510(k) · Cleared
ClearedTemporary Fixation Pins
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eisertech, LLC · JDW Pin, Fixation, Threaded
Cleared on Dec 26, 2019 as substantially equivalent to K131459 (Aap Implantate AG, 2013) after an 87-day review. Its family tree reaches back 4 generations to 1996. 1 later device descends from it.
- Decided
- Dec 26, 2019
- Review
- 87 days
- Class
- Class II
- Product code
- JDW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K961522 (1996). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK961522 Kirschner Wire (K-Wire) and Steinmann PinSynvasive Technology, Inc. · 1996
- 3 generations backK030665 Bone WireStork Instrumente GmbH · 2003
- 2 generations backK100736 Kirschner and Guide WiresSmt Schilling Metalltechnik GmbH · 2010
- 1 generation backK131459 Aap K-Wire, Steinmann Pin, Cerclage WireAap Implantate AG · 2013
- This deviceK192768 Temporary Fixation PinsEisertech, LLC · 2019
- Descendant · cites it directly · 0 of its ownK231905 Electro-Spec Steri-CapsElectro-Spec, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K231905Electro-Spec Steri-CapsElectro-Spec, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K961522 | Kirschner Wire (K-Wire) and Steinmann Pin | Synvasive Technology, Inc. | 1996 | — |
| −3 | K030665 | Bone Wire | Stork Instrumente GmbH | 2003 | — |
| −2 | K100736 | Kirschner and Guide Wires | Smt Schilling Metalltechnik GmbH | 2010 | — |
| −1 | K131459 | Aap K-Wire, Steinmann Pin, Cerclage Wire | Aap Implantate AG | 2013 | — |
| 0 (this device) | K192768 | Temporary Fixation Pins | Eisertech, LLC | 2019 | — |
| +1 | K231905 | Electro-Spec Steri-Caps | Electro-Spec, Inc. | 2023 | — |
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 |
|---|---|---|
| 2023 | 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? (1)
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 |
|---|---|---|---|
| * | K131459 | Aap K-Wire, Steinmann Pin, Cerclage WireSummary page 4…87- Orthopedic Product Code: JDW, HTY Primary aap Implantate AG aap Wire Bone / K-Wire; Cerciage Wire, Predicate Device: Steinmann Pin (K131459) Reference Predicate Device: Eisertech, LLC Cervical Plate System Instruments (K190565) Device Description: The Eisertech,… | 2013 |
| † | K190565 | Cervical Plate | 2019 |
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 |
|---|---|---|---|
| K231905 | Electro-Spec Steri-Caps | 2023 | 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 23 years and passes through 5 companies; a new generation was cleared every 6.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K231905 (Electro-Spec, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K131459.
How does its category compare?
All JDW devicesJDW Pin, Fixation, Threaded: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Eisertech, LLC Temporary Fixation Pins are indicated for the following:
- guide wire for osteosynthesis implants
- accessories for external fixation (Steinmann Pin)
- application as implant according to the principles of fracture management
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192768 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192768: Temporary Fixation Pins.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192768
Report an extraction error
Are you the manufacturer?
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