(77 days)
Not Found
No
The description focuses on the mechanical and structural aspects of a modular prosthetic system for bone replacement, with no mention of AI or ML technologies.
Yes
The device is intended to replace parts of the femur, tibia, and patella due to severe bone loss or trauma, addressing conditions like metastatic diseases and degenerative joint disease. Its purpose is to restore function and alleviate symptoms, which aligns with the definition of a therapeutic device.
No
The device is described as a system for replacing parts of the femur, tibia, and patella, intended for extensive resections and restorations in cases like metastatic diseases. It is a prosthetic implant, not a tool used for diagnosis.
No
The device description clearly outlines physical components like proximal and distal femoral replacements, intramedullary stems, and an all-poly patella, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that this device is a prosthetic system intended to replace parts of the femur, tibia, and patella. It is a physical implant used in surgical procedures.
- Intended Use: The intended use is for surgical replacement of bone in cases of severe bone loss, trauma, or disease. This is a therapeutic intervention, not a diagnostic test.
The device is a surgical implant, not a diagnostic tool that analyzes samples.
N/A
Intended Use / Indications for Use
This device is intended to replace the proximal, distal or total femur, especially in cases that require extensive resection and restoration. Replacement of the distal femur would also include replacement of the proximal tibia and the possible resurfacing of the patella, if necessary. Proximal replacement components are available for press-fit or cemented application. Components used for replacement of the distal femur are for cemented use only. Specific diagnostic indications for use of the MOST include:
- metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell turnors, bone tumors) requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur;
- revision cases requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur: and.
- severe conditions of inflammatory or noninflammatory degenerative joint disease that require extensive resection(s) and replacentent(s) of the proximal and/or distal femur.
Product codes
Not Found
Device Description
The Modular Options for Severe bone loss and Trauma (MOST) System will be used for the replacement of the proximal, distal or total femur. Replacement of the distal femur would also include replacement of the proximal tibia and the possible resurfacing of the patella, if necessary, Unlike primary hip and knee systems, this system will be used where the amount of femoral resection and restoration required is extreme (e.g., in oncology cases). The modularity of this system allows for the resection of varying amounts of the femur (and the proximal tibia and patella, if necessary) before implantation. A total replacement is possible in those cases where no part of the femur can be salvaged. The components of the MOST System include:
the proximal femoral replacement that is available in two designs to address the presence or absence of the greater rochanter, with sunure holes for soft tissue attachment;
- the distal femoral replacement which mates with a tibial component via a hinge-type mechanism, allowing 15 degrees of internal and external rountion;
- intramedullary (I/M) stems with Cancellous Structured Titanium (CSTi) and femoral segments which will be used in conjunction with the proximal and distal replacements, and,
- an all-poly patella.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femur, proximal tibia, patella
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)
The Segmented Oncology System (S.O.S. 3) Proximal Femur (Wright Medical), MP Reconstruction Prosthesis (Link), Noiles Total Knee Prosthesis (Joint Medical Products Corporation), Kinematic II Rotating Hinge (Howmedica)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 an acetabular resurfacing 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
X964350
JAN 1 6 1997
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21CFR 807, this is to serve as a Model Devices The OF 5995 and The Modular Options for Severe bone loss and Trauma (MOST) System.
| Submitter: | Intermedics Orthopedics, Inc.
9900 Spectrum Drive
Austin, Texas 78717
(512) 432-9687 |
|-------------------------|------------------------------------------------------------------------------------------------------------------|
| Date: | January 10, 1997 |
| Contact Person: | Jacquelyn Hughes
Manager, Regulatory Affairs |
| Classification Name: | Knee joint femorotibial metal/polymer constrained
cemented prosthesis 21CFR 888.3510 |
| Classification Name: | Hip joint metal/ceramic/polymer semiconstrained
cemented or nonporous uncemented prosthesis 21CFR
888.3353 |
| Common/Usual Name: | Hinge Knee for Total Knee Replacement/Hip Stem for
Total Hip Replacements/Total Hip and Knee
Replacement |
| Trade/Proprietary Name: | Modular Options for Severe bone loss and Trauma
(MOST) System |
PRODUCT DESCRIPTION
The Modular Options for Severe bone loss and Trauma (MOST) System will be used for the replacement of the proximal, distal or total femur. Replacement of the distal femur would also include replacement of the proximal tibia and the possible resurfacing of the patella, if necessary, Unlike primary hip and knee systems, this system will be used where the amount of femoral resection and restoration required is extreme (e.g., in oncology cases). The modularity of this system allows for the resection of varying amounts of the femur (and the proximal tibia and patella, if necessary) before implantation. A total replacement is possible in those cases where no part of the femur can be salvaged. The components of the MOST System include:
the proximal femoral replacement that is available in two designs to address the presence 트 or absence of the greater rochanter, with sunure holes for soft tissue attachment;
- the distal femoral replacement which mates with a tibial component via a hinge-type I mechanism, allowing 15 degrees of internal and external rountion;
- intramedullary (I/M) stems with Cancellous Structured Titanium™ (CSTi™) and femoral 트 segments which will be used in conjunction with the proximal and distal replacements, and,
- an all-poly patella. BR
1
P. 03
DIAGNOSTIC INDICATIONS
This device is intended to replace the proximal, distal or total femur, especially in cases that require extensive resection and restoration. Replacement of the distal femur would also include replacement of the proximal tibia and the possible resurfacing of the patella, if necessary. Proximal replacement components are available for press-fit or cemented application. Components used for replacement of the distal femur are for cemented use only. Specific diagnostic indications for use of the MOST include:
- metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell turnors, bone tumors) 트 requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur;
- revision cases requiring extensive resection(s) and replacement(s) of the proximal and/or 1 distal femur: and.
- severe conditions of inflammatory or noninflammatory degenerative joint disease that 트 require extensive resection(s) and replacentent(s) of the proximal and/or distal femur.
SUBSTANTIAL EQUIVALENCE
The MOST System is substantially equivalent to products offered by Wright Medical Technology, Inc., Waldermar Link, Joint Medical Products Corporation and Howmedica, Inc. The Segmented Oncology System (S.O.S. 3) Proximal Femur (Wright Medical) and the MP Reconstruction Prosthesis (Link) are both modular stem designs which allow for necessary length This provides surgeon's with intraoperative flexibility in a variety of clinical adjustment. situations.
The Hinge-Type Knee of the MOST System is substantially equivalent to the Noiles Total Knee Prosthesis (Joint Medical Products Corporation) and the Kinematic II Rotating Hinge (Howmedica).