# K253046: HERA Interlocking Intramedullary Nailing System

- Pathway: 510(k) (Traditional)
- Applicant: ZheJiang Decans Medical Devices Co., Ltd.
- Decided: Jun 16, 2026 after 267 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K951740 (1995). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172830: Double Medical Femoral Nail System, Double Medical Technology, Inc. (2018) Summary page 5.
- K040212: Trigen Intertan, Smith & Nephew, Inc. (2004) Summary page 5.
- K040462: Trigen Trochanteric Antegrade Nail, Smith & Nephew, Inc. (2004) Summary page 5.
- K131609: Double Engine Intrameddullary Nail System, Xiamen Double Engine Medical Material Co., Ltd. (2014) Summary page 6.

## Indications for use
(1)Femoral Trochanteric Fixation Nail System Femoral Trochanteric Fixation Nail System is intended use to: a)Pertrochanteric, intertrochanteric or Subtrochanteric fractures; b)Combination fractures of femur; c)Pathological fractures or reconstruction following tumor resection and grafting; d)Poor healing of fracture, including nonunions, malunions and bone lengthening or shortening; e)Other fracture, including simple severely comminuted, spiral, long oblique and segmental fractures of femur. (2)Antegrade Femoral Reconstruction Nail System Antegrade Femoral Reconstruction Nail System rencon mode is intended use to Femoral shaft and neck fracture ; standard mode is intended use to Femoral shaft fracture. (3)Tibial Nail system Tibial nail system is intended to be implanted into the medullary canal of tibia for alignment, stabilization, fixation of fractures caused by trauma or disease.

Source page: https://510kreport.com/device/K253046
Methodology: https://510kreport.com/methodology