510(k) · Cleared
Recalled · Class II · 2012Anatomical Press-Fit Humeral Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sulzer Orthopedics, Inc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Feb 28, 2001 after an 82-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 366 devices in its family, counting itself, has a Class I recall. 365 later devices descend from it. It has been recalled once.
- Decided
- Feb 28, 2001
- Review
- 82 days
- Class
- Class II
- Product code
- KWS
- Recalls
- 1
- Predicates
- 0
365 later devices descend from it, 3 citing it directly. 1 of the 366 devices in this family, counting this one, has a Class I recall.
- This deviceK003801 Anatomical Press-Fit Humeral StemSulzer Orthopedics, Inc. · 2001
- Descendant · cites it directly · 331 of its ownK030259 Amatomical Shoulder with Removable HeadCenterplus Orthopedics, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 239 of its ownK053274 Anatomical Shoulder Inverse/ReverseZimmer GmbH · 2006 · Recalled
- Descendant · 2 generations on · 200 of its ownK060874 Depuy Global AP Shoulder SystemDePuy Orthopaedics, Inc. · 2006
- Descendant · 3 generations on · 190 of its ownK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 178 of its ownK071948 Aequalis Reversed AdapterTornier · 2007
Showing 5 of 365 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder3 generations on · 2008
Most influential descendants
Showing 5 of 365 · See all- K030259Amatomical Shoulder with Removable HeadCenterplus Orthopedics, Inc. · 2003 · cites it directly331descendants
- K053274Anatomical Shoulder Inverse/ReverseZimmer GmbH · 2006 · 2 generations on239descendants
- K060874Depuy Global AP Shoulder SystemDePuy Orthopaedics, Inc. · 2006 · 2 generations on200descendants
- K063569Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · 3 generations on190descendants
- K071948Aequalis Reversed AdapterTornier · 2007 · 3 generations on178descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003801 | Anatomical Press-Fit Humeral Stem | Sulzer Orthopedics, Inc. | 2001 | — |
| +1 | K030259 | Amatomical Shoulder with Removable Head | Centerplus Orthopedics, Inc. | 2003 | 3 |
| +2 | K053274 | Anatomical Shoulder Inverse/Reverse | Zimmer GmbH | 2006 | 3 |
| +2 | K060874 | Depuy Global AP Shoulder System | DePuy Orthopaedics, Inc. | 2006 | — |
| +3 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| +3 | K071948 | Aequalis Reversed Adapter | Tornier | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 6 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 1 |
| 2010 | 12 | 0 |
| 2011 | 19 | 0 |
| 2012 | 18 | 0 |
| 2013 | 19 | 0 |
| 2014 | 17 | 0 |
| 2015 | 15 | 0 |
| 2016 | 17 | 0 |
| 2017 | 19 | 0 |
| 2018 | 21 | 0 |
| 2019 | 22 | 0 |
| 2020 | 23 | 0 |
| 2021 | 30 | 0 |
| 2022 | 23 | 0 |
| 2023 | 21 | 0 |
| 2024 | 20 | 0 |
| 2025 | 24 | 0 |
| 2026 | 26 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (365)
See all 3653 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 4, 2012 | Class II | Z-0225-2013 | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K030259 (Centerplus Orthopedics, Inc., 2003) has gone furthest, with 331 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K003801 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003801: Anatomical Press-Fit Humeral Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003801
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026