
The device description focuses solely on the physical design and materials of a knee implant component, with no mention of software, algorithms, or data processing.
Yes
The device is a knee implant designed to articulate within the knee joint, indicating its use in replacing or augmenting a body part for therapeutic purposes.
No
Explanation: The device description clearly states it is a component of a total knee system, designed for articulation and fixation, which is a therapeutic rather than diagnostic function.
No
The device description clearly describes a physical implant made of UHMWPE, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: This section, which would typically describe how the device is used to diagnose or treat a condition based on in vitro analysis, is "Not Found".
- Device Description: The description clearly states that the device is a physical implant designed to articulate within the knee joint. It is a component of a total knee system.
- Anatomical Site: The device is used within the "Knee joint," which is an in-vivo (within the body) application, not an in-vitro (outside the body) application.
- Lack of IVD-related information: There is no mention of analyzing samples (blood, tissue, etc.), diagnostic purposes, or any of the typical characteristics of an IVD.
This device is a medical device used for surgical implantation, specifically a component of a total knee replacement system.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
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
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Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 Drive
Austin, TX 78717
(512) 432-9900 |
|----------------------|------------------------------------------------------------------------------------------------|
| Contact Person: | Jacquelyn Hughes
Manager, Regulatory Affairs |
| Classification Name: | Knee joint femorotibial metal/polymer semi-constrained
cemented 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