# K130048: Reverse Shoulder Prosthesis Monoblock

- Pathway: 510(k) (Traditional)
- Applicant: Encore Medical L.P.
- Decided: Oct 29, 2013 after 294 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: 9 generations back to K911686 (1991). 34 ancestors in all.
59 later devices descend from it; 3 cite it directly.
0 of 94 devices in its family (counting itself) have 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 5.
- K122692: Zimmer Trabecular Metal Reverse Shoulder System, Non-Porous Humeral Stems, Zimmer, Inc. (2012) Summary page 5.
- K111735: Reverse Shoulder Prosthesis Monoblock Hemi Adapter, Encore Medical L.P. (2011) Summary page 5.

## Most influential descendants
- K140904: RSP Monoblock Stem with P2 Coating, Size 6 (2014), 55 descendants of its own
- K162024: AltiVate Anatomic Shoulder System (2016), 34 descendants of its own
- K141006: RSP Humeral Socket Insert (2014), 21 descendants of its own
- K151293: Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis (2015), 20 descendants of its own
- K141990: Encore Humeral Shoulder Stem (2014), 19 descendants of its own

## Indications for use
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. Indications for RSP Humeral Stem Adapters: The Reverse® Shoulder Prosthesis (RSP) is indicated for treatment of 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 glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only. During primary surgery, after the humerus is prepared for the RSP humeral stem (modular and monoblock), if purchase to the glenoid bone is insufficient to bear the load of the glenoid baseplate and alternative glenoid bone reconstruction and/or repair is inadequate, the corresponding RSP humeral stem adapter can be used to convert the RSP humeral stem to hemiarthroplasty prosthesis as a salvage procedure. During revision surgery of an RSP (modular or monoblock), if the glenoid bone stock appears to be insufficient to bear the load of the glenoid baseplate and alternative glenoid bone reconstruction and/or repair is inadequate, the corresponding RSP humeral stem adapter can be used to convert the RSP device to hemiarthroplasty prosthesis as a salvage procedure. For modular RSP stems, the Foundation Shoulder humeral head should be used. For the monoblock stem, the Turon humeral head should be used. This stem/adapter construct is not approved for use as a surrogate for traditional hemiarthroplasty or anatomic replacement indications.

Source page: https://510kreport.com/device/K130048
Methodology: https://510kreport.com/methodology