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Flexible Humeral Nail System

by Synthes (Usa)

510(k) K972516

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK972516 Date4 Sep 1997ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Synthes (USA) Flexible Humeral Nail(Flex Nail) System
510(k) Number
FDA Product Code
JDS
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Flexible Humeral Nail System is a flexible, non-reamed, locking intramedullary fixation device classified as a bone fixation nail. It is designed to stabilize and align humeral shaft fractures by bridging the fracture site within the medullary canal, distributing weight-bearing loads, and promoting proper bone healing. Suitable for acute humeral shaft fractures, including transverse, oblique, butterfly, and segmental fractures of varying comminution grades, the system aids in maintaining alignment during the healing process.

This device is intended for orthopedic use in surgical settings and has received FDA 510(k) clearance under the traditional review pathway. Supplied as a reusable system, it is not intended for MRI use and must be handled according to sterile surgical protocols. The system includes multiple nail references (e.g., 3002806685, 1000306431) and is regulated under product code JDS for bone fixation nails. Storage and handling follow standard orthopedic surgical guidelines to ensure sterility and functionality.

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