Agility LP Total Ankle Prosthesis
510(k) K053569
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK053569 | Date31 Mar 2006 | 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- Withdrawn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
- HSN
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3110
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Agility LP Total Ankle Prosthesis is a semi-constrained, cemented ankle replacement designed for total ankle arthroplasty. It features a metal/polymer construction to restore mobility and weight-bearing function in patients with severe ankle arthritis or degenerative joint disease.
This device is intended for use in orthopedic surgical settings and is supplied as a reusable implant system. It requires cement fixation and is classified as a Class II medical device under FDA regulations. Multiple reference codes (e.g., 3010375065, 1000200989) correspond to specific implant configurations, and sterility is maintained through manufacturer-provided packaging. The device holds an FDA 510(k) clearance under Special Review (K053569).
Other devices from Depuy Orthopaedics, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of patients is the Agility LP Total Ankle Prosthesis designed to help, and how does it differ from other ankle replacements?
The Agility LP Total Ankle Prosthesis is specifically designed for patients suffering from severe ankle arthritis or degenerative joint disease who require total ankle arthroplasty. Unlike some ankle replacements, it is a semi-constrained, cemented implant made of metal and polymer, which helps restore mobility and weight-bearing function. Its semi-constrained design provides stability while allowing natural ankle movement, making it suitable for patients who need a balance between flexibility and support.
Is the Agility LP Total Ankle Prosthesis intended for single-use or can it be reused?
The Agility LP Total Ankle Prosthesis is supplied as a reusable implant system. It is intended for surgical use in orthopedic settings and is not designed for single-patient use. The device is meant to be implanted permanently in patients, and its construction and packaging maintain sterility for surgical use.
How many different configurations or sizes are available for the Agility LP Total Ankle Prosthesis, and how are they identified?
The Agility LP Total Ankle Prosthesis comes in multiple configurations, each identified by a unique FEI (Final Establishment Identifier) number. There are over 70 distinct configurations listed, such as 3010375065, 1000200989, and others, which correspond to specific implant sizes and designs. These variations allow surgeons to select the appropriate fit for each patient’s anatomy and clinical needs.
How is sterility maintained for the Agility LP Total Ankle Prosthesis, and what should be considered during storage?
Sterility for the Agility LP Total Ankle Prosthesis is maintained through manufacturer-provided packaging designed to preserve its sterile condition until use. It is critical to follow the manufacturer’s storage guidelines, including protecting the packaging from contamination, extreme temperatures, and moisture. The device should be stored in a clean, dry environment as directed by DePuy Orthopaedics to ensure it remains suitable for surgical use.
What regulatory pathway was followed for the FDA clearance of the Agility LP Total Ankle Prosthesis, and what does this mean for clinicians?
The Agility LP Total Ankle Prosthesis received FDA clearance through a 510(k) pathway with Special Review (K053569), classified as substantially equivalent to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared device, ensuring it meets safety and effectiveness standards. Clinicians can rely on this clearance as evidence of the device’s regulatory scrutiny and compliance with FDA requirements for orthopedic implants.