510(k) · Cleared
ClearedMemometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Memometal Technologies · HTY Pin, Fixation, Smooth
Cleared on Jul 26, 2007 as substantially equivalent to K022599 (New Deal, S.A., 2002) and 1 other predicate after a 146-day review. Its family tree reaches back 2 generations to 1996. 72 later devices descend from it.
- Decided
- Jul 26, 2007
- Review
- 146 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K960385 (1996). 4 ancestors in all. 72 later devices descend from it, 14 citing it directly.
- Root · 2 generations backK960385 Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 1996
- 1 generation backK022599 Newdeal K WireNew Deal, S.A. · 2002
- This deviceK070598 Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseMemometal Technologies · 2007
- Descendant · cites it directly · 35 of its ownK120165 Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc. · 2012
- Descendant · 2 generations on · 31 of its ownK133636 Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014
- Descendant · 2 generations on · 16 of its ownK141857 CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
- Descendant · cites it directly · 16 of its ownK110445 Flexfusion (TM) Fixation ImplantNextremity Solutions, LLC · 2011 · Recalled
- Descendant · 3 generations on · 15 of its ownK151270 CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC · 2015
Showing 5 of 72 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 72 · See all- K120165Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc. · 2012 · cites it directly35descendants
- K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014 · 2 generations on31descendants
- K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015 · 2 generations on16descendants
- K110445Flexfusion (TM) Fixation ImplantNextremity Solutions, LLC · 2011 · cites it directly16descendants
- K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC · 2015 · 3 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K960385 | Sterile Kirschner Wires and Steinmann Pins | Depuy, Inc. | 1996 | — |
| −1 | K022599 | Newdeal K Wire | New Deal, S.A. | 2002 | — |
| 0 (this device) | K070598 | Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse | Memometal Technologies | 2007 | — |
| +1 | K120165 | Intraosseous Fixation System | Orthohelix Surgical Designs, Inc. | 2012 | — |
| +2 | K133636 | Extremity Medical Hammertoe Device | Extremity Medical, LLC | 2014 | — |
| +2 | K141857 | CrossTie Intraosseous Fixation System | Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem | 2015 | — |
| +1 | K110445 | Flexfusion (TM) Fixation Implant | Nextremity Solutions, LLC | 2011 | 6 |
| +3 | K151270 | CrossTIE Intraosseous Fixation System | Crossroads Extremity Systems, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 11 | 0 |
| 2015 | 8 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 7 | 0 |
| 2020 | 5 | 0 |
| 2021 | 5 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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? (2)
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 |
|---|---|---|---|
| * | K022599 | Newdeal K WireSummary page 1…AS`TENER ClssfiatonN-ame S~mco~~o~th rhrea-ded m-etali boefsee _ Legally marketed K022599i5 NEW-DEALK-Wir-e predicate devices K964226 MEMORY STAPLE (LANDOS - DEPUY Inc) Descrito MFE-MOMiE-TAL… | 2002 |
| * | K964226 | Memory Staple (20 Sizes Available)Summary page 1…rhrea-ded m-etali boefsee _ Legally marketed K022599i5 NEW-DEALK-Wir-e predicate devices K964226 MEMORY STAPLE (LANDOS - DEPUY Inc) Descrito MFE-MOMiE-TAL I--NTfRAkMEDULA-RY… | 1997 |
What descends from it? (72)
See all 7214 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120165 | Intraosseous Fixation System | 2012 | 35 |
| K110445 | Flexfusion (TM) Fixation Implant | 2011 | 16 |
| K133477 | Toegrip, Implant for Proximal Inter-Phalangeal Arthrodesis | 2014 | 9 |
| K131640 | Smooth or Threaded Metallic Bone Fastener | 2013 | 7 |
| K112197 | Memometal Intra-Medullary Bone Fastener | 2011 | 5 |
| K170326 | dynaMX Intramedullary Implant | 2017 | 2 |
| K172485 | Footmotion HammerToe | 2018 | 0 |
| K173616 | DIP Arthrodesis System | 2018 | 0 |
| K150211 | EzFuze Implant System | 2015 | 0 |
| K143049 | LYNC intramedullary implant | 2015 | 0 |
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 11 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K120165 (Orthohelix Surgical Designs, Inc., 2012) has gone furthest, with 35 descendants of its own.
- 22 other devices also cite its predicate K022599.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 MEMOMETAL INTRA MEDULLARY BONE FASTENER (SMART TOE / X-FUSE) are indicated for small bone reconstruction limited to inter-digital fusion of fingers and toes and small bones fusion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070598 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070598: Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070598
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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