Forceps, Ankle Inserting, Con-Axial
by Depuy, Inc. 510(k)
Active
510(k) K770420
Overview
This device is a forceps designed for ankle insertion with a con-axial configuration. It is classified as a prosthesis, ankle, semi-constrained, cemented, metal/polymer under FDA device classification.
The device received traditional 510(k) clearance (K770420) on March 14, 1977, and is substantially equivalent to a predicate device. It is manufactured by Depuy, Inc. and falls under the orthopedic medical specialty and advisory committee classification.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK770420 | Date14 Mar 1977 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HSN
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3110
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Depuy, Inc.
Questions
What is the Forceps Ankle Inserting Con-Axial used for?
This device is a forceps designed for ankle insertion with a con-axial configuration. It is used in orthopedic procedures to assist in the placement of ankle prostheses, specifically those classified as semi-constrained, cemented, metal/polymer devices.
How is the Forceps Ankle Inserting Con-Axial supplied and is it reusable?
The device data does not specify whether the forceps is supplied sterile or non-sterile, or whether it is intended for single-use or reuse. As a surgical instrument, it may be designed for reuse after proper cleaning and sterilization, but this must be confirmed from the manufacturer's labeling.
What sizes or models are available for the Forceps Ankle Inserting Con-Axial?
The device data does not list specific sizes, models, or reference numbers for the Forceps Ankle Inserting Con-Axial. The identifier 'FORCEPS, ANKLE INSERTING, CON-AXIAL' is the device name, and no additional model or size variations are provided in the available information.
What are the storage requirements for the Forceps Ankle Inserting Con-Axial?
The device data does not include any storage conditions or requirements for the Forceps Ankle Inserting Con-Axial. Storage instructions would typically be provided in the manufacturer’s labeling and should be followed to maintain device integrity and function.
What regulatory pathway was used for the Forceps Ankle Inserting Con-Axial?
The device received traditional 510(k) clearance (K770420) on March 14, 1977, and was determined to be substantially equivalent to a predicate device. This indicates it followed the FDA’s traditional 510(k) premarket notification process.