510(k) · Cleared
ClearedOlecra Intramedullary Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mylad Orthopedic Solutions · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Mar 4, 2011 as substantially equivalent to K063460 (Acumed, LLC, 2006) and 1 other predicate after a 29-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Mar 4, 2011
- Review
- 29 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K951740 (1995). 30 ancestors in all, the oldest K890939 (1989). No later device cites it as a predicate yet.
- Root · 5 generations backK951740 Intramedulary Fixation RodAcu Med, Inc. · 1995 · Recalled
- 4 generations backK032722 Trigen Straight Humeral Nail SystemSmith & Nephew, Inc. · 2003
- 3 generations backK051557 Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc. · 2005
- 2 generations backK061019 Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc. · 2006 · Recalled
- 1 generation backK090091 Olecranail Intramedullary Fixation SystemMylad Orthopedic Solutions, LLC · 2009
- This deviceK110322 Olecra Intramedullary Fixation SystemMylad Orthopedic Solutions · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K951740 | Intramedulary Fixation Rod | Acu Med, Inc. | 1995 | 1 |
| −4 | K032722 | Trigen Straight Humeral Nail System | Smith & Nephew, Inc. | 2003 | — |
| −3 | K051557 | Trigen Retrograde Femoral, Supracondylar and Tibial Nails | Smith & Nephew, Inc. | 2005 | — |
| −2 | K061019 | Trigen Meta-Nail Retrograde Femoral and Tibial Nails | Smith & Nephew, Inc. | 2006 | 1 |
| −1 | K090091 | Olecranail Intramedullary Fixation System | Mylad Orthopedic Solutions, LLC | 2009 | — |
| 0 (this device) | K110322 | Olecra Intramedullary Fixation System | Mylad Orthopedic Solutions | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1995 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 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? (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 |
|---|---|---|---|
| * | K063460 | Acumed Congruent Bone Plate SystemSummary page 1…Biomet Premier Total Knee Instrumentation Acumed Congruent Bone Plate System (K063460) Mylad OlecraNail® Intramedullary Fixation… | 2006 |
| * | K090091 | Olecranail Intramedullary Fixation SystemSummary page 1…(K063460) Mylad OlecraNail® Intramedullary Fixation System (K090091) Summary of Device: The OlecraNail®W intramedullary nail is a fixation device that has been previously cleared for marketing (K0… | 2009 |
| * | — | Acumed ulna shortening osteotomy guide Named without a submission number | |
| * | — | Biomet Premier Total Knee Instrumentation 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 16 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 11 of the 30 ancestors have a recall of any class.
- 4 other devices also cite its predicate K063460.
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. 2011, 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 OlecraNail® Intramedullary Fixation System and accessories are intended for the
surgical fixation of all fractures and surgical osteotomies of the proximal ulna in the acute
or chronic setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110322 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110322: Olecra Intramedullary Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110322
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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