510(k) · Cleared
ClearedKirschner and Guide Wires
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smt Schilling Metalltechnik GmbH · HTY Pin, Fixation, Smooth
Cleared on Sep 10, 2010 as substantially equivalent to K030665 (Stork Instrumente GmbH, 2003) and 1 other predicate after a 179-day review. Its family tree reaches back 2 generations to 1996. 65 later devices descend from it.
- Decided
- Sep 10, 2010
- Review
- 179 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K961522 (1996). 3 ancestors in all. 65 later devices descend from it, 12 citing it directly.
- Root · 2 generations backK961522 Kirschner Wire (K-Wire) and Steinmann PinSynvasive Technology, Inc. · 1996
- 1 generation backK030665 Bone WireStork Instrumente GmbH · 2003
- This deviceK100736 Kirschner and Guide WiresSmt Schilling Metalltechnik GmbH · 2010
- Descendant · cites it directly · 24 of its ownK121277 Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire…Z-Medical GmbH & Co. KG · 2012
- Descendant · 2 generations on · 15 of its ownK131061 Restore Bunion Correction SystemNextremity Solutions · 2013
- Descendant · cites it directly · 12 of its ownK131459 Aap K-Wire, Steinmann Pin, Cerclage WireAap Implantate AG · 2013
- Descendant · cites it directly · 12 of its ownK120787 Merete Locking Bone Plate System IiiMerete Medical GmbH · 2012
- Descendant · 2 generations on · 10 of its ownK133691 Extrimilock Ankle Plating SystemOsteomed LP · 2014
Showing 5 of 65 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 65 · See all- K121277Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-StapleZ-Medical GmbH & Co. KG · 2012 · cites it directly24descendants
- K131061Restore Bunion Correction SystemNextremity Solutions · 2013 · 2 generations on15descendants
- K131459Aap K-Wire, Steinmann Pin, Cerclage WireAap Implantate AG · 2013 · cites it directly12descendants
- K120787Merete Locking Bone Plate System IiiMerete Medical GmbH · 2012 · cites it directly12descendants
- K133691Extrimilock Ankle Plating SystemOsteomed LP · 2014 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961522 | Kirschner Wire (K-Wire) and Steinmann Pin | Synvasive Technology, Inc. | 1996 | — |
| −1 | K030665 | Bone Wire | Stork Instrumente GmbH | 2003 | — |
| 0 (this device) | K100736 | Kirschner and Guide Wires | Smt Schilling Metalltechnik GmbH | 2010 | — |
| +1 | K121277 | Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-Staple | Z-Medical GmbH & Co. KG | 2012 | — |
| +2 | K131061 | Restore Bunion Correction System | Nextremity Solutions | 2013 | — |
| +1 | K131459 | Aap K-Wire, Steinmann Pin, Cerclage Wire | Aap Implantate AG | 2013 | — |
| +1 | K120787 | Merete Locking Bone Plate System Iii | Merete Medical GmbH | 2012 | — |
| +2 | K133691 | Extrimilock Ankle Plating System | Osteomed LP | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 6 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 5 | 0 |
| 2023 | 9 | 0 |
| 2024 | 8 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K030665 | Bone WireSummary page 2…ion pins and wires are substantial equivalent based upon design, dimensional and mate- rials characterization to the Stdrk Kirschner Wires (K-Wires) and Steinmann Pins (#K030665) of Stork Instrumente GmbH, 78576 Emmingen-Liptingen, Germany and Teleflex KMedic Internal/External Fixation Devices (#K070561) o… | 2003 |
| * | K070561 | Kmedic Internal/External Fixation DevicesSummary page 2…chner Wires (K-Wires) and Steinmann Pins (#K030665) of Stork Instrumente GmbH, 78576 Emmingen-Liptingen, Germany and Teleflex KMedic Internal/External Fixation Devices (#K070561) of Teleflex Medical, Bannockburn, IL. 4. Description of the Device Orthopaedic fixation pins and wires are metal pins for use… | 2007 |
What descends from it? (65)
See all 6512 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121277 | Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-Staple | 2012 | 24 |
| K131459 | Aap K-Wire, Steinmann Pin, Cerclage Wire | 2013 | 12 |
| K120787 | Merete Locking Bone Plate System Iii | 2012 | 12 |
| K180348 | Field Orthopaedics Micro Screw System | 2018 | 3 |
| K131264 | Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and Screws | 2013 | 1 |
| K102072 | Memometal Implants (K-Snap & TI-Fuse) | 2010 | 1 |
| K231339 | Tyber Medical Pin and Wire System (various) | 2023 | 0 |
| K213982 | Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires | 2022 | 0 |
| K203811 | GPC Intraheal Intramedullary Nailing System | 2022 | 0 |
| K191424 | Interphalangeal Joint Fusion Device Range | 2019 | 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 3 companies; a new generation was cleared every 7.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K121277 (Z-Medical GmbH & Co. KG, 2012) has gone furthest, with 24 descendants of its own.
- 2 other devices also cite its predicate K030665.
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?
Orthopaedic fixation pins and wires are intended to perform as fixation and stabilization unit of bone fractures or as guidance at insertion of implants into the skeletal system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100736 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100736: Kirschner and Guide Wires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100736
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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