510(k) · Cleared
ClearedAnatomica Humeral Stem/Head Components
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 18, 1999 after a 35-day review. The FDA summary names its predicate without a number. 1 of the 366 devices in its family, counting itself, has a Class I recall. 365 later devices descend from it.
- Decided
- Feb 18, 1999
- Review
- 35 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 0
365 later devices descend from it, 4 citing it directly. 1 of the 366 devices in this family, counting this one, has a Class I recall.
- This deviceK990137 Anatomica Humeral Stem/Head ComponentsSulzer Orthopedics, Inc. · 1999
- 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 · cites it directly · 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 · cites it directly200descendants
- 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) | K990137 | Anatomica Humeral Stem/Head Components | Sulzer Orthopedics, Inc. | 1999 | — |
| +1 | K030259 | Amatomical Shoulder with Removable Head | Centerplus Orthopedics, Inc. | 2003 | 3 |
| +2 | K053274 | Anatomical Shoulder Inverse/Reverse | Zimmer GmbH | 2006 | 3 |
| +1 | 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), 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.
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? (9)
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 |
|---|---|---|---|
| * | — | Sulzer Orthopedics Select Shoulder Titanium Humeral Prosthesis Named without a submission number | |
| * | — | Sulzer Orthopedics Select Shoulder CoCr Humeral Stem Prosthesis Named without a submission number | |
| * | — | Orthomet/3M Modular Neer II Shoulder System Named without a submission number | |
| * | — | Zimmer Fenlin Total Shoulder Named without a submission number | |
| * | — | Smith & Nephew Richards Cofield Shoulder Named without a submission number | |
| * | — | Kirschner/Biomet Atlas Shoulder Named without a submission number | |
| * | — | Kirschner/Biomet Mod II-C Shoulder Named without a submission number | |
| * | — | Biomet Bio-Modular Total Shoulder Named without a submission number | |
| * | — | Depuy Global Total Shoulder System Named without a submission number |
What descends from it? (365)
See all 3654 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)
No FDA recall names this device.
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 | — |
What is it indicated for?
The Anatomica Humeral Stem/Head is intended for cemented use in treatment of the following:
1. Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis.
Omarthrosis.
Rheumatoid arthritis.
Revision of shoulder prosthesis.
Traumatology: the only cone to be used in traumatological indications is the traumatology cone.
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/K990137 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990137: Anatomica Humeral Stem/Head Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990137
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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