# K141990: Encore Humeral Shoulder Stem

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Nov 7, 2014 after 108 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K911686 (1991). 115 ancestors in all.
19 later devices descend from it; 3 cite it directly.
1 of 135 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100741: Reverse Shoulder Prosthesis Monoblock Stem, Reverse Shoulder Prosthesis Humeral Inserts, Model 510-00-006/012, Encore Medical L.P. (2010) Summary page 6.
- K111735: Reverse Shoulder Prosthesis Monoblock Hemi Adapter, Encore Medical L.P. (2011) Summary page 6.
- K130048: Reverse Shoulder Prosthesis Monoblock, Encore Medical L.P. (2013) Summary page 6.
- K103208: Reverse Shoulder Prosthesis Monoblock Stem, Encore Medical L.P. (2011) Summary page 6.
- K140904: RSP Monoblock Stem with P2 Coating, Size 6, Encore Medical L.P. (2014) Summary page 6.
- K080402: Encore Shoulder Primary Humeral Stem, Model 500-00, Encore Shoulder Humeral Head, Model 520-38, Encore Medical L.P. (2008) Summary page 6.
- K950651: Total Shoulder Prosthesis, Encore Orthopedics, Inc. (1995) Summary page 6.
- K950594: Hemi-Shoulder Prosthesis, Encore Orthopedics, Inc. (1995) Summary page 6.
- K082120: Aequalis Reversed Fracture Shoulder Prothesis, Tornier (2008) Summary page 6.
- K122698: Aequalis Ascend Flex Shoulder System, Tornier S.A.S. (2013) Summary page 6.

## Most influential descendants
- K172351: AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert (2017), 18 descendants of its own
- K190290: AltiVate Reverse Humeral Stem, 48mm (2019), 15 descendants of its own
- K202611: Catalyst OrthoScience R1 Reverse Shoulder System (2021), 5 descendants of its own
- K211991: Catalyst R1 Reverse Shoulder System (2021), 3 descendants of its own
- K213349: Catalyst R1 Reverse Shoulder System (2022), 2 descendants of its own

## Recalls of this device
- Jan 30, 2018 · Class II · Z-1241-2018: Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial.
- Dec 8, 2015 · Class II · Z-0626-2016: The trial shell mating feature on the broach is undersized.
- Sep 15, 2015 · Class II · Z-0131-2016: Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw.

## Indications for use
Anatomic Total Shoulder Indications: The Encore® Shoulder Prosthesis Stem is indicated as an Anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to: Noninflammatory degenerative joint disease including osteoarthritis; Inflammatory arthritis of the glenohumeral join including rheumatoid arthritis; Post-traumatic arthritis of the glenohumeral joint; Avascular necrosis of the humeral head with and without involvement of the glenoid; Correction of functional deformity The all-poly glenoid is intended for cemented use Hemi Shoulder Indications: The Encore® Shoulder Prosthesis Stem is indicated as a hemi shoulder joint replacement for patients suffering from pain and dysfunction due to: Noninflammatory degenerative joint disease including osteoarthritis; Inflammatory arthritis of the glenohumeral joint including rheumatoid arthritis; Post-traumatic arthritis of the glenohumeral joint; Avascular necrosis of the humeral head with and without involvement of the glenoid; Correction of functional deformity; Rotator cuff tear arthropathy; Humeral fracture. Failed previous shoulder surgery Reverse Total Shoulder Indications: The Encore® Shoulder Prosthesis Stem is as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to: Severe arthropathy with a grossly deficient rotator cuff; Previously failed joint replacement with a grossly deficient rotator cuff; Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection; Bone defect in proximal humerus; Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid; Inflammatory arthritis including rheumatoid arthritis; Correction of functional deformity. The glenoid baseplate is intended for cementless application with addition of screws for fixation. This device may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi procedures All humeral stems are intended for cemented or cementless use.

Source page: https://510kreport.com/device/K141990
Methodology: https://510kreport.com/methodology