Aequalis Reversed Prosthesis
by Tornier
510(k) K061439
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK061439 | Date20 Jul 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- Withdrawn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
- PHX
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3660
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Aequalis Reversed Prosthesis is a shoulder arthroplasty device classified as a Reversed Shoulder Prosthesis under orthopedic nomenclature. It is designed to restore shoulder function in patients with massive, irreparable rotator cuff tears by reversing the natural anatomy of the joint, allowing the humeral component to articulate with the glenoid surface. This configuration facilitates medialization of the center of rotation within the glenoid bone and distalization of the humerus, which helps retension the deltoid muscle and any remaining competent rotator cuff tissues. The design aims to improve stability and restore active range of motion in compromised shoulder joints.
This device is supplied as a sterile, single-use implant intended for surgical use in orthopedic procedures. It is regulated under FDA 510(k) clearance (K061439) as substantially equivalent to a predicate device, with approval categorized under the Orthopedic (OR) advisory committee. The prosthesis is manufactured by Tornier and includes anatomical features such as a proximal body for tuberosity positioning and, in certain variants, a bone graft window with hydroxyapatite (HA) coating to support tuberosity healing. Storage and handling must comply with sterile surgical instrument protocols to ensure integrity prior to implantation.
Other devices from Tornier, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Aequalis Reversed Prosthesis designed to treat?
The Aequalis Reversed Prosthesis is specifically designed for patients with massive, irreparable rotator cuff tears. By reversing the natural shoulder anatomy, it allows the humeral component to articulate with the glenoid surface, medializing the joint’s center of rotation and distalizing the humerus. This configuration helps retension the deltoid muscle and any remaining competent rotator cuff tissues, improving stability and restoring active range of motion in compromised shoulder joints.
How is the Aequalis Reversed Prosthesis supplied and intended for use?
The prosthesis is supplied as a sterile, single-use implant. It is intended exclusively for surgical orthopedic procedures and must be handled according to sterile surgical instrument protocols to maintain its integrity before implantation. The design ensures it is not reusable, aligning with standard single-use orthopedic implant practices.
Does the Aequalis Reversed Prosthesis include features to support tuberosity healing?
Yes, certain variants of the Aequalis Reversed Prosthesis include a bone graft window with hydroxyapatite (HA) coating. This feature is specifically designed to facilitate tuberosity healing, promoting integration and stability during the postoperative recovery period.
What regulatory pathway does the Aequalis Reversed Prosthesis follow?
The device has obtained FDA 510(k) clearance under the classification of a Special clearance type, with a decision code of SESE (Substantially Equivalent Special). It was reviewed by the Orthopedic (OR) advisory committee and is categorized under product code PHX. The clearance (K061439) confirms its substantial equivalence to a predicate device.
How should the Aequalis Reversed Prosthesis be stored before use?
The prosthesis must be stored in compliance with sterile surgical instrument protocols to preserve its sterility and integrity. This includes maintaining appropriate environmental conditions, such as temperature and humidity controls, and ensuring the packaging remains uncompromised until the moment of surgical use.