510(k) · Cleared
ClearedMemometal Implants (K-Snap & TI-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 Nov 3, 2010 as substantially equivalent to K100736 (Smt Schilling Metalltechnik GmbH, 2010) and 1 other predicate after a 103-day review. Its family tree reaches back 3 generations to 1996. 1 later device descends from it.
- Decided
- Nov 3, 2010
- Review
- 103 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K961522 (1996). 7 ancestors in all, the oldest K960385 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK961522 Kirschner Wire (K-Wire) and Steinmann PinSynvasive Technology, Inc. · 1996
- 2 generations backK030665 Bone WireStork Instrumente GmbH · 2003
- 1 generation backK100736 Kirschner and Guide WiresSmt Schilling Metalltechnik GmbH · 2010
- This deviceK102072 Memometal Implants (K-Snap & TI-Fuse)Memometal Technologies · 2010
- Descendant · cites it directly · 0 of its ownK143049 LYNC intramedullary implantNovastep · 2015
Most influential descendants
Showing 1 of 1 · See all- K143049LYNC intramedullary implantNovastep · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K961522 | Kirschner Wire (K-Wire) and Steinmann Pin | Synvasive Technology, Inc. | 1996 | — |
| −2 | K030665 | Bone Wire | Stork Instrumente GmbH | 2003 | — |
| −1 | K100736 | Kirschner and Guide Wires | Smt Schilling Metalltechnik GmbH | 2010 | — |
| 0 (this device) | K102072 | Memometal Implants (K-Snap & TI-Fuse) | Memometal Technologies | 2010 | — |
| +1 | K143049 | LYNC intramedullary implant | Novastep | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (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 |
|---|---|---|---|
| * | K100736 | Kirschner and Guide Wires Cleared while this submission was under review Summary page 1…mon Name MEMOMETAL implants ICassifcation Name Smooth or threade metallc boe fstener Product code HTY Legally marketed K100736 SMT Schilling Metalltechnik GMBH Kirschner and predicate devices Guide wire K022599 Newdeal… | 2010 |
| * | K022599 | Newdeal K WireSummary page 1…HTY Legally marketed K100736 SMT Schilling Metalltechnik GMBH Kirschner and predicate devices Guide wire K022599 Newdeal K-Wire Description MEMOMETAL implants are singeus oe fixation appliance… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| 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 14 years and passes through 4 companies; a new generation was cleared every 6.5 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K143049 (Novastep, 2015) has gone furthest, with 0 descendants of its own.
- 11 other devices also cite its predicate K100736.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 implants (K-Snap® & Ti-Fuse®) are indicated for fixation of bone fracture, for bone reconstruction or arthrodesis in presence of appropriate immobilization. The size of the implant should be adapted to the specific indication.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102072 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102072: Memometal Implants (K-Snap & TI-Fuse).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102072
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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