510(k) · Cleared
ClearedSteinmann Pins and Kirschner Wires
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker GmbH · JDW Pin, Fixation, Threaded
Cleared on Oct 5, 2021 as substantially equivalent to K001886 (Howmedica Osteonics Corp., 2000) and 1 other predicate after a 144-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Oct 5, 2021
- Review
- 144 days
- Class
- Class II
- Product code
- JDW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K971962 (1997). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK971962 Osteo Kirschner WiresOsteonics Corp. · 1997
- This deviceK211508 Steinmann Pins and Kirschner WiresStryker GmbH · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971962 | Osteo Kirschner Wires | Osteonics Corp. | 1997 | — |
| 0 (this device) | K211508 | Steinmann Pins and Kirschner Wires | Stryker GmbH | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 |
|---|---|---|---|
| * | K001886 | Apex Fixation PinsSummary page 5…and T45 HX08 Phone: +00 353 87 7995645 Date: August 09, 2021 Primary Predicate Device Apex Fixation Pins (K001886) Additional Predicate Device Osteo Kirschner Wires (K971962) Device Description: The Steinmann Pins and Kirschne… | 2000 |
| * | K971962 | Osteo Kirschner WiresSummary page 5…5645 Date: August 09, 2021 Primary Predicate Device Apex Fixation Pins (K001886) Additional Predicate Device Osteo Kirschner Wires (K971962) Device Description: The Steinmann Pins and Kirschner Wires are designed for multiple purposes… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All JDW devicesJDW Pin, Fixation, Threaded: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
The Steinmann Pins are intended to be used in conjunction with a compatible Stryker external supporting frame for stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation. The Kirschner Wires are intended for use in skeletal traction for alignment and reduction of long bone fractures, and as guide wires in hip pinning…
Read the full statement (144 words)
The Steinmann Pins are intended to be used in conjunction with a compatible Stryker external supporting frame for
stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.
The Kirschner Wires are intended for use in skeletal traction for alignment and reduction of long bone fractures, and as guide wires in hip pinning, and as fracture fixation devices in certain other small bone fractures.
* For use as guide wires in hip pinning procedures,
* For use in aligning and reducing long bone fractures,
» For use in securing temporary stabilization of bone fractures such as olecranon fractures; patella fractures; tibia plateau fractures; hand and foot bone fractures; humeral, radial and ulnar fractures.
» For use with cerclage wire/cable in treating greater trochanter fractures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211508 · printed Nov 3, 2026
Cite this page
510(k) Report. “K211508: Steinmann Pins and Kirschner Wires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K211508
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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