# K111629: Turon RSP Socket Shell-Neutral Model 508-02-000, Turon RSP Socket Shell-Offset Model 508-02-001

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Sep 16, 2011 after 95 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: 1 generation back to K041066 (2005). 2 ancestors in all.
40 later devices descend from it; 2 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041066: Encore Reverse Shoulder Prosthesis, Encore Medical L.P. (2005) Summary page 3.
- K080402: Encore Shoulder Primary Humeral Stem, Model 500-00, Encore Shoulder Humeral Head, Model 520-38, Encore Medical L.P. (2008) Summary page 3.

## Most influential descendants
- K131559: Match Point System (TM), Surgicase Connect, Match Point System (TM) Guides (2013), 35 descendants of its own
- K143374: BLUEPRINT Patient Specific Instrumentation (2015), 31 descendants of its own
- K160555: BLUEPRINT Patient Specific Instrumentation (2016), 25 descendants of its own
- K162800: BLUEPRINT Patient Specific Instrumentation (2017), 23 descendants of its own
- K203315: BLUEPRINT™ Patient Specific Instrumentation (2021), 18 descendants of its own

## Indications for use
The Reverse Humeral Socket Shell is indicated for revision surgeries in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The socket shell is only indicated for use with a well fixed Turon Humeral Stem.

Source page: https://510kreport.com/device/K111629
Methodology: https://510kreport.com/methodology