510(k) · Cleared
ClearedThreaded Fixation Pin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sgarlato Laboratories, Inc. · JDW Pin, Fixation, Threaded
Cleared on Oct 21, 1998 after a 62-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Oct 21, 1998
- Review
- 62 days
- Class
- Class II
- Product code
- JDW
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK982931 Threaded Fixation PinSgarlato Laboratories, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK011875 Modification to the Tac' PinNew Deal, S.A. · 2001
Most influential descendants
Showing 1 of 1 · See all- K011875Modification to the Tac' PinNew Deal, S.A. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982931 | Threaded Fixation Pin | Sgarlato Laboratories, Inc. | 1998 | — |
| +1 | K011875 | Modification to the Tac' Pin | New Deal, S.A. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | — | Orthopaedic Biosystems Limited Threaded Fixation Pin Named without a submission number | |
| * | — | Synthes Threaded Kirschner Wires Named without a submission number |
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 |
|---|---|---|---|
| K011875 | Modification to the Tac' Pin | 2001 | 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?
- Of its descendants, K011875 (New Deal, S.A., 2001) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JDW devicesJDW Pin, Fixation, Threaded: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Threaded Fixation Pin is intended for patients where one of their small bones has been osteomized or fractured and the and the fragments are of sufficient size to place a .062 diameter threaded k-wire across to stabilize the part.
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/K982931 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982931: Threaded Fixation Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982931
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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