510(k) · Cleared
ClearedSyntec Non-Sterile Steinmann Pins System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syntec Scientific Corporation · JDW Pin, Fixation, Threaded
Cleared on May 5, 2020 as substantially equivalent to K983121 (Syntec Scientific Corp., 1998) after a 28-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- May 5, 2020
- Review
- 28 days
- Class
- Class II
- Product code
- JDW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983121 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK983121 Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S…Syntec Scientific Corp. · 1998
- This deviceK200933 Syntec Non-Sterile Steinmann Pins SystemSyntec Scientific Corporation · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983121 | Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S 290-101/160… | Syntec Scientific Corp. | 1998 | — |
| 0 (this device) | K200933 | Syntec Non-Sterile Steinmann Pins System | Syntec Scientific Corporation | 2020 | — |
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 |
|---|---|---|---|
| * | K983121 | Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S 290-101/160, 290-201/216…Summary page 4…Class II Modified devices: Non-Sterile Kirschner Wires and Steinmann Pins (K983121) Prior Submission: None Syntec, Taipei-Taiwan… | 1998 |
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?
- Its one ancestor has no recall.
- 6 other devices also cite its predicate K983121.
How does its category compare?
All JDW devicesJDW Pin, Fixation, Threaded: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 provided non-sterile. The devices are indicated for use in fracture fixation, for healing of facile bone fragments, for osteotomies in the presence of adequate immobilization, as guide pins for insertion of other implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200933 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200933: Syntec Non-Sterile Steinmann Pins System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200933
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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