Conquest Fn
by Smith & Nephew, Inc. 3 variants
510(k) K193029
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK193029 | Date28 Feb 2020 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JDO
- 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
The Conquest FN Femoral Neck Fracture System is a fixation device classified as a Proximal Femoral Implant. It is designed to stabilize femoral neck fractures through the use of contoured locking bone plates and compatible locking and non-locking screws, providing fixed-angle stability and post-operative compression to facilitate bone healing and preserve bone integrity.
This system is intended for orthopedic use in surgical settings and is supplied as a reusable medical device. It is manufactured from metallic materials and includes multiple plate sizes and screw configurations, as referenced by the listed FEI numbers. The device is regulated under FDA 510(k) clearance (K193029) and falls under the classification of Class II medical devices (regulation number 888.3030). Sterility and MRI safety are not specified in the provided data.
Other devices from Smith & Nephew, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Conquest FN Femoral Neck Fracture System used for?
The Conquest FN Femoral Neck Fracture System is designed to stabilize and fix femoral neck fractures. It achieves this through the use of contoured locking bone plates and compatible locking/non-locking screws, which provide fixed-angle stability and post-operative compression. This design helps facilitate bone healing while preserving bone integrity, making it ideal for orthopedic surgical applications involving femoral neck fractures.
How is the Conquest FN Femoral Neck Fracture System supplied?
The Conquest FN Femoral Neck Fracture System is supplied as a reusable medical device. It is manufactured from metallic materials and includes a variety of plate sizes and screw configurations, each referenced by specific FEI numbers. This modular design allows for customization to fit different clinical scenarios.
What materials is the Conquest FN Femoral Neck Fracture System made from?
The Conquest FN Femoral Neck Fracture System is manufactured from metallic materials. The specific alloys or compositions are not detailed in the provided data, but the use of metal ensures durability and structural integrity for orthopedic fixation purposes.
Does the Conquest FN Femoral Neck Fracture System come in different sizes or models?
Yes, the Conquest FN Femoral Neck Fracture System offers multiple plate sizes and screw configurations, each identified by unique FEI numbers. These variations allow surgeons to select the appropriate components for different patient anatomies and fracture patterns, ensuring a tailored fit and optimal fixation.
Is sterility or MRI safety information provided for the Conquest FN Femoral Neck Fracture System?
The provided data does not specify details regarding sterility or MRI safety for the Conquest FN Femoral Neck Fracture System. Clinicians should verify these aspects with the manufacturer or consult relevant guidelines before use, particularly if MRI imaging is anticipated post-surgery.