510(k) · Cleared
ClearedHumeral Staple
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · HTY Pin, Fixation, Smooth
Cleared on Jul 30, 2004 as substantially equivalent to K032687 (DePuy Orthopaedics, Inc., 2003) and 2 other predicates after a 71-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Jul 30, 2004
- Review
- 71 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K960642 (1996). 4 ancestors in all, the oldest K811002 (1981). 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 |
|---|---|---|---|---|---|
| −3 | K960642 | Nancy Nail | Landos, Inc. | 1996 | — |
| −2 | K971783 | Synthes Elastic Intramedullary Nail (Ein) System | Synthes (Usa) | 1997 | — |
| −1 | K032687 | Ace Nancy Nail | DePuy Orthopaedics, Inc. | 2003 | — |
| 0 (this device) | K041355 | Humeral Staple | Smith & Nephew, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 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 HTY? 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 HTY device
- #1 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K032687 | Ace Nancy NailSummary page 1…igned for intramedullary implantation in the proximal humerus. SUBSTANTIAL EQUIVALENCE INFORMATION: The humeral staple is similar to the DePuy ACE, Inc., The Nancy Nail (K032687); Synthes, Elastic Intramedullary Nail (K971783); Smith & Nephew, Inc., Ender Nail (K811002); and Smith & Nephew, Inc., Steinman… | 2003 |
| * | K971783 | Synthes Elastic Intramedullary Nail (Ein) SystemSummary page 1…ximal humerus. SUBSTANTIAL EQUIVALENCE INFORMATION: The humeral staple is similar to the DePuy ACE, Inc., The Nancy Nail (K032687); Synthes, Elastic Intramedullary Nail (K971783); Smith & Nephew, Inc., Ender Nail (K811002); and Smith & Nephew, Inc., Steinman Pin (preamendment device) in that all the device… | 1997 |
| * | K811002 | Ender PinsSummary page 1…MATION: The humeral staple is similar to the DePuy ACE, Inc., The Nancy Nail (K032687); Synthes, Elastic Intramedullary Nail (K971783); Smith & Nephew, Inc., Ender Nail (K811002); and Smith & Nephew, Inc., Steinman Pin (preamendment device) in that all the devices are made of stainless steel or titanium, o… | 1981 |
| * | — | Steinman Pin 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 8 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- None of the 4 ancestors has a recall.
- 4 other devices also cite its predicate K032687.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HTY
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HTY
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTY
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTY
39in 2025
MAUDE reports naming product code HTY, 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 | 6 | 112 | 0 | 46 |
| 2008 | 6 | 86 | 0 | 38 |
| 2009 | 2 | — | 1 | 36 |
| 2010 | 9 | 180 | 1 | 33 |
| 2011 | 6 | 82 | 0 | 164 |
| 2012 | 4 | 76 | 0 | 129 |
| 2013 | 4 | 128 | 0 | 187 |
| 2014 | 8 | 73 | 0 | 149 |
| 2015 | 8 | 101 | 0 | 121 |
| 2016 | 6 | 114 | 2 | 128 |
| 2017 | 5 | 127 | 0 | 82 |
| 2018 | 4 | 162 | 0 | 138 |
| 2019 | 4 | 93 | 1 | 222 |
| 2020 | 5 | 108 | 0 | 210 |
| 2021 | 5 | 137 | 0 | 148 |
| 2022 | 4 | 121 | 2 | 96 |
| 2023 | 5 | 146 | 0 | 153 |
| 2024 | 1 | — | 0 | 297 |
| 2025 | 5 | 90 | 0 | 39 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
Humeral staples are intended for fixation of two-part proximal humerus fractures and
three-part proximal humerus fractures in conjunction with limited internal fixation such as
suture wires. The device is intended for single use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041355 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041355: Humeral Staple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041355
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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