Arthrex Bayonet Knife
510(k) K925457
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK925457 | Date4 Mar 1993 | 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- Withdrawn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
- HRX
- Device class
- Class II
- Regulation
- 21 CFR Part 888.1100
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Arthrex Bayonet Knife is a hand-held manual surgical instrument classified as a surgical knife under product code HRX. It is designed for internal suturing procedures, such as advancing extracorporeally created suture knots to achieve appropriate tension in delicate surgical sites, including the thoracic cavity. The device features a long, thin, rod-like structure with a guiding mechanism, such as an eyelet, to facilitate precise knot placement during arthroscopic or minimally invasive surgeries.
This device is intended for single-use and is supplied sterile. It is regulated under FDA 510(k) clearance (K925457) and falls under the Orthopedic advisory committee review. The instrument is manufactured by Arthrex, Inc., and is intended for use in sterile surgical environments. No additional regulatory markings or MRI safety classifications are specified in the available data.
Other devices from Arthrex, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Arthrex Bayonet Knife used for?
The Arthrex Bayonet Knife is designed specifically for internal suturing procedures, particularly to advance extracorporeally created suture knots during arthroscopic or minimally invasive surgeries. Its long, thin rod and guiding eyelet allow surgeons to achieve precise knot placement and appropriate tension in delicate surgical sites, such as the thoracic cavity, without direct visual access.
How is the Arthrex Bayonet Knife supplied and prepared for use?
The device is supplied sterile and intended for single-use only. It must be used in sterile surgical environments, as required for all surgical instruments. No additional preparation beyond standard sterile field protocols is specified, ensuring it is ready for immediate use once opened.
Is the Arthrex Bayonet Knife reusable or disposable?
The Arthrex Bayonet Knife is explicitly designed for single-use only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility, precision, or safety during surgical procedures. Adherence to single-use guidelines ensures optimal performance and compliance with regulatory standards.
What distinguishes the Arthrex Bayonet Knife from other surgical knives?
Unlike traditional surgical knives, the Arthrex Bayonet Knife features a long, thin rod-like structure with an integrated guiding eyelet. This design enables surgeons to manipulate and advance suture knots internally during minimally invasive procedures, such as arthroscopy, where direct visualization is limited. Its specialized form facilitates precise knot placement in delicate areas like the thoracic cavity.
How should the Arthrex Bayonet Knife be stored before use?
The device should be stored in its original, sealed packaging until ready for use to maintain sterility. Storage conditions should comply with standard surgical instrument protocols, protecting it from contamination, moisture, or physical damage. Avoid exposure to extreme temperatures or direct sunlight, as these could degrade the instrument’s integrity or performance.