510(k) · Cleared
Recalled · Class II · 2014Zimmer Trabecular Metal Humeral Stem
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 Sep 1, 2004 as substantially equivalent to K982981 (Zimmer, Inc., 1998) and 1 other predicate after an 84-day review. Its family tree reaches back 2 generations to 1979. 1 of the 232 devices in its family, counting itself, has a Class I recall. 218 later devices descend from it. It has been recalled 8 times.
- Decided
- Sep 1, 2004
- Review
- 84 days
- Class
- Class II
- Product code
- KWT
- Recalls
- 8
- Predicates
- 2
Its longest line of descent runs back 2 generations to K790987 (1979). 13 ancestors in all. 218 later devices descend from it, 2 citing it directly. 1 of the 232 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK790987 Zimmer R Total Shoulder IIZimmer, Inc. · 1979
- 1 generation backK982981 New Zimmer Shoulder SystemZimmer, Inc. · 1998 · Recalled
- This deviceK041549 Zimmer Trabecular Metal Humeral StemZimmer, Inc. · 2004
- Descendant · cites it directly · 216 of its ownK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 207 of its ownK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 190 of its ownK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 177 of its ownK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 175 of its ownK072804 Comprehensive RS Shoulder SystemBiomet Manufacturing Corp · 2007
Showing 5 of 218 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder2 generations on · 2008
Most influential descendants
Showing 5 of 218 · See all- K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · cites it directly216descendants
- K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · 2 generations on207descendants
- K063569Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · 2 generations on190descendants
- K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc. · 2008 · 3 generations on177descendants
- K072804Comprehensive RS Shoulder SystemBiomet Manufacturing Corp · 2007 · 2 generations on175descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K790987 | Zimmer R Total Shoulder II | Zimmer, Inc. | 1979 | — |
| −1 | K982981 | New Zimmer Shoulder System | Zimmer, Inc. | 1998 | 1 |
| 0 (this device) | K041549 | Zimmer Trabecular Metal Humeral Stem | Zimmer, Inc. | 2004 | — |
| +1 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| +2 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| +2 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| +3 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| +2 | K072804 | Comprehensive RS Shoulder System | Biomet Manufacturing Corp | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 1 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 9 | 0 |
| 2013 | 11 | 0 |
| 2014 | 10 | 0 |
| 2015 | 6 | 0 |
| 2016 | 7 | 0 |
| 2017 | 14 | 0 |
| 2018 | 12 | 0 |
| 2019 | 14 | 0 |
| 2020 | 18 | 0 |
| 2021 | 21 | 0 |
| 2022 | 17 | 0 |
| 2023 | 14 | 0 |
| 2024 | 13 | 0 |
| 2025 | 15 | 0 |
| 2026 | 18 | 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 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 |
|---|---|---|---|
| * | K982981 | New Zimmer Shoulder SystemSummary page 1…TrabecularMetar Hunmeral Stem is the New Zimmer Shoulder System (Bigliani/Flatow) (1(982981, cleared Dec. 17, 1998) and the Bio- Modular Shoulder System by Biomnet, hic.… | 1998 |
| * | K992119 | Bio-Modular Shoulder SystemSummary page 1…(1(982981, cleared Dec. 17, 1998) and the Bio- Modular Shoulder System by Biomnet, hic. (K992 119, cleared Sept. 13, 1999). Device Description: The Zimmer rabecular Metal Hurneral Stem is… | 1999 |
What descends from it? (218)
See all 2182 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 |
|---|---|---|---|---|
| Jan 10, 2014 | Class II | Z-1092-2014 | Nonconforming Material/Component | This single manufacturing lot has the potential for the bond strength between the Trabecular Metal material and substrate to be below the minimum required specification. Testing found bond strength approximately 80% of the minimum… |
| Sep 10, 2010 | Not classified | Z-0570-2011 | Device Design | The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant… |
| Sep 10, 2010 | Not classified | Z-0574-2011 | Device Design | The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant… |
| Sep 10, 2010 | Not classified | Z-0575-2011 | Device Design | The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant… |
| Sep 10, 2010 | Not classified | Z-0573-2011 | Device Design | The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant… |
| Sep 10, 2010 | Not classified | Z-0576-2011 | Device Design | The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant… |
| Sep 17, 2009 | Not classified | Z-0177-2010 | Other | Some of the devices may possess a taper which will not mate with the humeral head, as intended. |
| Sep 17, 2009 | Not classified | Z-0178-2010 | Other | Some of the devices may possess a taper which will not mate with the humeral head, as intended. |
The 5 latest of 8 recalls; the web page lists all.
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 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 1 company; a new generation was cleared every 19.5 years on median.
- 4 of the 13 ancestors have a recall of any class.
- Of its descendants, K052906 (Zimmer, Inc., 2005) has gone furthest, with 216 descendants of its own.
- 6 other devices also cite its predicate K982981.
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.
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?
Prosthetic replacement with this device may be indicated for 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 arthoplasty is not acceptable. The…
Read the full statement (109 words)
Prosthetic replacement with this device may be indicated for 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 arthoplasty is not acceptable. The assembled humcral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty. Niumeral heads with heights of 27mm or greater may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional nonconstrained arthroplasty is not acceptable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041549 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041549: Zimmer Trabecular Metal 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/K041549
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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