← Product Code [HSB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB) · K961360 # TRUE/FIT FEMORAL INTRAMEDULLARY ROD SYSTEM (K961360) _Encore Orthopedics, Inc. · HSB · Mar 13, 1997 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K961360 ## Device Facts - **Applicant:** Encore Orthopedics, Inc. - **Product Code:** [HSB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB.md) - **Decision Date:** Mar 13, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3020 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **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. ## Regulatory 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](/device/K813371.md)) - Russell/Taylor Femoral Nail ([K893377](/device/K893377.md)) - Universal Nailing System ([K914371](/device/K914371.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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 {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 | --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K961360](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSB/K961360) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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