510(k) · Cleared
ClearedAce/Fisher Percutaneous Transfixing Pins
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Buckman Co., Inc. · JDW Pin, Fixation, Threaded
Cleared on Jan 14, 1988 after a 41-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jan 14, 1988
- Review
- 41 days
- Class
- Class II
- Product code
- JDW
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK875022 Ace/Fisher Percutaneous Transfixing PinsBuckman Co., Inc. · 1988
- Descendant · cites it directly · 2 of its ownK021933 Tempfix External Fixation SystemDePuy Orthopaedics, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK052918 Reprocessed External Fixation DevicesAlliance Medical Corp. · 2006
- Descendant · 2 generations on · 0 of its ownK043113 Tempfix External Fixation System, MR SafeDePuy Orthopaedics, Inc. · 2005
Most influential descendants
Showing 3 of 3 · See all- K021933Tempfix External Fixation SystemDePuy Orthopaedics, Inc. · 2002 · cites it directly2descendants
- K052918Reprocessed External Fixation DevicesAlliance Medical Corp. · 2006 · cites it directly0descendants
- K043113Tempfix External Fixation System, MR SafeDePuy Orthopaedics, Inc. · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K875022 | Ace/Fisher Percutaneous Transfixing Pins | Buckman Co., Inc. | 1988 | — |
| +1 | K021933 | Tempfix External Fixation System | DePuy Orthopaedics, Inc. | 2002 | — |
| +1 | K052918 | Reprocessed External Fixation Devices | Alliance Medical Corp. | 2006 | — |
| +2 | K043113 | Tempfix External Fixation System, MR Safe | DePuy Orthopaedics, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
2 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?
- Of its descendants, K021933 (DePuy Orthopaedics, Inc., 2002) has gone furthest, with 2 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 | — |
https://510kreport.com/device/K875022 · printed Nov 4, 2026
Cite this page
510(k) Report. “K875022: Ace/Fisher Percutaneous Transfixing Pins.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K875022
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026