510(k) · Cleared
Recalled · Class II · 2018Aequalis Humeral Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jan 27, 2009 as substantially equivalent to K042396 (Howmedica Osteonics Corp., 2004) and 2 other predicates after a 130-day review. Its family tree reaches back 2 generations to 1995. 22 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 27, 2009
- Review
- 130 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 2 generations to K951740 (1995). 7 ancestors in all. 22 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK951740 Intramedulary Fixation RodAcu Med, Inc. · 1995 · Recalled
- 1 generation backK032722 Trigen Straight Humeral Nail SystemSmith & Nephew, Inc. · 2003
- This deviceK082754 Aequalis Humeral Nail SystemTornier · 2009
- Descendant · cites it directly · 17 of its ownK103002 Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 2011 · Recalled
- Descendant · 2 generations on · 15 of its ownK120807 Synthes Multiloc Humeral Nailing SystemSynthes USA Products, LLC · 2012
- Descendant · 3 generations on · 10 of its ownK132945 CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated…I.T.S. GmbH · 2014
- Descendant · 4 generations on · 3 of its ownK161327 Syntec Humeral Nail SystemSyntec Scientific Corporation · 2017
- Descendant · cites it directly · 3 of its ownK133376 Aequalis Humeral Nail; Sizes 7MM & 8MM X 210, 230, 250, 270MM; Left…Tornier, Inc. · 2013
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 2011 · cites it directly17descendants
- K120807Synthes Multiloc Humeral Nailing SystemSynthes USA Products, LLC · 2012 · 2 generations on15descendants
- K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH · 2014 · 3 generations on10descendants
- K161327Syntec Humeral Nail SystemSyntec Scientific Corporation · 2017 · 4 generations on3descendants
- K133376Aequalis Humeral Nail; Sizes 7MM & 8MM X 210, 230, 250, 270MM; Left and RightTornier, Inc. · 2013 · cites it directly3descendants
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 | K032722 | Trigen Straight Humeral Nail System | Smith & Nephew, Inc. | 2003 | — |
| 0 (this device) | K082754 | Aequalis Humeral Nail System | Tornier | 2009 | — |
| +1 | K103002 | Synthes Multiloc Proximal Humeral Nailing System | Synthes (Usa) | 2011 | 2 |
| +2 | K120807 | Synthes Multiloc Humeral Nailing System | Synthes USA Products, LLC | 2012 | — |
| +3 | K132945 | CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral… | I.T.S. GmbH | 2014 | — |
| +4 | K161327 | Syntec Humeral Nail System | Syntec Scientific Corporation | 2017 | — |
| +1 | K133376 | Aequalis Humeral Nail; Sizes 7MM & 8MM X 210, 230, 250, 270MM; Left and Right | Tornier, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 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? (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 |
|---|---|---|---|
| * | K042396 | T2 Proximal Humeral NailSummary page 1…ullary Fixation Rod and Accessories PREDICATE DEVICES: * Howmedica Osteonics T2 Proximal Humeral Nail (K042396) * FH Industrie Titanium Telegraph Humeral Nail (K042332)… | 2004 |
| * | K042332 | Titanium Telegraph Humeral NailSummary page 1…meral Nail (K042396) * FH Industrie Titanium Telegraph Humeral Nail (K042332) * Smith & Nephew TriGen Straight Humeral Nail System (K032722… | 2004 |
| * | K032722 | Trigen Straight Humeral Nail SystemSummary page 1…Nail (K042332) * Smith & Nephew TriGen Straight Humeral Nail System (K032722) DEVICE DESCRIPTION: The Aequalis Humeral Nail System includes intramedullary nails and screws. The Aequalis Humeral Nail is a s… | 2003 |
What descends from it? (22)
See all 222 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 26, 2018 | Class II | Z-1757-2018 | Package design/selection | Drill bit tips without new BargerGard tip protector may puncture through sterile packaging. |
| Jun 25, 2015 | Class II | Z-2315-2015 | Nonconforming Material/Component | Recall for the Aequalis IM Nail instrumentation set (Tray Number 9020000) due to several reports that the mast of the targeting jig (Part Number 9020060) is separating from the jig boom. Separation will impact alignment and can affect the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 8.1 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K103002 (Synthes (Usa), 2011) has gone furthest, with 17 descendants of its own.
- 3 other devices also cite its predicate K042396.
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. 2009, this device’s year, is highlighted.
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 Aequalis Humeral Nail System is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact calotte, or Humeral Fractures according to Neer-Classification (2, 3 and 4 part fractures).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082754 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082754: Aequalis 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/K082754
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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