510(k) · Cleared
ClearedAap K-Wire, Steinmann Pin, Cerclage Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aap Implantate AG · JDW Pin, Fixation, Threaded
Cleared on Oct 17, 2013 as substantially equivalent to K030665 (Stork Instrumente GmbH, 2003) and 1 other predicate after a 150-day review. Its family tree reaches back 3 generations to 1996. 12 later devices descend from it.
- Decided
- Oct 17, 2013
- Review
- 150 days
- Class
- Class II
- Product code
- JDW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K961522 (1996). 4 ancestors in all. 12 later devices descend from it, 4 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 deviceK131459 Aap K-Wire, Steinmann Pin, Cerclage WireAap Implantate AG · 2013
- Descendant · cites it directly · 6 of its ownK171715 HammerTube SystemParagon 28 · 2018 · Recalled
- Descendant · 2 generations on · 1 of its ownK231231 MR Safety and Compatibility Testing and Labeling for Paragon 28…Paragon 28, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK192768 Temporary Fixation PinsEisertech, LLC · 2019
- Descendant · cites it directly · 1 of its ownK182171 SMV Scientific K-Wire and PinsSummit Medventures · 2018
- Descendant · 2 generations on · 0 of its ownK262722 Primal K-Wire (P99-193-1410)Paragon 28, Inc. · 2026
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K171715HammerTube SystemParagon 28 · 2018 · cites it directly6descendants
- K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc. · 2023 · 2 generations on1descendant
- K192768Temporary Fixation PinsEisertech, LLC · 2019 · cites it directly1descendant
- K182171SMV Scientific K-Wire and PinsSummit Medventures · 2018 · cites it directly1descendant
- K262722Primal K-Wire (P99-193-1410)Paragon 28, Inc. · 2026 · 2 generations on0descendants
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) | K131459 | Aap K-Wire, Steinmann Pin, Cerclage Wire | Aap Implantate AG | 2013 | — |
| +1 | K171715 | HammerTube System | Paragon 28 | 2018 | 1 |
| +2 | K231231 | MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic… | Paragon 28, Inc. | 2023 | — |
| +1 | K192768 | Temporary Fixation Pins | Eisertech, LLC | 2019 | — |
| +1 | K182171 | SMV Scientific K-Wire and Pins | Summit Medventures | 2018 | — |
| +2 | K262722 | Primal K-Wire (P99-193-1410) | Paragon 28, Inc. | 2026 | — |
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 |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 JDW? 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 JDW device
- #1 K260073 XT3 System; XT3 System, Mini; XT3 System…score 15.0 · 15 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 1…opedics/871 HTY: Pin, Fixation Smooth Predicate device: Bone Wire from Stbrk Instrumente GmbH, Germany under the premarket notification K030665 (Mar 25, 2003) and Kirsch ner / Guide Wires from SMT Schilling Metailtech nik… | 2003 |
| * | K100736 | Kirschner and Guide WiresSummary page 1…, 2003) and Kirsch ner / Guide Wires from SMT Schilling Metailtech nik GmbH, Germany under the premarket notification K100736 (Sep 10, 2010) Device Description: The aap Wire Bone Portfolio consists of K-Wires, Steinmann… | 2010 |
What descends from it? (12)
See all 124 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 4 companies; a new generation was cleared every 6.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K171715 (Paragon 28, 2018) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K030665.
How does its category compare?
All JDW devicesJDW Pin, Fixation, Threaded: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · JDW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDW
Too few JDW 510(k)s in any year since 2007 to give a median.
Recalls per year · JDW
21in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDW
29in 2025
MAUDE reports naming product code JDW, 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 | 2 | — | 0 | 25 |
| 2008 | 0 | — | 0 | 26 |
| 2009 | 1 | — | 2 | 29 |
| 2010 | 2 | — | 2 | 29 |
| 2011 | 1 | — | 0 | 55 |
| 2012 | 1 | — | 52 | 75 |
| 2013 | 2 | — | 0 | 69 |
| 2014 | 2 | — | 0 | 27 |
| 2015 | 1 | — | 0 | 70 |
| 2016 | 0 | — | 0 | 46 |
| 2017 | 1 | — | 2 | 43 |
| 2018 | 1 | — | 21 | 94 |
| 2019 | 1 | — | 0 | 575 |
| 2020 | 2 | — | 0 | 402 |
| 2021 | 2 | — | 0 | 168 |
| 2022 | 2 | — | 0 | 121 |
| 2023 | 0 | — | 0 | 72 |
| 2024 | 0 | — | 0 | 65 |
| 2025 | 2 | — | 0 | 29 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Wire devices (K-Wire, Cerciage Wires, Steinmann Pins)
* guide wire for osteosynthesis implants
* accessories for external fixation (Steinmann Pin)
* application as implant according to the AO/ASIF principles of fracture management
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131459 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131459: Aap K-Wire, Steinmann Pin, Cerclage Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131459
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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