(425 days)
Not Found
No
The device description focuses on the materials and components of a knee endoprosthesis, with no mention of software, algorithms, or AI/ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device replaces a damaged knee joint to provide mobility and reduce pain, which are therapeutic benefits aimed at improving a patient's health and quality of life.
No
The device is an endoprosthesis for replacing a damaged knee joint, which is a therapeutic device, not a diagnostic one. Its purpose is to treat a condition by replacing a joint, not to diagnose a disease or condition.
No
The device description clearly outlines physical components made of materials like CoCr alloy and UHMWPE, which are hardware implants for knee replacement.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a knee endoprosthesis intended to be surgically implanted to replace a damaged knee joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of the implant (femoral components, tibial baseplate, tibial inserts, tibial spacers) which are all physical parts designed for surgical implantation.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) or to provide information about a patient's health status based on such testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
ÆQUOS- Knee- Endoprosthesis is intended to provide mobility and reduce pain by replacing the damaged knee joint articulation. Candidates for total knee joint includes patients with a severely painful and/or severly disabled joint resulting from different syndromes.
The indications are:
- . Damaged and seriously damaged and painful knee joints with relevant malfunction, instability or subluxation of the joint
- Therapy resistant bow contracture of more than 20° or non compensable . malposition of the anatomical axis from approximatly 15-20°
- Double sided joint anchylosis or anchylosis of the opposite hip joint ●
- All conservative therapies were unsuccessful or joint conserving operations . provide no success or have already failed
- Failure after implantation of monocondylar implants .
- Stiffening of the joint is contraindicated .
Product codes
87 JWH
Device Description
The ÆQUOS knee endoprosthesis consists of:
- Femoral components in anatomic and asymmetrical design a) manufactured from cast CoCr alloy (ASTM F75). Femoral components are intended for cemented use only.
- b) Tibial baseplate in anatomic design manufactured from cast CoCr alloy (ASTM F75). The tibial baseplate is a non-porous, stemmed configuration and intended for cemented use only.
- c) Tibial inserts in anatomic and asymmetrical design manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE)
- d) Tibial spacers
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint
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)
K000978, K023788, K024161, K023546
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
Image /page/0/Picture/1 description: The image is a blank white canvas with a few small, indistinct markings in the lower right corner. These markings appear to be composed of short, dark lines or dots, but their exact nature is unclear due to their small size and low resolution. The rest of the image is uniformly white, lacking any other discernible features or patterns.
000 Implantate /
*MEBIC
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitters Name: | aap Implantate AG |
|---|---|
| Lorenzweg 5 | |
| 12099 Berlin | |
| DEC - 7 2004 | Germany |
| Phone: +49 30 750 19 0 | |
| Fax: +49 30 750 19 111 | |
| Contact Name: | Marc Seegers, Director Quality Management |
| email: m.seegers@aap.de | |
| Name of Device: | ÆQUOS Knee Endoprosthesis cemented |
| Classification Name: | Knee joint patellofemorotibial |
| polymer/metal/polymer | |
| semi-constrained cemented prosthesis | |
| Common/Usual Name: | Knee-Endoprosthesis |
| Proprietary Name: | ÆQUOS-Knee- Endoprosthesis |
| Device Class: | Class II |
| Product Code: | 87 J WH |
| Classification: | CFR Chapter I, Title 21 § 888.3560 Knee joint |
| patellofemorotibial polymer/metal/polymer semi- | |
| constrained cemented prosthesis | |
| Review Panel: | Orthopaedics |
Performance Standards:
Devices are manufactured according to cGMP's, applicable ASTM requirements, and applicable harmonised standards ISO 9001 / EN 46001.
Material Composition:
ÆQUOS- Knee- Endoprosthesis components are manufactured of Cobalt Chromium Alloy (ASTM F75) and Ultra-High Molecular Weight PolyEthylene (ISO 5834-2)
Intended Use:
ÆQUOS- Knee- Endoprosthesis is intended to provide mobility and reduce pain by replacing the damaged knee joint articulation. Candidates for total knee joint includes patients with a severely painful and/or severly disabled joint resulting from different syndromes.
The indications are:
- . Damaged and seriously damaged and painful knee joints with relevant malfunction, instability or subluxation of the joint
- Therapy resistant bow contracture of more than 20° or non compensable . malposition of the anatomical axis from approximatly 15-20°
- Double sided joint anchylosis or anchylosis of the opposite hip joint ●
1
-
All conservative therapies were unsuccessful or joint conserving operations . provide no success or have already failed
CalB -
Failure after implantation of monocondylar implants .
K 033266 -
Stiffening of the joint is contraindicated .
The contra-indications are: -
Badly condition of the patient .
-
. Badly condition of the skin
-
Untreated malfunction of the metabolism .
-
Joint destruction caused by haemophilia, tabes or after infections .
-
Instability of the joint ligaments .
The ÆQUOS knee endoprosthesis is only for use with bone cement
Device Description:
The ÆQUOS knee endoprosthesis consists of:
- Femoral components in anatomic and asymmetrical design a) manufactured from cast CoCr alloy (ASTM F75). Femoral components are intended for cemented use only.
- b) Tibial baseplate in anatomic design manufactured from cast CoCr alloy (ASTM F75). The tibial baseplate is a non-porous, stemmed configuration and intended for cemented use only.
- c) Tibial inserts in anatomic and asymmetrical design manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE)
- d) Tibial spacers
Predicate Devices for Substantial Equivalence:
ÆQUOS is similar in size, material and intended use to the
- Anatomic Total Knee (K000978) of Biomet, Inc. .
- Columbus (CR) Total Knee System (K023788) of Aesculap, Inc. .
- Nexgen Complete Knee Solution Trabecular Metal (K024161) of Implex . Corp.
- Maxim Accel Knee System (K023546) of Biomet, Inc. .
Comparision of Technological Characteristics: Æquos is substantially equivalent to the predicate devices with respect to physical/technical and material characteristics.
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