510(k) · Cleared
ClearedZimmer Trabecular Metal Reverse Shoulder System, Base Plates & Humeral Stems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Cleared on Oct 11, 2012 as substantially equivalent to K052906 (Zimmer, Inc., 2005) and 1 other predicate after a 139-day review. Its family tree reaches back 8 generations to 1991. 14 later devices descend from it.
- Decided
- Oct 11, 2012
- Review
- 139 days
- Class
- Class II
- Product code
- KWT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K911686 (1991). 28 ancestors in all, the oldest K790987 (1979). 14 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 7 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 6 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 5 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 4 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 3 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 2 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 1 generation backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- This deviceK121543 Zimmer Trabecular Metal Reverse Shoulder System, Base Plates &…Zimmer, Inc. · 2012
- Descendant · cites it directly · 11 of its ownK133378 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2014
- Descendant · 2 generations on · 10 of its ownK181611 Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp · 2018
- Descendant · 3 generations on · 3 of its ownK210533 Inset Reverse Total Shoulder SystemShoulder Innovations, Inc. · 2021
- Descendant · 3 generations on · 3 of its ownK200368 LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG · 2021
- Descendant · 4 generations on · 1 of its ownK252221 Inset Reverse Total Shoulder SystemShoulder Innovations, Inc. · 2025
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K133378Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2014 · cites it directly11descendants
- K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp · 2018 · 2 generations on10descendants
- K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc. · 2021 · 3 generations on3descendants
- K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG · 2021 · 3 generations on3descendants
- K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc. · 2025 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −7 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −6 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −5 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −4 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −3 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −2 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −1 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| 0 (this device) | K121543 | Zimmer Trabecular Metal Reverse Shoulder System, Base Plates & Humeral Stems | Zimmer, Inc. | 2012 | — |
| +1 | K133378 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2014 | — |
| +2 | K181611 | Comprehensive Reverse Shoulder System | Biomet Manufacturing Corp | 2018 | — |
| +3 | K210533 | Inset Reverse Total Shoulder System | Shoulder Innovations, Inc. | 2021 | — |
| +3 | K200368 | LINK Embrace Shoulder System - Reverse Configuration | Waldemar Link GmbH & Co. KG | 2021 | — |
| +4 | K252221 | Inset Reverse Total Shoulder System | Shoulder Innovations, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 4 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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 KWT? 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 KWT device
- #1 K231657 AGILON® XO Shoulder Replacement Systemscore 17.7 · 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052906 | Zimmer Trabecular Metal Reverse Shoulder SystemSummary page 4…is. 21 CFR § 888.3690 - Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis. Zimmer Trabecular Metal Reverse Shoulder System, manufactured by Zimmer, K052906, cleared December 19, 2005. Zimmer Trabecular Metal Reverse Shoulder System, manufactured by Zimmer, K060704, cleared May 19, 2… | 2005 |
| * | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMSummary page 4…ar Metal Reverse Shoulder System, manufactured by Zimmer, K052906, cleared December 19, 2005. Zimmer Trabecular Metal Reverse Shoulder System, manufactured by Zimmer, K060704, cleared May 19, 2006. The proposed Base Plates and Humeral Stems are a line extension of the Zimmer Trabecular Metal Reverse Sh… | 2006 |
What descends from it? (14)
See all 144 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133378 | Zimmer Trabecular Metal Reverse Shoulder System | 2014 | 11 |
| K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral… | 2026 | 0 |
| K172767 | Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid | 2017 | 0 |
| K130661 | Zimmer Trabecular Metal Reverse Shoulder System | 2013 | 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 21 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 8 of the 28 ancestors have a recall of any class.
- Of its descendants, K133378 (Zimmer, Inc., 2014) has gone furthest, with 11 descendants of its own.
- 12 other devices also cite its predicate K052906.
How does its category compare?
All KWT devicesKWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · KWT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWT
242in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWT
749in 2025
MAUDE reports naming product code KWT, 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 | 1 | — | 0 | 32 |
| 2008 | 0 | — | 1 | 48 |
| 2009 | 0 | — | 0 | 58 |
| 2010 | 1 | — | 7 | 71 |
| 2011 | 5 | 165 | 0 | 112 |
| 2012 | 1 | — | 2 | 83 |
| 2013 | 1 | — | 1 | 113 |
| 2014 | 1 | — | 0 | 168 |
| 2015 | 2 | — | 0 | 176 |
| 2016 | 2 | — | 1 | 445 |
| 2017 | 1 | — | 1 | 560 |
| 2018 | 2 | — | 1 | 480 |
| 2019 | 4 | 91 | 3 | 419 |
| 2020 | 1 | — | 0 | 215 |
| 2021 | 1 | — | 0 | 228 |
| 2022 | 1 | — | 0 | 273 |
| 2023 | 1 | — | 1 | 361 |
| 2024 | 1 | — | 0 | 601 |
| 2025 | 4 | 242 | 0 | 749 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Zimmer Trabecular Metal Shoulder System is indicated for the following: Hemiarthroplasty/Total application: - the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; - ununited humeral head fractures of long duration; - irreducible 3-and 4-part proximal humeral fractures; - avascular necrosis of the humeral head, or other difficult clinical management problems where…
Read the full statement (231 words)
The Zimmer Trabecular Metal Shoulder System is indicated for the following:
Hemiarthroplasty/Total application:
- the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
- ununited humeral head fractures of long duration;
- irreducible 3-and 4-part proximal humeral fractures;
- avascular necrosis of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.
Reverse application:
- the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
- ununited humeral head fractures of long duration;
- irreducible 3-and 4-part proximal humeral fractures;
- avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthroplasty or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable.
The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty (conventional or reverse applications).
The humeral components are intended for either cemented or uncemented use. The reverse base plate is intended for uncemented use, and requires two screws for fixation. When used in a total shoulder application, the all-polyethylene glenoid components are intended for cemented use only. In the USA, the Trabecular Metal Glenoid must be cemented under the base (see surgical technique for details) or fully cemented in place.
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/K121543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121543: Zimmer Trabecular Metal Reverse Shoulder System, Base Plates & Humeral Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121543
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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