510(k) · Cleared
ClearedReverse Shoulder Prosthesis Monoblock
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Encore Medical L.P. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Oct 29, 2013 as substantially equivalent to K100741 (Encore Medical L.P., 2010) and 2 other predicates after a 294-day review. Its family tree reaches back 9 generations to 1991. 59 later devices descend from it.
- Decided
- Oct 29, 2013
- Review
- 294 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K911686 (1991). 34 ancestors in all, the oldest K790987 (1979). 59 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 5 generations between
- 3 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 2 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 1 generation backK122692 Zimmer Trabecular Metal Reverse Shoulder System, Non-Porous Humeral…Zimmer, Inc. · 2012
- This deviceK130048 Reverse Shoulder Prosthesis MonoblockEncore Medical L.P. · 2013
- Descendant · cites it directly · 55 of its ownK140904 RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P. · 2014
- Descendant · 2 generations on · 34 of its ownK162024 AltiVate Anatomic Shoulder SystemEncore Medical L.P. · 2016 · Recalled
- Descendant · cites it directly · 21 of its ownK141006 RSP Humeral Socket InsertDjo Global · 2014 · Recalled
- Descendant · 2 generations on · 20 of its ownK151293 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder…Tornier S.A.S. · 2015
- Descendant · cites it directly · 19 of its ownK141990 Encore Humeral Shoulder StemEncore Medical L.P. · 2014 · Recalled
Show all 9 generations
- Root · 9 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 8 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 7 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 6 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 5 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 4 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 3 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 2 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 1 generation backK122692 Zimmer Trabecular Metal Reverse Shoulder System, Non-Porous Humeral…Zimmer, Inc. · 2012
- This deviceK130048 Reverse Shoulder Prosthesis MonoblockEncore Medical L.P. · 2013
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P. · 2014 · cites it directly55descendants
- K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P. · 2016 · 2 generations on34descendants
- K141006RSP Humeral Socket InsertDjo Global · 2014 · cites it directly21descendants
- K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S. · 2015 · 2 generations on20descendants
- K141990Encore Humeral Shoulder StemEncore Medical L.P. · 2014 · cites it directly19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −8 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −7 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −6 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −5 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −4 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −3 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −2 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −1 | K122692 | Zimmer Trabecular Metal Reverse Shoulder System, Non-Porous Humeral Stems | Zimmer, Inc. | 2012 | — |
| 0 (this device) | K130048 | Reverse Shoulder Prosthesis Monoblock | Encore Medical L.P. | 2013 | — |
| +1 | K140904 | RSP Monoblock Stem with P2 Coating, Size 6 | Encore Medical L.P. | 2014 | — |
| +2 | K162024 | AltiVate Anatomic Shoulder System | Encore Medical L.P. | 2016 | 6 |
| +1 | K141006 | RSP Humeral Socket Insert | Djo Global | 2014 | 2 |
| +2 | K151293 | Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis | Tornier S.A.S. | 2015 | — |
| +1 | K141990 | Encore Humeral Shoulder Stem | Encore Medical L.P. | 2014 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 5 | 0 |
| 2021 | 6 | 0 |
| 2022 | 9 | 0 |
| 2023 | 6 | 0 |
| 2024 | 6 | 0 |
| 2025 | 7 | 0 |
| 2026 | 9 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KWS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KWS device
- #1 K220847 AETOS Shoulder Systemscore 21.1 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K100741 | Reverse Shoulder Prosthesis Monoblock Stem, Reverse Shoulder Prosthesis Humeral Inserts…Summary page 5…s not approved for use as a surrogate for traditional hemiarthroplasty or anatomic replacement indications. Predicate Devices: RSP Monoblock Humeral Stem, DJO Surgical, K100741 Zimmer Tribecular Metal Reverse Shoulder System, K122692 RSP Monoblock Hemi Adapter, K111735 Comparable Features to Predicate De… | 2010 |
| * | K122692 | Zimmer Trabecular Metal Reverse Shoulder System, Non-Porous Humeral StemsSummary page 5…iarthroplasty or anatomic replacement indications. Predicate Devices: RSP Monoblock Humeral Stem, DJO Surgical, K100741 Zimmer Tribecular Metal Reverse Shoulder System, K122692 RSP Monoblock Hemi Adapter, K111735 Comparable Features to Predicate Device(s): Features comparable to predicate devices include… | 2012 |
| * | K111735 | Reverse Shoulder Prosthesis Monoblock Hemi AdapterSummary page 5…t indications. Predicate Devices: RSP Monoblock Humeral Stem, DJO Surgical, K100741 Zimmer Tribecular Metal Reverse Shoulder System, K122692 RSP Monoblock Hemi Adapter, K111735 Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same material, indications, sur… | 2011 |
What descends from it? (59)
See all 593 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 10 of the 34 ancestors have a recall of any class.
- Of its descendants, K140904 (Encore Medical L.P., 2014) has gone furthest, with 55 descendants of its own.
- 6 other devices also cite its predicate K100741.
How does its category compare?
All KWS devicesKWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · KWS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWS
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWS
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWS
2,281in 2025
MAUDE reports naming product code KWS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 21 | 158 |
| 2008 | 4 | 37 | 29 | 238 |
| 2009 | 4 | 108 | 0 | 294 |
| 2010 | 7 | 33 | 10 | 393 |
| 2011 | 11 | 90 | 11 | 486 |
| 2012 | 7 | 86 | 10 | 542 |
| 2013 | 12 | 120 | 0 | 818 |
| 2014 | 7 | 89 | 1 | 1,066 |
| 2015 | 8 | 129 | 0 | 1,170 |
| 2016 | 10 | 114 | 1 | 970 |
| 2017 | 7 | 120 | 4 | 1,681 |
| 2018 | 4 | 152 | 1 | 1,545 |
| 2019 | 9 | 106 | 2 | 1,728 |
| 2020 | 3 | 98 | 5 | 1,567 |
| 2021 | 5 | 151 | 0 | 1,358 |
| 2022 | 5 | 158 | 0 | 1,268 |
| 2023 | 4 | 250 | 2 | 1,750 |
| 2024 | 2 | — | 0 | 2,122 |
| 2025 | 3 | 97 | 0 | 2,281 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
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…
Read the full statement (369 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130048 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130048: Reverse Shoulder Prosthesis Monoblock.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130048
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026