510(k) · Cleared
Recalled · 2011Fischer Wire/Pin Clamp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Buckman Co., Inc. · HXK Holder, Needle; Orthopedic
Cleared on Feb 7, 1986 after a 35-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it. It has been recalled once.
- Decided
- Feb 7, 1986
- Review
- 35 days
- Class
- Class I
- Product code
- HXK
- Recalls
- 1
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK860018 Fischer Wire/Pin ClampBuckman Co., Inc. · 1986
- Descendant · cites it directly · 5 of its ownK083789 Ace Fischer External Fixation SystemDePuy Orthopaedics, Inc. · 2009
- Descendant · 2 generations on · 2 of its ownK190486 Pitkar External Fixation SystemS.H.Pitkar Orthotools Pvt., Ltd. · 2019
- Descendant · 3 generations on · 1 of its ownK202833 Sequel External Fixation DeviceSequel Medical, Inc. · 2021
- Descendant · 4 generations on · 0 of its ownK253291 Excelsior SystemBlue Ocean Global · 2026
- Descendant · 2 generations on · 0 of its ownK111993 FramewalkerQuantum Medical Concepts, LLC · 2011
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K083789Ace Fischer External Fixation SystemDePuy Orthopaedics, Inc. · 2009 · cites it directly5descendants
- K190486Pitkar External Fixation SystemS.H.Pitkar Orthotools Pvt., Ltd. · 2019 · 2 generations on2descendants
- K202833Sequel External Fixation DeviceSequel Medical, Inc. · 2021 · 3 generations on1descendant
- K253291Excelsior SystemBlue Ocean Global · 2026 · 4 generations on0descendants
- K111993FramewalkerQuantum Medical Concepts, LLC · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K860018 | Fischer Wire/Pin Clamp | Buckman Co., Inc. | 1986 | — |
| +1 | K083789 | Ace Fischer External Fixation System | DePuy Orthopaedics, Inc. | 2009 | — |
| +2 | K190486 | Pitkar External Fixation System | S.H.Pitkar Orthotools Pvt., Ltd. | 2019 | — |
| +3 | K202833 | Sequel External Fixation Device | Sequel Medical, Inc. | 2021 | — |
| +4 | K253291 | Excelsior System | Blue Ocean Global | 2026 | — |
| +2 | K111993 | Framewalker | Quantum Medical Concepts, LLC | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 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 HXK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083789 | Ace Fischer External Fixation System | 2009 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 8, 2011 | Not classified | Z-0508-2012 | Component change control | DePuy has received three complaints concerning oversized bolt threads in the Offset Wire Fixation Bolts used in the Ace- Fischer External Fixation System. This could lead to the inability to properly thread the nut onto the bolt. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K083789 (DePuy Orthopaedics, Inc., 2009) has gone furthest, with 5 descendants of its own.
How does its category compare?
All HXK devicesHXK Holder, Needle; Orthopedic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HXK
FDA has decided no HXK device since 2007.
Median 510(k) review, days · HXK
Too few HXK 510(k)s in any year since 2007 to give a median.
Recalls per year · HXK
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HXK
7in 2025
MAUDE reports naming product code HXK, 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 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 1 | 4 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 0 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 0 | — | 1 | 5 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K860018 · printed Nov 5, 2026
Cite this page
510(k) Report. “K860018: Fischer Wire/Pin Clamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K860018
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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