510(k) · Cleared
Recalled · Class II · 2012Anatomical Shoulder Keeled Glenoid
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer GmbH · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Jul 19, 2005 as substantially equivalent to K990136 (Sulzer Orthopedics, Inc., 1999) after a 29-day review. Its family tree reaches back 1 generation to 1999. 3 later devices descend from it. It has been recalled once.
- Decided
- Jul 19, 2005
- Review
- 29 days
- Class
- Class II
- Product code
- KWS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K990136 (1999). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK990136 Anatomica Glenoid ComponentSulzer Orthopedics, Inc. · 1999 · Recalled
- This deviceK051623 Anatomical Shoulder Keeled GlenoidZimmer GmbH · 2005
- Descendant · cites it directly · 2 of its ownK170711 ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical…Zimmer GmbH · 2017
- Descendant · 2 generations on · 1 of its ownK193099 Anatomical Shoulder SystemZimmer GmbH · 2020
- Descendant · 3 generations on · 0 of its ownK260556 Veritas Shoulder SystemRestor3D · 2026
Most influential descendants
Showing 3 of 3 · See all- K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH · 2017 · cites it directly2descendants
- K193099Anatomical Shoulder SystemZimmer GmbH · 2020 · 2 generations on1descendant
- K260556Veritas Shoulder SystemRestor3D · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990136 | Anatomica Glenoid Component | Sulzer Orthopedics, Inc. | 1999 | 2 |
| 0 (this device) | K051623 | Anatomical Shoulder Keeled Glenoid | Zimmer GmbH | 2005 | — |
| +1 | K170711 | ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder… | Zimmer GmbH | 2017 | — |
| +2 | K193099 | Anatomical Shoulder System | Zimmer GmbH | 2020 | — |
| +3 | K260556 | Veritas Shoulder System | Restor3D | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 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 KWS? 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? (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 |
|---|---|---|---|
| * | K990136 | Anatomica Glenoid ComponentSummary page 1…Predicate Device: Anatomica All-Polyethylene Glenoid Component, manufactured by Zimmer GmbH, K990136, cleared March 1, 1999 Device Description: The keeled… | 1999 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170711 | ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System | 2017 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 4, 2012 | Class II | Z-0226-2013 | 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
This device is intended for cemented use in treatment of the following:
* 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 as stated in the FDA summary.
https://510kreport.com/device/K051623 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051623: Anatomical Shoulder Keeled Glenoid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051623
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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