510(k) · Cleared
ClearedAce Proximal Humeral Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Ace · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Feb 20, 2004 as substantially equivalent to K951740 (Acu Med, Inc., 1995) and 1 other predicate after a 74-day review. Its family tree reaches back 2 generations to 1995. 9 later devices descend from it.
- Decided
- Feb 20, 2004
- Review
- 74 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K951740 (1995). 3 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK951740 Intramedulary Fixation RodAcu Med, Inc. · 1995 · Recalled
- 1 generation backK023241 Telegraph Humeral NailFournitures Hospitalieres Industrie · 2002
- This deviceK033806 Ace Proximal Humeral Nail SystemDepuy Ace · 2004
- Descendant · cites it directly · 6 of its ownK181827 Affixus Natural Nail System Humeral NailZimmer GmbH · 2018
- Descendant · 2 generations on · 4 of its ownK231114 Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus®…Zimmer Switzerland Manufacturing GmbH · 2023
- Descendant · 3 generations on · 2 of its ownK241651 Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc. · 2024 · Recalled
- Descendant · 2 generations on · 1 of its ownK200814 Affixus (R) Natural Nail (R) System Humeral NailZimmer GmbH · 2020
- Descendant · cites it directly · 1 of its ownK111663 Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc. · 2012 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K181827Affixus Natural Nail System Humeral NailZimmer GmbH · 2018 · cites it directly6descendants
- K231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail…Zimmer Switzerland Manufacturing GmbH · 2023 · 2 generations on4descendants
- K241651Affixus Tibial and Antegrade Femoral Nailing SystemZimmer, Inc. · 2024 · 3 generations on2descendants
- K200814Affixus (R) Natural Nail (R) System Humeral NailZimmer GmbH · 2020 · 2 generations on1descendant
- K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc. · 2012 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951740 | Intramedulary Fixation Rod | Acu Med, Inc. | 1995 | 1 |
| −1 | K023241 | Telegraph Humeral Nail | Fournitures Hospitalieres Industrie | 2002 | — |
| 0 (this device) | K033806 | Ace Proximal Humeral Nail System | Depuy Ace | 2004 | — |
| +1 | K181827 | Affixus Natural Nail System Humeral Nail | Zimmer GmbH | 2018 | — |
| +2 | K231114 | Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail®… | Zimmer Switzerland Manufacturing GmbH | 2023 | — |
| +3 | K241651 | Affixus Tibial and Antegrade Femoral Nailing System | Zimmer, Inc. | 2024 | 17 |
| +2 | K200814 | Affixus (R) Natural Nail (R) System Humeral Nail | Zimmer GmbH | 2020 | — |
| +1 | K111663 | Trauma Internal Fixation Systems | DePuy Orthopaedics, Inc. | 2012 | 17 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K951740 | Intramedulary Fixation RodSummary page 1…Intramedullary Fixation Rod DEVICE PRODUCT CODE: 87 HSB SUBSTANTIALLY EQUIVALENT Acumed Polarus, K951740 DEVICE: Foumitures Hospitali6res Industrie Telegraph®… | 1995 |
| * | K023241 | Telegraph Humeral NailSummary page 1…Acumed Polarus, K951740 DEVICE: Foumitures Hospitali6res Industrie Telegraph® Humeral Nail, K023241 DEVICE DESCRIPTION: The ACE® Proximal Humeral Nail System consists of an intramedullary nail, a sleeve, and an end cap and is in… | 2002 |
What descends from it? (9)
3 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?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 7.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K181827 (Zimmer GmbH, 2018) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K951740.
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 | — |
What is it indicated for?
The ACE® Proximal Humeral Nail System is intended for the fixation of proximal humeral fractures.
These implants are intended as a guide to normal healing and are not intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033806 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033806: Ace Proximal Humeral Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033806
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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