# K123982: Turon Glenoid Pegged, E+, Turon Keeled Glenoid, E+

- Pathway: 510(k) (Special)
- Applicant: Encore Medical L.P.
- Decided: Jan 23, 2013 after 28 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- 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: 7 generations back to K810258 (1981). 26 ancestors in all.
35 later devices descend from it; 1 cites it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080402: Encore Shoulder Primary Humeral Stem, Model 500-00, Encore Shoulder Humeral Head, Model 520-38, Encore Medical L.P. (2008) Summary page 1.
- K091956: Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712, Encore Medical L.P. (2010) Summary page 1.

## Most influential descendants
- K162024: AltiVate Anatomic Shoulder System (2016), 34 descendants of its own
- K190290: AltiVate Reverse Humeral Stem, 48mm (2019), 15 descendants of its own
- K202716: Ignite Anatomic Shoulder System (2021), 13 descendants of its own
- K212737: INHANCE™ Reverse Shoulder System (2022), 9 descendants of its own
- K202611: Catalyst OrthoScience R1 Reverse Shoulder System (2021), 5 descendants of its own

## Indications for use
Joint replacement is indicated for patients suffering from disability due to: • noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the humeral head and/or glenoid; • rheumatoid arthritis; • correction of functional deformity; • humeral fracture. This device may also be indicated in the salvage of previously failed surgical attempts. This system is to be used for cemented applications

Source page: https://510kreport.com/device/K123982
Methodology: https://510kreport.com/methodology