510(k) · Cleared
ClearedIntraosseous Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthohelix Surgical Designs, Inc. · HTY Pin, Fixation, Smooth
Cleared on Aug 21, 2014 as substantially equivalent to K120165 (Orthohelix Surgical Designs, Inc., 2012) and 5 other predicates after a 125-day review. Its family tree reaches back 8 generations to 1996.
- Decided
- Aug 21, 2014
- Review
- 125 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 8 generations to K954385 (1996). 55 ancestors in all, the oldest K792670 (1980). No later device cites it as a predicate yet.
- Root · 8 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 7 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 6 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 5 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 4 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 3 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 2 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 1 generation backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- This deviceK141004 Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −7 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −6 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −5 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −4 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −3 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −2 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −1 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| 0 (this device) | K141004 | Intraosseous Fixation System | Orthohelix Surgical Designs, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 3 | 0 |
| 2014 | 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 HTY? 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 HTY device
- #1 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K120165 | Intraosseous Fixation SystemSummary page 4…al Equivalence: The Intraosseous Fixation System is substantially equivalent to the OrthoHelix Intraosseous Fixation System (K120165), MMI Smart Toe (K070598), OrthoHelix MaxLock Extreme Extremity Plating System… | 2012 |
| * | K070598 | Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseSummary page 4…s substantially equivalent to the OrthoHelix Intraosseous Fixation System (K120165), MMI Smart Toe (K070598), OrthoHelix MaxLock Extreme Extremity Plating System with Variable Angle Technology (K100618)… | 2007 |
| * | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle TechnologySummary page 4…Toe (K070598), OrthoHelix MaxLock Extreme Extremity Plating System with Variable Angle Technology (K100618), Extremity Medical HammerFiX IP Fusion System (K133636), Bioretec ActivaPin (K061164)… | 2010 |
| * | K133636 | Extremity Medical Hammertoe DeviceSummary page 4…ting System with Variable Angle Technology (K100618), Extremity Medical HammerFiX IP Fusion System (K133636), Bioretec ActivaPin (K061164) and Arthrex Bio‐Pin (K050259). Mechanical 4 point bend, axial p… | 2014 |
| * | K061164 | ActivapinSummary page 4…with Variable Angle Technology (K100618), Extremity Medical HammerFiX IP Fusion System (K133636), Bioretec ActivaPin (K061164) and Arthrex Bio‐Pin (K050259). Mechanical 4 point bend, axial pull‐… | 2006 |
| * | K050259 | Arthrex Bio-PinSummary page 4…ity Medical HammerFiX IP Fusion System (K133636), Bioretec ActivaPin (K061164) and Arthrex Bio‐Pin (K050259). Mechanical 4 point bend, axial pull‐ out, insertion and removal torque and torque to failure… | 2005 |
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 18 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 7 of the 55 ancestors have a recall of any class.
- 3 other devices also cite its predicate K120165.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · HTY
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HTY
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTY
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTY
39in 2025
MAUDE reports naming product code HTY, 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 | 6 | 112 | 0 | 46 |
| 2008 | 6 | 86 | 0 | 38 |
| 2009 | 2 | — | 1 | 36 |
| 2010 | 9 | 180 | 1 | 33 |
| 2011 | 6 | 82 | 0 | 164 |
| 2012 | 4 | 76 | 0 | 129 |
| 2013 | 4 | 128 | 0 | 187 |
| 2014 | 8 | 73 | 0 | 149 |
| 2015 | 8 | 101 | 0 | 121 |
| 2016 | 6 | 114 | 2 | 128 |
| 2017 | 5 | 127 | 0 | 82 |
| 2018 | 4 | 162 | 0 | 138 |
| 2019 | 4 | 93 | 1 | 222 |
| 2020 | 5 | 108 | 0 | 210 |
| 2021 | 5 | 137 | 0 | 148 |
| 2022 | 4 | 121 | 2 | 96 |
| 2023 | 5 | 146 | 0 | 153 |
| 2024 | 1 | — | 0 | 297 |
| 2025 | 5 | 90 | 0 | 39 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Intraosseous Fixation System is indicated to stabilize and aid in fixation of fractures, fusions, and osteotomies of the phalanges.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141004 · printed Nov 5, 2026
Cite this page
510(k) Report. “K141004: Intraosseous Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K141004
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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