510(k) · Cleared
ClearedSMR Stemless Anatomic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lima Corporate S.P.A. · PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Cleared on Mar 17, 2023 as substantially equivalent to K183194 (Arthrex, Inc., 2019) after a 274-day review. Its family tree reaches back 8 generations to 1991.
- Decided
- Mar 17, 2023
- Review
- 274 days
- Class
- Class II
- Product code
- PKC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K911686 (1991). 25 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet.
- Root · 8 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 7 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 6 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 5 generations backK060988 Total and Hemi Shoulder SystemDvo Extremity Solutions, LLC · 2006 · Recalled
- 4 generations backK103007 Affiniti Total and Hemi-Shoulder SystemTornier, Inc. · 2010
- 3 generations backK143552 Simpliciti Shoulder SystemTornier, Inc. · 2015
- 2 generations backK171858 Sidus Stem-Free ShoulderZimmer GmbH · 2017 · Recalled
- 1 generation backK183194 Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc. · 2019
- This deviceK221758 SMR Stemless AnatomicLima Corporate S.P.A. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −7 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −6 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −5 | K060988 | Total and Hemi Shoulder System | Dvo Extremity Solutions, LLC | 2006 | 13 |
| −4 | K103007 | Affiniti Total and Hemi-Shoulder System | Tornier, Inc. | 2010 | — |
| −3 | K143552 | Simpliciti Shoulder System | Tornier, Inc. | 2015 | — |
| −2 | K171858 | Sidus Stem-Free Shoulder | Zimmer GmbH | 2017 | 3 |
| −1 | K183194 | Arthrex Eclipse Shoulder Prosthesis System | Arthrex, Inc. | 2019 | — |
| 0 (this device) | K221758 | SMR Stemless Anatomic | Lima Corporate S.P.A. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2007 | 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 PKC? 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 PKC device
- #1 K240716 AETOS Shoulder System Stemless Humeral…score 22.2 · 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? (1)
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 |
|---|---|---|---|
| * | K183194 | Arthrex Eclipse Shoulder Prosthesis SystemSummary page 4…ation: 21 CFR 888.3660 Class: II Product Codes: PKC Primary Predicate Device: Arthrex Eclipse Shoulder Prosthesis Anatomic (K183194) Reference Devices: LimaCorporate S.p.A. SMR Shoulder System (K100858, K110598, K110847, K113… | 2019 |
| † | K100858 | Lima-Lio SMR Shoulder System - Humeral Stems, Lima-Lio SMR Shoulder System - Humeral… | 2010 |
| † | K110598 | SMR Reverse Shoulder System | 2011 |
| † | K110847 | SMR Shoulder System - Cta Humeral Heads | 2011 |
| † | K113254 | SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone Screws | 2012 |
| † | K133349 | SMR TT Metal Back Glenoid | 2014 |
| † | K143256 | SMR Modular Glenoid | 2015 |
| † | K153722 | SMR 3-Pegs Glenoids | 2016 |
| † | K163397 | SMR Hybrid Glenoid System | 2017 |
| † | K161476 | SMR Shoulder System | 2016 |
| † | K143552 | Simpliciti Shoulder System | 2015 |
| † | K171858 | Sidus Stem-Free Shoulder | 2017 |
| † | K173388 | Exactech Equinoxe Stemless Shoulder | 2018 |
| † | K212800 | PRIMA Humeral System and SMR Glenosphere Ø42 | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 7 companies; a new generation was cleared every 3.9 years on median.
- 5 of the 25 ancestors have a recall of any class.
- 3 other devices also cite its predicate K183194.
How does its category compare?
All PKC devicesPKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · PKC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PKC
167in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PKC
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PKC
86in 2025
MAUDE reports naming product code PKC, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 5 |
| 2019 | 1 | — | 1 | 8 |
| 2020 | 4 | 116 | 0 | 5 |
| 2021 | 2 | — | 0 | 14 |
| 2022 | 3 | 148 | 0 | 31 |
| 2023 | 1 | — | 0 | 46 |
| 2024 | 3 | 167 | 0 | 54 |
| 2025 | 1 | — | 0 | 86 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The SMR Stemless Anatomic is indicated for total primary or revision shoulder joint replacement in patients suffering from disability due to:
* non-inflammatory degenerative joint disease including osteoarthritis;
* revision of previous surgeries of the shoulder that do not compromise the fixation (such as a failed SMR resurfacing implant);
+ glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid Glenoid only).
The SMR Stemless Anatomic is intended for uncemented use.
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/K221758 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221758: SMR Stemless Anatomic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221758
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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