# K152966: Aequalis Fx2

- Pathway: 510(k) (Special)
- Applicant: Tornier S.A.S.
- Decided: Jan 14, 2016 after 99 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K911686 (1991). 104 ancestors in all.
No later device cites it as a predicate yet.
1 of 105 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141345: Aequalis FX2, Tornier S.A.S. (2014) Summary page 4.
- K030941: Aequalis Reversed Shoulder Prosthesis, Tornier (2004) Summary page 4.

## Recalls of this device
- Sep 19, 2016 · Class II · Z-0699-2017: Tornier is conducting a recall on Aequalis Fx2 ( implant parts and instrument trays) due to reports of dislocations of the poly insert and the stem.

## Indications for use
IN ANATOMIC: The Aequalis Fx2 humeral stem combined with the Flex Shoulder System humeral head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The Aequalis Fx2 is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain. The Aequalis Fx2 is indicated for use as a replacement of shoulder joints disabled by: - Rheumatoid arthritis with pain - Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) - Correction of functional deformity - Fractures of the proximal humerus except for size 50mm(1) - Traumatic arthritis - Revision of other devices if sufficient bone stock remains except for size 50mm(1) IN REVERSE: The Aequalis Fx2 is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by: - Rheumatoid arthritis - Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) - Correction of functional deformity - Fractures of the proximal humerus except for size S0mm(|1 - Traumatic arthritis - Revision of the devices if sufficient bone stock remains except for size S0mm(1)..The reversed insert is permitted to be used in the transformation from anatomic to reverse Aequalis Fx2 without the removal of the humeral stem, and if it is well fixed, during a revision surgery, for patient with a functional deltoid muscle. Notes: - all components are single use. - the humeral stem is for cemented use only, except for size 50mm which is for uncemented use only(1). - The all-poly glenoid components are intended for cemented use only. - the glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation - the humeral head diameters 37 and 39mm must be utilized only with the stem with a small metaphysis. The humeral head must cover completely the stem metaphysis . (1) The 50mm length of the Aequalis Fx2 stem is not available for sale within the United States.

Source page: https://510kreport.com/device/K152966
Methodology: https://510kreport.com/methodology