(65 days)
Not Found
Not Found
No
The device description focuses on the mechanical and structural aspects of a modular orthopedic implant system. There is no mention of software, algorithms, data processing, or any terms related to AI or ML. The predicate devices are also traditional orthopedic implants.
Yes
The device is described as a replacement for the femur, including oncology cases, and is listed with predicate devices that are prostheses, indicating it is used to treat a medical condition.
No
The device, MOST, is described as a system for the replacement of parts of the femur, proximal tibia, and patella, primarily for oncology cases requiring extreme resection and restoration. This is a therapeutic (replacement) device, not a diagnostic one.
No
The device description clearly outlines a system of physical implants (proximal femoral replacement, intramedullary stems, femoral segments, distal femoral replacement, patella) used for surgical replacement of bone, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that the Modular Oncology System Technology (MOST) is a system for the replacement of bones (femur, proximal tibia, patella). This is a surgical implant, not a device that analyzes biological samples.
- Intended Use: While the "Intended Use / Indications for Use" section is "Not Found," the "Device Description" strongly indicates a surgical application for bone replacement in oncology cases.
Therefore, the MOST system is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
The Modular Oncology System Technology (MOST) 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. The components of the MOST include:
- 프 a proximal femoral replacement available with or without Cancellous-Structured Titanium" (CSTi ).
- 비 suture holes on the Proximal Femur provide for soft tissue attachment, if necessary,
- 미 intramedullary stems with CSTi and femoral segments which will be used in conjunction with the proximal and distal replacements,
- 해 the distal femoral replacement which mates with a tibial component via a hinge-type mechanism, 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)
Not Found
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
9/2012
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 Summary of Safety and Effectiveness for the Modular Oncology System Technology (MOST).
| Submitter: | Intermedics Orthopedics, Inc.
9900 Spectrum Drive
Austin, Texas 78717
(512) 432-9687 |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | February 12, 1996 |
| Contact Person: | Jacquelyn Hughes
Regulatory Affairs Manager |
| Classification Name: | Knee joint femorotibial metal/polymer constrained
cemented prosthesis 21CFR 888.3510
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 Oncology System Technology (MOST) |
PRODUCT DESCRIPTION/SUBSTANTIAL EQUIVALENCE
The Modular Oncology System Technology (MOST) 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. The components of the MOST include:
- 프 a proximal femoral replacement available with or without Cancellous-Structured Titanium" (CSTi ).
- 비 suture holes on the Proximal Femur provide for soft tissue attachment, if necessary,
- 미 intramedullary stems with CSTi and femoral segments which will be used in conjunction with the proximal and distal replacements,
- 해 the distal femoral replacement which mates with a tibial component via a hinge-type mechanism, and
- an all-poly patella.
3/6
1
The Modular Oncology System Technology 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. ) Proximal Femur (Wright Medical) and the MP Reconstruction Prosthesis (Link) are both modular stem designs which allow for necessary length adjustment. This provides surgeon's with intraoperative flexibility in a variety of clinical 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).