510(k) · Cleared
ClearedHowmedicca Modular Proximal Humerus Replacement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Corp. · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Cleared on Jul 12, 1996 after a 284-day review. The FDA summary names its predicate without a number. 110 later devices descend from it.
- Decided
- Jul 12, 1996
- Review
- 284 days
- Class
- Class II
- Product code
- HSD
- Recalls
- None
- Predicates
- 0
110 later devices descend from it, 5 citing it directly.
- This deviceK954559 Howmedicca Modular Proximal Humerus Replacement SystemHowmedica Corp. · 1996
- Descendant · cites it directly · 102 of its ownK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
- Descendant · 2 generations on · 101 of its ownK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
- Descendant · 3 generations on · 54 of its ownK022549 Restoration Modular SystemHowmedica Osteonics Corp. · 2002 · Recalled
- Descendant · 3 generations on · 53 of its ownK103479 Novel Tapered Hip StemStryker Corp. · 2011
- Descendant · 3 generations on · 46 of its ownK120578 Accolade II Hip StemHowmedica Osteonics · 2012 · Recalled
Showing 5 of 110 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 110 · See all- K983404Type 3 Femoral ComponentsHowmedica Corp. · 1998 · cites it directly102descendants
- K0131062 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · 2 generations on101descendants
- K022549Restoration Modular SystemHowmedica Osteonics Corp. · 2002 · 3 generations on54descendants
- K103479Novel Tapered Hip StemStryker Corp. · 2011 · 3 generations on53descendants
- K120578Accolade II Hip StemHowmedica Osteonics · 2012 · 3 generations on46descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954559 | Howmedicca Modular Proximal Humerus Replacement System | Howmedica Corp. | 1996 | — |
| +1 | K983404 | Type 3 Femoral Components | Howmedica Corp. | 1998 | 1 |
| +2 | K013106 | 2 Piece Modular Hip Stem | Howmedica Osteonics Corp. | 2002 | 37 |
| +3 | K022549 | Restoration Modular System | Howmedica Osteonics Corp. | 2002 | 3 |
| +3 | K103479 | Novel Tapered Hip Stem | Stryker Corp. | 2011 | — |
| +3 | K120578 | Accolade II Hip Stem | Howmedica Osteonics | 2012 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 8 | 0 |
| 2016 | 8 | 0 |
| 2017 | 9 | 0 |
| 2018 | 4 | 0 |
| 2019 | 9 | 0 |
| 2020 | 7 | 0 |
| 2021 | 6 | 0 |
| 2022 | 9 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 0 |
| 2025 | 12 | 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 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? (8)
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 |
|---|---|---|---|
| * | — | Proximal Humerus Replacement (Howmedica) Named without a submission number | |
| * | — | Neer II Proximal Humerus (Howmedica) Named without a submission number | |
| * | — | Neer III Modular Proximal Humerus (Kirschner) Named without a submission number | |
| * | — | Select Shoulder (Intermedics) Named without a submission number | |
| * | — | NJ Shoulder (DePuy) Named without a submission number | |
| * | — | PMI Proximal Humeral Segmental System (Biomet) Named without a submission number | |
| * | — | Precision Osteolock™ Femoral Stems (Howmedica) Named without a submission number | |
| * | — | P.C.A.® E-Series Hip (Howmedica) Named without a submission number |
What descends from it? (110)
See all 1105 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983404 | Type 3 Femoral Components | 1998 | 102 |
| K051965 | Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation Rod System | 2006 | 3 |
| K032264 | Modular Replacement System (MRS) Humeral Stem | 2003 | 1 |
| K040128 | Modification to Modular Replacement System (MRS) Humeral Stems | 2004 | 0 |
| K984202 | Howmedica Humeral Intercalary System | 1999 | 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?
- Of its descendants, K983404 (Howmedica Corp., 1998) has gone furthest, with 102 descendants of its own.
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?
These segments can be combined to replace the proximal humerus secondary to extensive bone loss or bone disease. Bone loss may be due to tumor resection, revision arthroplasty or trauma. This device is indicated for use with bone cement.
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/K954559 · printed Nov 6, 2026
Cite this page
510(k) Report. “K954559: Howmedicca Modular Proximal Humerus Replacement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954559
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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