510(k) · Cleared
Recalled · Class II · 2019Sidus Stem-Free Shoulder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer GmbH · PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Cleared on Dec 18, 2017 as substantially equivalent to K143552 (Tornier, Inc., 2015) and 1 other predicate after a 180-day review. Its family tree reaches back 6 generations to 1991. 13 later devices descend from it. It has been recalled 3 times.
- Decided
- Dec 18, 2017
- Review
- 180 days
- Class
- Class II
- Product code
- PKC
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 6 generations to K911686 (1991). 21 ancestors in all, the oldest K790987 (1979). 13 later devices descend from it, 5 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 backK060988 Total and Hemi Shoulder SystemDvo Extremity Solutions, LLC · 2006 · Recalled
- 2 generations backK103007 Affiniti Total and Hemi-Shoulder SystemTornier, Inc. · 2010
- 1 generation backK143552 Simpliciti Shoulder SystemTornier, Inc. · 2015
- This deviceK171858 Sidus Stem-Free ShoulderZimmer GmbH · 2017
- 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 · 3 of its ownK203108 Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021
- Descendant · cites it directly · 1 of its ownK241873 OsseoFit Stemless Shoulder SystemZimmer, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK201542 Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc. · 2020
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K183194Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc. · 2019 · cites it directly8descendants
- K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp · 2019 · cites it directly6descendants
- K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021 · cites it directly3descendants
- K241873OsseoFit Stemless Shoulder SystemZimmer, Inc. · 2024 · cites it directly1descendant
- K201542Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc. · 2020 · 2 generations on1descendant
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 | K060988 | Total and Hemi Shoulder System | Dvo Extremity Solutions, LLC | 2006 | 13 |
| −2 | K103007 | Affiniti Total and Hemi-Shoulder System | Tornier, Inc. | 2010 | — |
| −1 | K143552 | Simpliciti Shoulder System | Tornier, Inc. | 2015 | — |
| 0 (this device) | K171858 | Sidus Stem-Free Shoulder | Zimmer GmbH | 2017 | — |
| +1 | K183194 | Arthrex Eclipse Shoulder Prosthesis System | Arthrex, Inc. | 2019 | — |
| +1 | K182516 | Comprehensive Nano Stemless Shoulder | Biomet Manufacturing Corp | 2019 | — |
| +1 | K203108 | Ignite Stemless Anatomic Shoulder System | Ignite Orthopedics, LLC | 2021 | — |
| +1 | K241873 | OsseoFit Stemless Shoulder System | Zimmer, Inc. | 2024 | — |
| +2 | K201542 | Arthrex Eclipse Shoulder Prosthesis System | Arthrex, Inc. | 2020 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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 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? (2)
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.
What descends from it? (13)
See all 135 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2019 | Class II | Z-0300-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| Oct 10, 2019 | Class II | Z-0318-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| Aug 21, 2019 | Class II | Z-2762-2019 | Labeling mix-ups | Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
- 4 of the 21 ancestors have a recall of any class.
- Of its descendants, K183194 (Arthrex, Inc., 2019) has gone furthest, with 8 descendants of its own.
- 9 other devices also cite its predicate K143552.
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. 2017, 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 Indications for Use of the Sidus Stem-Free Shoulder are:
- Osteoarthritis;
- Posttraumatic arthrosis;
- Focal avascular necrosis of the humeral head;
- Previous surgeries of the shoulder that do not compromise the fixation.
The Sidus Stem-Free Shoulder components (Anchors and Humeral Heads) are intended for cementless use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171858 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171858: Sidus Stem-Free Shoulder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171858
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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