510(k) · Cleared
ClearedModification to Modular Replacement System (MRS) Humeral Stems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Cleared on Mar 26, 2004 as substantially equivalent to K954559 (Howmedica Corp., 1996) and 1 other predicate after a 65-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Mar 26, 2004
- Review
- 65 days
- Class
- Class II
- Product code
- HSD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K954559 (1996). No later device cites it as a predicate yet.
- Root · 2 generations backK954559 Howmedicca Modular Proximal Humerus Replacement SystemHowmedica Corp. · 1996
- 1 generation backK032264 Modular Replacement System (MRS) Humeral StemHowmedica Osteonics Corp. · 2003
- This deviceK040128 Modification to Modular Replacement System (MRS) Humeral StemsHowmedica Osteonics Corp. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954559 | Howmedicca Modular Proximal Humerus Replacement System | Howmedica Corp. | 1996 | — |
| −1 | K032264 | Modular Replacement System (MRS) Humeral Stem | Howmedica Osteonics Corp. | 2003 | — |
| 0 (this device) | K040128 | Modification to Modular Replacement System (MRS) Humeral Stems | Howmedica Osteonics Corp. | 2004 | — |
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 HSD? 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 HSD device
- #1 K191433 AGILON® XO Shoulder Replacement Systemscore 13.8 · 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? (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 |
|---|---|---|---|
| * | K954559 | Howmedicca Modular Proximal Humerus Replacement SystemSummary page 1…Phone: (201) 831-5580 Fax: (201) 831-6038 Description/Technological Comparison Premarket notification K954559 described the Modular Replacement system (MRS) Porous Coated Humeral Stem system. Special premarket notification K032264 expanded… | 1996 |
| * | K032264 | Modular Replacement System (MRS) Humeral StemSummary page 1…/Technological Comparison Premarket notification K954559 described the Modular Replacement system (MRS) Porous Coated Humeral Stem system. Special premarket notification K032264 expanded this product line to include non-porous coated humeral stems. Both of these stems are fabricated from cobalt- chromium a… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 8 years and passes through 2 companies; a new generation was cleared every 7.1 years on median.
- None of the 2 ancestors has a recall.
- 4 other devices also cite its predicate K954559.
How does its category compare?
All HSD devicesHSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HSD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HSD
145in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSD
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSD
757in 2025
MAUDE reports naming product code HSD, 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 | 4 | 72 | 0 | 128 |
| 2008 | 3 | 92 | 2 | 259 |
| 2009 | 0 | — | 2 | 156 |
| 2010 | 0 | — | 0 | 225 |
| 2011 | 2 | — | 0 | 241 |
| 2012 | 2 | — | 0 | 254 |
| 2013 | 4 | 218 | 0 | 288 |
| 2014 | 1 | — | 0 | 434 |
| 2015 | 0 | — | 0 | 574 |
| 2016 | 3 | 145 | 0 | 784 |
| 2017 | 0 | — | 3 | 985 |
| 2018 | 1 | — | 1 | 649 |
| 2019 | 0 | — | 0 | 830 |
| 2020 | 2 | — | 1 | 658 |
| 2021 | 0 | — | 0 | 573 |
| 2022 | 1 | — | 0 | 508 |
| 2023 | 0 | — | 0 | 586 |
| 2024 | 1 | — | 0 | 693 |
| 2025 | 0 | — | 0 | 757 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The subject humeral stems (MRS Humeral Stems without porous coating) are intended for use with the components of the Modular Replacement System Humeral System. This device is intended for use in patients requiring reconstruction of the proximal humerus due to extensive bone loss as a result of tumor resection secondary to primary or metastatic skeletal lesions. This device is intended for use with bone cement. This is the same intended use as the predicate device in premarket notification K954559 and K032264.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040128 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040128: Modification to Modular Replacement System (MRS) Humeral Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040128
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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