510(k) · Cleared
ClearedSMR 3-Pegs Glenoids
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lima Corporate S.P.A. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Jun 12, 2013 as substantially equivalent to K100858 (Lima-Lto S.P.A., 2010) and 5 other predicates after a 93-day review. Its family tree reaches back 6 generations to 1991. 14 later devices descend from it.
- Decided
- Jun 12, 2013
- Review
- 93 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to K911686 (1991). 42 ancestors in all, the oldest K800494 (1980). 14 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 5 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 4 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 3 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 2 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 1 generation backK111212 SMR Shoulder System- Revision StemsLima Corporate S.P.A. · 2011
- This deviceK130642 SMR 3-Pegs GlenoidsLima Corporate S.P.A. · 2013
- Descendant · cites it directly · 13 of its ownK153722 SMR 3-Pegs GlenoidsLima Corporate S.P.A. · 2016
- Descendant · cites it directly · 12 of its ownK163397 SMR Hybrid Glenoid SystemLima Corporate S.P.A. · 2017 · Recalled
- Descendant · 2 generations on · 8 of its ownK190911 Physica KR Liner and SMR Reverse Humeral LinerLimacorporate · 2019
- Descendant · 3 generations on · 7 of its ownK220792 SMR Reverse LinerLima Corporate S.P.A. · 2022
- Descendant · 4 generations on · 3 of its ownK223876 SMR Shoulder SystemLima Corporate S.P.A. · 2023
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A. · 2016 · cites it directly13descendants
- K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A. · 2017 · cites it directly12descendants
- K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate · 2019 · 2 generations on8descendants
- K220792SMR Reverse LinerLima Corporate S.P.A. · 2022 · 3 generations on7descendants
- K223876SMR Shoulder SystemLima Corporate S.P.A. · 2023 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −5 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −4 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −3 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −2 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −1 | K111212 | SMR Shoulder System- Revision Stems | Lima Corporate S.P.A. | 2011 | — |
| 0 (this device) | K130642 | SMR 3-Pegs Glenoids | Lima Corporate S.P.A. | 2013 | — |
| +1 | K153722 | SMR 3-Pegs Glenoids | Lima Corporate S.P.A. | 2016 | — |
| +1 | K163397 | SMR Hybrid Glenoid System | Lima Corporate S.P.A. | 2017 | 1 |
| +2 | K190911 | Physica KR Liner and SMR Reverse Humeral Liner | Limacorporate | 2019 | — |
| +3 | K220792 | SMR Reverse Liner | Lima Corporate S.P.A. | 2022 | — |
| +4 | K223876 | SMR Shoulder System | Lima Corporate S.P.A. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 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? (6)
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 |
|---|---|---|---|
| * | K100858 | Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral…Summary page 3…the addition of screws for fixation. Predicate Devices: o Limacorporate SMR Cemented Glenoids included in the following cleared 510(k): - SMR Cemented Shoulder System (K100858); - SMR Uncemented Shoulder System (K101263); - SMR CTA Humeral Heads (K110847); - SMR Revision Stems (K111212). . Global Shoulde… | 2010 |
| * | K101263 | Lima-Lto SMR Shoulder System - Finned Humeral Stems, Lima-Lto SMR Shoulder System -…Summary page 3…cate Devices: o Limacorporate SMR Cemented Glenoids included in the following cleared 510(k): - SMR Cemented Shoulder System (K100858); - SMR Uncemented Shoulder System (K101263); - SMR CTA Humeral Heads (K110847); - SMR Revision Stems (K111212). . Global Shoulder Crosslink Glenoid (DePuy, K052472); . Glen… | 2011 |
| * | K110847 | SMR Shoulder System - Cta Humeral HeadsSummary page 3…emented Glenoids included in the following cleared 510(k): - SMR Cemented Shoulder System (K100858); - SMR Uncemented Shoulder System (K101263); - SMR CTA Humeral Heads (K110847); - SMR Revision Stems (K111212). . Global Shoulder Crosslink Glenoid (DePuy, K052472); . Glenoid Component for the Foundation To… | 2011 |
| * | K111212 | SMR Shoulder System- Revision StemsSummary page 3…following cleared 510(k): - SMR Cemented Shoulder System (K100858); - SMR Uncemented Shoulder System (K101263); - SMR CTA Humeral Heads (K110847); - SMR Revision Stems (K111212). . Global Shoulder Crosslink Glenoid (DePuy, K052472); . Glenoid Component for the Foundation Total Shoulder System (Encore - DJ… | 2011 |
| * | K052472 | Depuy Global Shoulder Crosslink GlenoidSummary page 3…tem (K100858); - SMR Uncemented Shoulder System (K101263); - SMR CTA Humeral Heads (K110847); - SMR Revision Stems (K111212). . Global Shoulder Crosslink Glenoid (DePuy, K052472); . Glenoid Component for the Foundation Total Shoulder System (Encore - DJO, K960906). Comparable Features to Predicate Device(… | 2005 |
| * | K960906 | Foundation Glenoid ComponentSummary page 3…10847); - SMR Revision Stems (K111212). . Global Shoulder Crosslink Glenoid (DePuy, K052472); . Glenoid Component for the Foundation Total Shoulder System (Encore - DJO, K960906). Comparable Features to Predicate Device(s): The intended use and indications for use for the Limacorporate SMR 3-Pegs Glenoid… | 1996 |
What descends from it? (14)
See all 142 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 4 companies; a new generation was cleared every 4.4 years on median.
- 11 of the 42 ancestors have a recall of any class.
- Of its descendants, K153722 (Lima Corporate S.P.A., 2016) has gone furthest, with 13 descendants of its own.
- 8 other devices also cite its predicate K100858.
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 SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to: » Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis: « Inflammatory degenerative joint disease such as rheumatoid arthritis; » Treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods; » Revision of a…
Read the full statement (377 words)
The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to:
» Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis:
« Inflammatory degenerative joint disease such as rheumatoid arthritis;
» Treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
» Revision of a failed primary implant;
o ' Cuff tear arthropathy (CTA Heads only).
The Large Resection Stems (not available in the US) are indicated for oncology applications.
The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient’s joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table.
In the Anatomic shoulder the humeral construct consists of the humeral stem, the humeral body, the adaptor taper and the humeral head. In the Reverse shoulder the humeral construct consists of the humeral stem, the reverse humeral body and the reverse liner. On the humeral side the fixation of the humeral stem determines if the construct is cemented or uncemented.
The Anatomic glenoid construct consists of an all polyethylene glenoid or a metal back assembled with a liner while the Reverse glenoid construct consists of the metal back, the connector and the glenosphere. On the glenoid side the fixation of the all-polyethylene glenoid or the metal back determines if the construct is cemented or uncemented.
In the US, the SMR Metal Backed Glenoid/Liner construct, used as part of the SMR Anatomic Shoulder Replacement, is intended for use with bone cement and should be used without bone screws.
Outside the US, the SMR Metal Backed Glenoid/Liner construct, used as part of the SMR Anatomic Shoulder Replacement, is intended for uncemented use with the addition of screws for fixation.
The SMR Metal Backed Glenoid/Connector/Glenosphere construct, used as part of the SMR Reverse Shoulder replacement, is intended for uncemented use with the addition of screws for fixation.
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/K130642 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130642: SMR 3-Pegs Glenoids.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130642
Report an extraction error
Are you the manufacturer?
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