510(k) · Cleared
ClearedHowmedica Humeral Intercalary System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica, Inc. · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Cleared on Feb 5, 1999 as substantially equivalent to K954559 (Howmedica Corp., 1996) and 1 other predicate after a 73-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Feb 5, 1999
- Review
- 73 days
- Class
- Class II
- Product code
- HSD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K962553 (1996). 3 ancestors in all, the oldest K954559 (1996). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K962553 | EZ-Fix Midshaft Humeral Intramedullary Rod System | Biodynamic Technologies, Inc. | 1996 | — |
| −1 | K980609 | Segmental Defect Replacement System | Metagen, LLC | 1998 | — |
| 0 (this device) | K984202 | Howmedica Humeral Intercalary System | Howmedica, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 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? (3)
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 2…System is based on an equivalence in intended use, material, design, and relative indications and contraindications to Howmedica’'s Proximal Humerus Replacement System (K954559); PMI's Proximal Humeral Segmental Replacement System (Biomet - K# unknown) and Metagen’s Segmental Defect Replacement System (K9… | 1996 |
| * | K980609 | Segmental Defect Replacement SystemSummary page 2…oximal Humerus Replacement System (K954559); PMI's Proximal Humeral Segmental Replacement System (Biomet - K# unknown) and Metagen’s Segmental Defect Replacement System (K980609). Physical and Finite Element Analysis testing of the device was presented. é Q”“.‘"Q"Oq 5 { -] o DEPARTMENT O… | 1998 |
| * | — | PMI's Proximal Humeral Segmental Replacement System (Biomet) Named without a submission number |
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 3 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 3 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 Howmedica Humeral Intercalary System is intended to be used in the management of segmental bone loss of the humerus in Oncology patients secondary to radical bone loss and/or resection due to tumors. This system is intended to be used in the management of shoulder girdle resections such as the Tikhoff-Linberg procedure, which involves removal of the bone and soft tissues of the proximal humerus and shoulder girdle. The Howmedica Humeral Intercalary System is intended to be used with bone cement. There is no glenoid component associated with this system.
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/K984202 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984202: Howmedica Humeral Intercalary System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984202
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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