510(k) · Cleared
ClearedOlecranail Intramedullary Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mylad Orthopedic Solutions, LLC · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jul 9, 2008 as substantially equivalent to K073402 (Synthes (Usa), 2008) and 3 other predicates after a 56-day review. Its family tree reaches back 3 generations to 1992. 2 later devices descend from it.
- Decided
- Jul 9, 2008
- Review
- 56 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K913949 (1992). 8 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK913949 True/Flex Humerus, Ulna & Radius Intramed Rods SysApplied Osteo Systems, Inc. · 1992
- 2 generations backK031438 Acumed Small Bone Locking Rod System IIAcumed, LLC · 2003 · Recalled
- 1 generation backK032548 IP-XS Compression Nail SystemPlus Orthopedics · 2003
- This deviceK081356 Olecranail Intramedullary Fixation SystemMylad Orthopedic Solutions, LLC · 2008
- Descendant · cites it directly · 1 of its ownK090091 Olecranail Intramedullary Fixation SystemMylad Orthopedic Solutions, LLC · 2009
- Descendant · 2 generations on · 0 of its ownK110322 Olecra Intramedullary Fixation SystemMylad Orthopedic Solutions · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K913949 | True/Flex Humerus, Ulna & Radius Intramed Rods Sys | Applied Osteo Systems, Inc. | 1992 | — |
| −2 | K031438 | Acumed Small Bone Locking Rod System II | Acumed, LLC | 2003 | 1 |
| −1 | K032548 | IP-XS Compression Nail System | Plus Orthopedics | 2003 | — |
| 0 (this device) | K081356 | Olecranail Intramedullary Fixation System | Mylad Orthopedic Solutions, LLC | 2008 | — |
| +1 | K090091 | Olecranail Intramedullary Fixation System | Mylad Orthopedic Solutions, LLC | 2009 | — |
| +2 | K110322 | Olecra Intramedullary Fixation System | Mylad Orthopedic Solutions | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 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? (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 |
|---|---|---|---|
| * | K073402 | Synthes Olecranon Osteotomy Nailing SystemSummary page 1…s per 21 CFR section 888.3020 Legally Marketed Equivalent Devices: Synthes Intramedullary Nail for the Olecranon (K073402) Acumed Small Bone Locking Rod System… | 2008 |
| * | K071944 | Acumed Small Bone Locking System IISummary page 1…Olecranon (K073402) Acumed Small Bone Locking Rod System (K071944) Plus Orthopedics IP-XS Compression Nail… | 2007 |
| * | K032548 | IP-XS Compression Nail SystemSummary page 1…(K071944) Plus Orthopedics IP-XS Compression Nail System (K032548) Acumed Polarus Nail (K920666) Summary of Device: The OlecraNail Tm intramedullar… | 2003 |
| * | K920666 | Intramedulary Fixation RodSummary page 1…Plus Orthopedics IP-XS Compression Nail System (K032548) Acumed Polarus Nail (K920666) Summary of Device: The OlecraNail Tm intramedullary rod is a solid bore, stainless steel, tapered rod that is inserted into a… | 1992 |
| † | K983757 | Syntec-Taichung Non-Sterile Knowles Pin, Models: for Hexagonal Collar… | 1998 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090091 | Olecranail Intramedullary Fixation System | 2009 | 1 |
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 4.8 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K090091 (Mylad Orthopedic Solutions, LLC, 2009) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K073402.
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. 2008, 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 OlecraNailTM 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/K081356 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081356: Olecranail 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/K081356
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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