# K141006: RSP Humeral Socket Insert

- Pathway: 510(k) (Special)
- Applicant: Djo Global
- Decided: Jun 5, 2014 after 48 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K911686 (1991). 89 ancestors in all.
21 later devices descend from it; 4 cite it directly.
0 of 111 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 6.
- K051075: Encore Reverse Shoulder Prosthesis, Encore Medical L.P. (2005) Summary page 6.
- K092873: Reverse Shoulder Prosthesis, Djo Surgical (2009) Summary page 6.
- K100741: Reverse Shoulder Prosthesis Monoblock Stem, Reverse Shoulder Prosthesis Humeral Inserts, Model 510-00-006/012, Encore Medical L.P. (2010) Summary page 6.
- K103208: Reverse Shoulder Prosthesis Monoblock Stem, Encore Medical L.P. (2011) Summary page 6.
- K130365: X-Alt Highly Cross Linked VE Acetabular Liner, Encore Medical L.P. (2013) Summary page 6.
- K130048: Reverse Shoulder Prosthesis Monoblock, Encore Medical L.P. (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
- Aug 7, 2020 · Class II · Z-3021-2020: Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the Surgeon implanting th
- Aug 7, 2020 · Class II · Z-3022-2020: Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the Surgeon implanting th

## Indications for use
The Reverse® Shoulder Prosthesis (RSP®) is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy, 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 glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only. 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 glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only. The Reverse® Shoulder Prosthesis Monoblock is indicated for patients with a functional deltoid muscle with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint: In cases of fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder, including humeral head fracture or displaced 3- or 4-part fractures of proximal humerus. (For cemented implantation only) In cases of bone defect in proximal humerus. The patient's joint must be anatomically and structurally suited to receive the selected implant(s). The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented or cementless use.

Source page: https://510kreport.com/device/K141006
Methodology: https://510kreport.com/methodology