# K071948: Aequalis Reversed Adapter

- Pathway: 510(k) (Traditional)
- Applicant: Tornier
- Decided: Oct 18, 2007 after 97 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K911686 (1991). 32 ancestors in all.
178 later devices descend from it; 3 cite it directly.
0 of 211 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053274: Anatomical Shoulder Inverse/Reverse, Zimmer GmbH (2006) Summary page 4.
- K061439: Aequalis Reversed Prosthesis, Tornier (2006) Summary page 4.
- K050316: Aequalis Reversed Shoulder Prosthesis, Tornier (2005) Summary page 4.
- K041873: Aequalis Reversed Shoulder Prosthesis, Tornier (2004) Summary page 4.
- K030941: Aequalis Reversed Shoulder Prosthesis, Tornier (2004) Summary page 4.

## Most influential descendants
- K082120: Aequalis Reversed Fracture Shoulder Prothesis (2008), 164 descendants of its own
- K100142: Aequalis Reversed Shoulder Prosthesis (2010), 147 descendants of its own
- K110599: Aequalis Ascend Modular Reverse Shoulder System (2011), 108 descendants of its own
- K112615: Aequalis Ascend Modular Reverse Shoulder System (2011), 97 descendants of its own
- K122698: Aequalis Ascend Flex Shoulder System (2013), 96 descendants of its own

## Indications for use
The Aequalis Reversed Adapter is indicated for use as a component of a total shoulder replacement and is designed to allow the transformation of Aequalis Anatomical (monobloc or press-fit) or Aequalis Fracture stems into components of a reverse shoulder prosthesis without removal during revision surgery. The Aequalis Reversed Adapter is for use only when the implanted humeral stem is well fixed along its entire length and when the patient has a functional deltoid muscle and when the arthropathy is associated with a massive and non repairable rotator cuff-tear. The Aequalis Reversed Adapter is intended for uncemented use only. The Aequalis Reversed Adapter is intended to be used with the Aequalis Reversed glenoid which is anchored to the bone with 4 screws and which is for uncemented fixation. The Aequalis Reversed Adapter is intended to be used with a cemented (Aequalis monobloc or Aequalis Fracture) or uncemented (Aequalis press-fit) stem. The humeral component is not to be revised in the conversion to a reverse shoulder prosthesis and must be well fixed along its entire length.

Source page: https://510kreport.com/device/K071948
Methodology: https://510kreport.com/methodology