(338 days)
No
The device description and intended use are purely mechanical, and there is no mention of AI, ML, or any related technologies in the provided text.
Yes
The device is an implantable system intended for the fixation of various types of femoral fractures, which clearly indicates a therapeutic purpose.
No
The device, TRUE/FIT™ Femoral Intramedullary Rod System, is described as an implantable device for the fixation of various types of femoral fractures, which indicates a therapeutic purpose rather than a diagnostic one.
No
The device description explicitly lists physical components made of Ti-6A1-4V, such as rods, screws, and bolts, indicating it is a hardware-based implantable system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "implantable device for the fixation of... femoral fractures." This describes a surgical implant used to treat a physical condition within the body.
- Device Description: The device description details components like "Femoral Intramedullary Rod System," "Transcorticle Interlocking Screws," "Locking Bolt," and "Recon Cancellous Screws." These are all components of a surgical implant used for bone fixation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
TRUE/FIT™ Femoral Intramedullary Rod System is intended as an implantable device for the fixation of the following types of femoral fractures:
- a. femoral shaft fractures
- b. high and low subtrochanteric fractures of the femur (femoral shaft fractures distal to the proximal portion of the lesser trocahanter)
- c. intertrochanteric femoral fractures
- d. femoral neck fractures
- e. ipsilateral femoral neck and shaft fractures
Product codes
CFR 888.3040.
Device Description
TRUE/FIT™ Femoral Intramedullary Rod System (Ti-6A1-4V) consists of:
-
- Distal Segment
- Transcorticle Interlocking Screws A.
- Proximal Segments 2.
- Standard Segment A.
- Dynamic Compression Segment B.
- Locking Bolt a.
- Dynamic Compression Bolt b.
- End Caps C.
- Transcorticle Interlocking Screws d.
- C. Recon/Oblique Segment
- Recon Cancellous Screws a.
- Oblique Screws b.
- Transcorticle Interlocking Screws c.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral, femur
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
MAR 1 3 1997
Summary of Safety and Effectiveness
Encore Orthopedics®, Inc. 8900 Shoal Creek Blvd. Ste 300 Austin, TX 78757 Ashley Bock
Trade Name: TRUE/FIT™ Femoral Intramedullary Rod System
Common Name: Femoral intramedullary rod and modular components
Classification Name: Smooth or threaded metallic bone fixation fastener CFR 888.3040.
Description: TRUE/FIT™ Femoral Intramedullary Rod System (Ti-6A1-4V) consists of:
-
- Distal Segment
- Transcorticle Interlocking Screws A.
- Proximal Segments 2.
- Standard Segment A.
- Dynamic Compression Segment B.
- Locking Bolt a.
- Dynamic Compression Bolt b.
- End Caps C.
- Transcorticle Interlocking Screws d.
- C. Recon/Oblique Segment
- Recon Cancellous Screws a.
- Oblique Screws b.
- Transcorticle Interlocking Screws c.
Intended Use:
TRUE/FIT™ Femoral Intramedullary Rod System is intended as an implantable device for the fixation of the following types of femoral fractures:
- a. femoral shaft fractures
- b. high and low subtrochanteric fractures of the femur (femoral shaft fractures distal to the proximal portion of the lesser trocahanter)
- c. intertrochanteric femoral fractures
- d. femoral neck fractures
- e. ipsilateral femoral neck and shaft fractures
1
Encore Orthopedics®, Inc. TRUE/FIT™ Femoral Intramedullary Rod System 512-206-1437 Ashley M. Bock Page 2
Comparable Features to Predicate Device(s):
| Product Name (Exhibit III) | Company | K Number |
|---|---|---|
| Gross/Kempf Femoral Nail | Howmedica | K813371 |
| Russell/Taylor Femoral Nail | Richards Medical | K893377 |
| Universal Nailing System | Synthes | K914371 |