Alta Femoral Intramedullary Rod System, Add Sizes

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K922266 ↗

FDA Product Code

HSB

Device Class

Class II

Regulation

21 CFR Part 888.3020

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Howmedica(R) Fully Threaded Screws

  Class II

  FDA 510(k) K974720 Active Cleared 13 Mar 1998

• Alta Femoral Intramedullary Rods/Cfx Rods Modification

  Class II

  FDA 510(k) K935295 Active Cleared 11 Oct 1994

• Naso-Gard Nasogastric Tube Holder

  Class II

  FDA 510(k) K801511 Active Cleared 28 Jul 1980

• Class of Casting Alloys Type III or Alt

  Class II

  FDA 510(k) K820434 Active Cleared 11 Mar 1982

• Howmedica Zirconia Ceramic Femoral Head

  Class II

  FDA 510(k) K945090 Active Cleared 19 Jan 1995

• Extended Balljoint Grip

  Class II

  FDA 510(k) K802723 Active Cleared 19 Nov 1980

See all devices from Howmedica Corp. →

• What is the Alta Femoral Intramedullary Rod System, Add Sizes used for?

  The device is designed for intramedullary nailing of femoral shaft fractures. It consists of curved, fluted titanium alloy rods, cross-locking screws, and cap screws that are inserted via antegrade or retrograde approach into the intramedullary canal to stabilize the fracture. This is its intended clinical use as described in the device specifications.

• How is the Alta Femoral Intramedullary Rod System supplied and is it reusable?

  The device is supplied by Howmedica Corp. as a sterile, single-use implant system. The rods, screws, and accessories are intended for one-time use only and must not be reprocessed or reused, as reusing could compromise structural integrity and increase infection risk. Sterility is maintained until the package is opened and the device is used in a sterile field.

• What materials and design features characterize the Alta Femoral Intramedullary Rod System?

  The system includes curved, fluted rods made of titanium alloy, which provide strength and flexibility while reducing stress shielding. It also includes cross-locking screws and cap screws for axial and rotational stability. The fluted design helps distribute load and allows for bone ingrowth, while the curvature matches the femoral anatomy for proper alignment during insertion.

• What regulatory pathway was used for the Alta Femoral Intramedullary Rod System, Add Sizes?

  The device received FDA 510(k) clearance under submission K922266 on September 21, 1992, through a traditional review process. It was determined to be substantially equivalent to a predicate device and is classified as Class II with special controls. The product code is HSB, and the review was conducted with input from the Orthopedic advisory committee.

• What sizes or configurations are available in the Alta Femoral Intramedullary Rod System, Add Sizes?

  The device is named 'Add Sizes,' indicating it includes additional rod lengths or diameters beyond the original Alta Femoral Rod System offerings. While specific dimensions are not listed in the provided data, the system is designed to accommodate a range of patient anatomies and fracture patterns through multiple rod sizes, allowing surgeons to select the appropriate fit based on femoral canal diameter and patient height.