TRUE/FIT FEMORAL INTRAMEDULLARY ROD SYSTEM

K961360 · Encore Orthopedics, Inc. · HSB · Mar 13, 1997 · Orthopedic

Device Facts

• Record ID: K961360
• Device Name: TRUE/FIT FEMORAL INTRAMEDULLARY ROD SYSTEM
• Applicant: Encore Orthopedics, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Mar 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

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

Device Story

TRUE/FIT™ Femoral Intramedullary Rod System; modular metallic bone fixation device. Components: distal segment with transcortical interlocking screws; proximal segments including standard, dynamic compression, and recon/oblique options with associated bolts and screws. Material: Ti-6Al-4V. Used by orthopedic surgeons in clinical/OR settings for fracture stabilization. Provides mechanical fixation to facilitate bone healing. Output: physical structural support for fractured femur.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Ti-6Al-4V alloy. Design: Modular intramedullary rod system with distal/proximal segments, interlocking screws, locking/compression bolts, and end caps. Mechanical fixation principle. No software or electronic components.

Indications for Use

Indicated for patients requiring fixation of femoral shaft, high/low subtrochanteric, intertrochanteric, femoral neck, and ipsilateral femoral neck/shaft fractures.

Regulatory Classification

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.

Predicate Devices

• Gross/Kempf Femoral Nail (K813371)
• Russell/Taylor Femoral Nail (K893377)
• Universal Nailing System (K914371)

Submission Summary (Full Text)

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K961360

MAR 13 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-6Al-4V) consists of:

1. Distal Segment
A. Transcorticle Interlocking Screws

2. Proximal Segments
A. Standard Segment
B. Dynamic Compression Segment
a. Locking Bolt
b. Dynamic Compression Bolt
c. End Caps
d. Transcorticle Interlocking Screws
C. Recon/Oblique Segment
a. Recon Cancellous Screws
b. Oblique Screws
c. Transcorticle Interlocking Screws

**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 |