510(k) · Cleared
ClearedAequalis Humeral Nail; Sizes 7MM & 8MM X 210, 230, 250, 270MM; Left and Right
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Dec 5, 2013 as substantially equivalent to K082754 (Tornier, 2009) after a 31-day review. Its family tree reaches back 3 generations to 1995. 3 later devices descend from it.
- Decided
- Dec 5, 2013
- Review
- 31 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K951740 (1995). 8 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK951740 Intramedulary Fixation RodAcu Med, Inc. · 1995 · Recalled
- 2 generations backK032722 Trigen Straight Humeral Nail SystemSmith & Nephew, Inc. · 2003
- 1 generation backK082754 Aequalis Humeral Nail SystemTornier · 2009 · Recalled
- This deviceK133376 Aequalis Humeral Nail; Sizes 7MM & 8MM X 210, 230, 250, 270MM; Left…Tornier, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK230352 Tornier Humeral Nail and Tornier Long Humeral NailTornier, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK251400 T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH · 2025
- Descendant · cites it directly · 0 of its ownK200127 TELEGRAPH® EVOLUTION Humeral Nailing SystemFH Industrie · 2020
Most influential descendants
Showing 3 of 3 · See all- K230352Tornier Humeral Nail and Tornier Long Humeral NailTornier, Inc. · 2023 · cites it directly1descendant
- K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH · 2025 · 2 generations on0descendants
- K200127TELEGRAPH® EVOLUTION Humeral Nailing SystemFH Industrie · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K951740 | Intramedulary Fixation Rod | Acu Med, Inc. | 1995 | 1 |
| −2 | K032722 | Trigen Straight Humeral Nail System | Smith & Nephew, Inc. | 2003 | — |
| −1 | K082754 | Aequalis Humeral Nail System | Tornier | 2009 | 2 |
| 0 (this device) | K133376 | Aequalis Humeral Nail; Sizes 7MM & 8MM X 210, 230, 250, 270MM; Left and Right | Tornier, Inc. | 2013 | — |
| +1 | K230352 | Tornier Humeral Nail and Tornier Long Humeral Nail | Tornier, Inc. | 2023 | — |
| +2 | K251400 | T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System | Stryker GmbH | 2025 | — |
| +1 | K200127 | TELEGRAPH® EVOLUTION Humeral Nailing System | FH Industrie | 2020 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K082754 | Aequalis Humeral Nail SystemSummary page 1…21 CFR.888.3020 Legally Marketed Deviceto. Which-Your Finn Is Tornier!Aequalis Humera.l Nail System, K(082754 Claiming Equivalence: _____________________________ Description of The Device: ,The Tomier Ae… | 2009 |
What descends from it? (3)
2 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 18 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K230352 (Tornier, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K082754.
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. 2013, 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 Tornier 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 humeral head, 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/K133376 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133376: Aequalis Humeral Nail; Sizes 7MM & 8MM X 210, 230, 250, 270MM; Left and Right.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133376
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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