510(k) · Cleared
ClearedAce Humeral Nail
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ace Orthopedic Manufacturing Co. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Mar 22, 1994 after a 174-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 15 later devices descend from it.
- Decided
- Mar 22, 1994
- Review
- 174 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 2 citing it directly.
- This deviceK934643 Ace Humeral NailAce Orthopedic Manufacturing Co. · 1994
- Descendant · cites it directly · 10 of its ownK033878 Ace Antegrade Retrograde Humeral Nail SystemDepuy Ace · 2004
- Descendant · 2 generations on · 6 of its ownK181827 Affixus Natural Nail System Humeral NailZimmer GmbH · 2018
- Descendant · 3 generations on · 4 of its ownK231114 Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus®…Zimmer Switzerland Manufacturing GmbH · 2023
- Descendant · cites it directly · 3 of its ownK051965 Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation…Merete Medical GmbH · 2006
- Descendant · 4 generations on · 2 of its ownK241651 Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc. · 2024 · Recalled
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K033878Ace Antegrade Retrograde Humeral Nail SystemDepuy Ace · 2004 · cites it directly10descendants
- K181827Affixus Natural Nail System Humeral NailZimmer GmbH · 2018 · 2 generations on6descendants
- K231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail…Zimmer Switzerland Manufacturing GmbH · 2023 · 3 generations on4descendants
- K051965Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation Rod SystemMerete Medical GmbH · 2006 · cites it directly3descendants
- K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc. · 2024 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934643 | Ace Humeral Nail | Ace Orthopedic Manufacturing Co. | 1994 | — |
| +1 | K033878 | Ace Antegrade Retrograde Humeral Nail System | Depuy Ace | 2004 | — |
| +2 | K181827 | Affixus Natural Nail System Humeral Nail | Zimmer GmbH | 2018 | — |
| +3 | K231114 | Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail®… | Zimmer Switzerland Manufacturing GmbH | 2023 | — |
| +1 | K051965 | Osteobridge Idsf Intramedullary Diaphyseal Segmental Defect Fixation Rod System | Merete Medical GmbH | 2006 | — |
| +4 | K241651 | Affixus Tibial and Antegrade Femoral Nailing System | Zimmer, Inc. | 2024 | 17 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HSB? 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 HSB device
- #1 K200869 Gamma3 Systemscore 19.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (15)
See all 152 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K033878 (Depuy Ace, 2004) has gone furthest, with 10 descendants of its own.
How does its category compare?
All HSB devicesHSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HSB
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSB
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSB
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSB
2,911in 2025
MAUDE reports naming product code HSB, 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 | 8 | 68 | 0 | 162 |
| 2008 | 11 | 57 | 9 | 184 |
| 2009 | 18 | 86 | 81 | 334 |
| 2010 | 14 | 117 | 18 | 454 |
| 2011 | 16 | 78 | 2 | 662 |
| 2012 | 17 | 112 | 7 | 1,079 |
| 2013 | 18 | 105 | 14 | 1,773 |
| 2014 | 19 | 147 | 3 | 1,474 |
| 2015 | 22 | 111 | 3 | 1,671 |
| 2016 | 8 | 124 | 6 | 1,920 |
| 2017 | 23 | 119 | 66 | 1,447 |
| 2018 | 17 | 134 | 56 | 3,526 |
| 2019 | 13 | 132 | 6 | 2,517 |
| 2020 | 17 | 112 | 6 | 3,299 |
| 2021 | 10 | 94 | 2 | 4,111 |
| 2022 | 12 | 172 | 1 | 2,733 |
| 2023 | 11 | 162 | 1 | 2,219 |
| 2024 | 13 | 195 | 1 | 2,869 |
| 2025 | 15 | 106 | 18 | 2,911 |
| 2026 | 18 | 151 | 1 | — |
https://510kreport.com/device/K934643 · printed Nov 6, 2026
Cite this page
510(k) Report. “K934643: Ace Humeral Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934643
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026