510(k) · Cleared
ClearedSimpliciti Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier, Inc. · PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Cleared on Mar 4, 2015 as substantially equivalent to K103007 (Tornier, Inc., 2010) after a 79-day review. Its family tree reaches back 5 generations to 1991. 24 later devices descend from it.
- Decided
- Mar 4, 2015
- Review
- 79 days
- Class
- Class II
- Product code
- PKC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K911686 (1991). 9 ancestors in all, the oldest K905786 (1991). 24 later devices descend from it, 10 citing it directly.
- Root · 5 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 4 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 3 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 2 generations backK060988 Total and Hemi Shoulder SystemDvo Extremity Solutions, LLC · 2006 · Recalled
- 1 generation backK103007 Affiniti Total and Hemi-Shoulder SystemTornier, Inc. · 2010
- This deviceK143552 Simpliciti Shoulder SystemTornier, Inc. · 2015
- Descendant · cites it directly · 13 of its ownK171858 Sidus Stem-Free ShoulderZimmer GmbH · 2017 · Recalled
- Descendant · cites it directly · 9 of its ownK173388 Exactech Equinoxe Stemless ShoulderExactech, Inc. · 2018
- Descendant · cites it directly · 8 of its ownK183194 Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc. · 2019
- Descendant · cites it directly · 6 of its ownK182516 Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp · 2019
- Descendant · cites it directly · 4 of its ownK193226 AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P. · 2020
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K171858Sidus Stem-Free ShoulderZimmer GmbH · 2017 · cites it directly13descendants
- K173388Exactech Equinoxe Stemless ShoulderExactech, Inc. · 2018 · cites it directly9descendants
- K183194Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc. · 2019 · cites it directly8descendants
- K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp · 2019 · cites it directly6descendants
- K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P. · 2020 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −4 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −3 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −2 | K060988 | Total and Hemi Shoulder System | Dvo Extremity Solutions, LLC | 2006 | 13 |
| −1 | K103007 | Affiniti Total and Hemi-Shoulder System | Tornier, Inc. | 2010 | — |
| 0 (this device) | K143552 | Simpliciti Shoulder System | Tornier, Inc. | 2015 | — |
| +1 | K171858 | Sidus Stem-Free Shoulder | Zimmer GmbH | 2017 | 3 |
| +1 | K173388 | Exactech Equinoxe Stemless Shoulder | Exactech, Inc. | 2018 | — |
| +1 | K183194 | Arthrex Eclipse Shoulder Prosthesis System | Arthrex, Inc. | 2019 | — |
| +1 | K182516 | Comprehensive Nano Stemless Shoulder | Biomet Manufacturing Corp | 2019 | — |
| +1 | K193226 | AltiVate Anatomic Canal-Sparing (CS) Shoulder | Encore Medical L.P. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 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 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 |
|---|---|---|---|
| * | K103007 | Affiniti Total and Hemi-Shoulder SystemSummary page 4…cemented prosthesis Regulatory Class: Class II Product Code: PKC III. Predicate Device Information Affiniti Shoulder System, K103007 IV. Device Description The SimplicitiTM Shoulder System is intended for use in Total Shoulder Arthroplasty of the… | 2010 |
What descends from it? (24)
See all 2410 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171858 | Sidus Stem-Free Shoulder | 2017 | 13 |
| K173388 | Exactech Equinoxe Stemless Shoulder | 2018 | 9 |
| K183194 | Arthrex Eclipse Shoulder Prosthesis System | 2019 | 8 |
| K182516 | Comprehensive Nano Stemless Shoulder | 2019 | 6 |
| K193226 | AltiVate Anatomic Canal-Sparing (CS) Shoulder | 2020 | 4 |
| K240716 | AETOS Shoulder System Stemless Humeral Prosthesis | 2024 | 3 |
| K203108 | Ignite Stemless Anatomic Shoulder System | 2021 | 3 |
| K220418 | Tornier Perform Humeral System – Stemless | 2022 | 0 |
| K213615 | Shoulder Innovations Total Shoulder System | 2022 | 0 |
| K212683 | GLOBAL ICON Stemless Shoulder System | 2022 | 0 |
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 24 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K171858 (Zimmer GmbH, 2017) has gone furthest, with 13 descendants of its own.
- 1 other device also cites its predicate K103007.
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. 2015, 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 SimplicitiTM Shoulder System is indicated for severely painful and/or disabled joint
resulting from osteoarthritis or traumatic arthritis.
The metaphyseal humeral stems are indicated for press-fit, un-cemented use.
The glenoid components are indicated for cemented use only and are indicated only for
use with bone cement.
This device is for single use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143552 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143552: Simpliciti Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143552
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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