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Titanium Pediatric Femoral Nail

FDA 510(k)

Class II (US FDA 510(k))

510(k) K993956

by Biomet, Inc.

Identifiers

510(k) Number
K993956 FDA 510(k)
FDA Product Code
HSB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3020 FDA 510(k)
Regulation Number
888.3020 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Titanium Pediatric Femoral Nail is an intramedullary fixation device designed for pediatric femoral fractures. It is a rod-shaped implant inserted into the medullary canal of the femur to restore alignment and stabilize bone fragments during the healing process. The device features screw holes at both ends to allow for optional transverse screw fixation, enhancing stability where required. Classified as a Class II medical device under FDA regulations, it is intended for use in orthopedic surgical procedures.

This device is supplied sterile and intended for single-use in clinical settings, including operating rooms and trauma centers. It is manufactured from titanium, ensuring biocompatibility and durability. The nail is available in pediatric-specific sizes to accommodate the anatomical dimensions of children’s femurs. Storage requires adherence to sterile packaging protocols, and its use is governed by FDA clearance under 510(k) number K993956, with regulatory classification under product code HSB and advisory committee review by the Orthopedic Panel.

Frequently asked questions

What is the Titanium Pediatric Femoral Nail used for?

The Titanium Pediatric Femoral Nail is designed specifically for intramedullary fixation of pediatric femoral fractures. It is inserted into the medullary canal of the femur to restore proper bone alignment and stabilize fragments during the healing process. Its pediatric-specific design ensures compatibility with children’s anatomical dimensions, making it suitable for orthopedic surgical procedures in this age group.

How is the Titanium Pediatric Femoral Nail supplied and prepared for use?

The device is supplied sterile and intended exclusively for single-use in clinical settings like operating rooms or trauma centers. It comes in sterile packaging, so no additional sterilization is required before use. Always follow sterile packaging protocols to maintain integrity until implantation.

Is the nail reusable, or is it meant for one-time use?

This nail is explicitly designed for single-use only. Its sterile packaging and classification as a Class II medical device under FDA regulations indicate it is not intended for reuse. Reusing medical devices can compromise sterility and patient safety, so adherence to single-use guidelines is critical.

What sizes are available for the Titanium Pediatric Femoral Nail?

The nail is available in pediatric-specific sizes tailored to accommodate the anatomical dimensions of children’s femurs. Exact sizing details are included in the product documentation, ensuring proper fit and function for different age groups and fracture types. Always verify the correct size before use.

How should the Titanium Pediatric Femoral Nail be stored?

Storage must adhere to sterile packaging protocols to preserve the device’s sterility. Keep the nail in its original, unopened packaging until ready for use. Avoid exposure to moisture, extreme temperatures, or contamination, as these can compromise the integrity of the sterile barrier and the device itself.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: TITANIUM PEDIATRIC FEMORAL NAIL (K993956) — FDA 510 (k) | Innolitics, fda.innolitics.com, Titanium Pediatric Femoral Nail - Beudamed

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biomet, Inc.

Sources (1)

  • FDA 510(k) K993956 24 fields · synced Oct 1, 2026