(338 days)
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
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.
I'm sorry, but based on the provided text, I cannot answer your request. The document describes a medical device, its components, intended use, and a comparison to predicate devices, but it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as outlined in your prompt.
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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
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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 |
§ 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.