# K080402: Encore Shoulder Primary Humeral Stem, Model 500-00, Encore Shoulder Humeral Head, Model 520-38

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Mar 28, 2008 after 43 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
78 later devices descend from it; 7 cite it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bio-Modular Choice Shoulder System: named in the summary without a submission number
- (no number) Global Advantage: named in the summary without a submission number

## Most influential descendants
- K111629: Turon RSP Socket Shell-Neutral Model 508-02-000, Turon RSP Socket Shell-Offset Model 508-02-001 (2011), 40 descendants of its own
- K131559: Match Point System (TM), Surgicase Connect, Match Point System (TM) Guides (2013), 35 descendants of its own
- K123982: Turon Glenoid Pegged, E+, Turon Keeled Glenoid, E+ (2013), 35 descendants of its own
- K162024: AltiVate Anatomic Shoulder System (2016), 34 descendants of its own
- K143374: BLUEPRINT Patient Specific Instrumentation (2015), 31 descendants of its own

## Recalls of this device
- Nov 5, 2010 · Not classified · Z-0799-2011: Complaints of fracturing were reported for affected trial products.
- Nov 5, 2010 · Not classified · Z-0800-2011: Complaints of fracturing were reported for affected trial products.
- Nov 5, 2010 · Not classified · Z-0801-2011: Complaints of fracturing were reported for affected trial products.
- Nov 5, 2010 · Not classified · Z-0798-2011: Complaints of fracturing were reported for trial products.

## 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 natural 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. The glenoid components are indicated for cemented use only.

Source page: https://510kreport.com/device/K080402
Methodology: https://510kreport.com/methodology