510(k) · Cleared
Recalled · Class II · 2015Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral Bodies,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lima-Lto S.P.A. · KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Cleared on Dec 10, 2010 as substantially equivalent to K063578 (Plus Orthopedics AG, 2007) and 2 other predicates after a 259-day review. Its family tree reaches back 3 generations to 1987. 37 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 10, 2010
- Review
- 259 days
- Class
- Class II
- Product code
- KWT
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 3 generations to K873073 (1987). 15 ancestors in all. 37 later devices descend from it, 9 citing it directly.
- Root · 3 generations backK873073 Kirschner Neer-Iii Proximal HumerusKirschner Medical Corp. · 1987
- 2 generations backK961260 Kirschner Sholders with Titanium Plasma SprayBiomet, Inc. · 1997
- 1 generation backK992525 Acumed Modular Shoulder SystemAcu Med, Inc. · 2000 · Recalled
- This deviceK100858 Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder…Lima-Lto S.P.A. · 2010
- Descendant · cites it directly · 34 of its ownK110847 SMR Shoulder System - Cta Humeral HeadsLima Corporate S.P.A. · 2011
- Descendant · cites it directly · 33 of its ownK111212 SMR Shoulder System- Revision StemsLima Corporate S.P.A. · 2011
- Descendant · cites it directly · 31 of its ownK113254 SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular…Lima Corporate S.P.A. · 2012
- Descendant · 2 generations on · 20 of its ownK133349 SMR TT Metal Back GlenoidLima Corporate S.P.A. · 2014
- Descendant · cites it directly · 14 of its ownK130642 SMR 3-Pegs GlenoidsLima Corporate S.P.A. · 2013
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K110847SMR Shoulder System - Cta Humeral HeadsLima Corporate S.P.A. · 2011 · cites it directly34descendants
- K111212SMR Shoulder System- Revision StemsLima Corporate S.P.A. · 2011 · cites it directly33descendants
- K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsLima Corporate S.P.A. · 2012 · cites it directly31descendants
- K133349SMR TT Metal Back GlenoidLima Corporate S.P.A. · 2014 · 2 generations on20descendants
- K130642SMR 3-Pegs GlenoidsLima Corporate S.P.A. · 2013 · cites it directly14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K873073 | Kirschner Neer-Iii Proximal Humerus | Kirschner Medical Corp. | 1987 | — |
| −2 | K961260 | Kirschner Sholders with Titanium Plasma Spray | Biomet, Inc. | 1997 | — |
| −1 | K992525 | Acumed Modular Shoulder System | Acu Med, Inc. | 2000 | 1 |
| 0 (this device) | K100858 | Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System -… | Lima-Lto S.P.A. | 2010 | — |
| +1 | K110847 | SMR Shoulder System - Cta Humeral Heads | Lima Corporate S.P.A. | 2011 | — |
| +1 | K111212 | SMR Shoulder System- Revision Stems | Lima Corporate S.P.A. | 2011 | — |
| +1 | K113254 | SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular… | Lima Corporate S.P.A. | 2012 | — |
| +2 | K133349 | SMR TT Metal Back Glenoid | Lima Corporate S.P.A. | 2014 | — |
| +1 | K130642 | SMR 3-Pegs Glenoids | Lima Corporate S.P.A. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 5 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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 KWT? 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 KWT device
- #1 K231657 AGILON® XO Shoulder Replacement Systemscore 17.7 · 17 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 |
|---|---|---|---|
| * | K063578 | Promos Modular Shoulder SystemSummary page 2…actures of the humeral head that cannot be treated with other fracture fixation methods Predicate Devices: * Promos modular shoulder system (PlusOrthopedics, K063578) * Anatomical shoulder system (Centerpulse, K030259) * Modular shoulder system (Acumed, K992525) Comparable Features to Pr… | 2007 |
| * | K030259 | Amatomical Shoulder with Removable HeadSummary page 2…other fracture fixation methods Predicate Devices: * Promos modular shoulder system (PlusOrthopedics, K063578) * Anatomical shoulder system (Centerpulse, K030259) * Modular shoulder system (Acumed, K992525) Comparable Features to Predicate Device(s): The SMR Shoulder System is similar… | 2003 |
| * | K992525 | Acumed Modular Shoulder SystemSummary page 2…ate Devices: * Promos modular shoulder system (PlusOrthopedics, K063578) * Anatomical shoulder system (Centerpulse, K030259) * Modular shoulder system (Acumed, K992525) Comparable Features to Predicate Device(s): The SMR Shoulder System is similar to the predicate devices in terms of intended u… | 2000 |
What descends from it? (37)
See all 379 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110847 | SMR Shoulder System - Cta Humeral Heads | 2011 | 34 |
| K111212 | SMR Shoulder System- Revision Stems | 2011 | 33 |
| K113254 | SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone Screws | 2012 | 31 |
| K130642 | SMR 3-Pegs Glenoids | 2013 | 14 |
| K153722 | SMR 3-Pegs Glenoids | 2016 | 13 |
| K200368 | LINK Embrace Shoulder System - Reverse Configuration | 2021 | 3 |
| K161476 | SMR Shoulder System | 2016 | 1 |
| K212992 | LINK® Embrace Shoulder System - Reverse Configuration | 2021 | 0 |
| K183042 | SMR Lateralized Connectors with screws | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 14, 2015 | Class II | Z-2539-2015 | Nonconforming Material/Component | The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble. |
| Aug 14, 2015 | Class II | Z-2540-2015 | Nonconforming Material/Component | The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 9.5 years on median.
- 5 of the 15 ancestors have a recall of any class.
- Of its descendants, K110847 (Lima Corporate S.P.A., 2011) has gone furthest, with 34 descendants of its own.
- 5 other devices also cite its predicate K063578.
How does its category compare?
All KWT devicesKWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · KWT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWT
242in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWT
749in 2025
MAUDE reports naming product code KWT, 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 | 1 | — | 0 | 32 |
| 2008 | 0 | — | 1 | 48 |
| 2009 | 0 | — | 0 | 58 |
| 2010 | 1 | — | 7 | 71 |
| 2011 | 5 | 165 | 0 | 112 |
| 2012 | 1 | — | 2 | 83 |
| 2013 | 1 | — | 1 | 113 |
| 2014 | 1 | — | 0 | 168 |
| 2015 | 2 | — | 0 | 176 |
| 2016 | 2 | — | 1 | 445 |
| 2017 | 1 | — | 1 | 560 |
| 2018 | 2 | — | 1 | 480 |
| 2019 | 4 | 91 | 3 | 419 |
| 2020 | 1 | — | 0 | 215 |
| 2021 | 1 | — | 0 | 228 |
| 2022 | 1 | — | 0 | 273 |
| 2023 | 1 | — | 1 | 361 |
| 2024 | 1 | — | 0 | 601 |
| 2025 | 4 | 242 | 0 | 749 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The SMR Shoulder system is intended for partial or total primary shoulder joint replacement. The components are intended for use in cemented applications.
Total or hemi-shoulder replacement is indicated for 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100858 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100858: Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral Bodies,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100858
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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