510(k) · Cleared
ClearedHowmedica Hoffmann Fixation Pin System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Corp. · JDW Pin, Fixation, Threaded
Cleared on Jul 8, 1986 after a 62-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 140 later devices descend from it.
- Decided
- Jul 8, 1986
- Review
- 62 days
- Class
- Class II
- Product code
- JDW
- Recalls
- None
- Predicates
- 0
140 later devices descend from it, 4 citing it directly.
- This deviceK861766 Howmedica Hoffmann Fixation Pin SystemHowmedica Corp. · 1986
- Descendant · cites it directly · 133 of its ownK964094 MinifixFerguson Medical · 1996
- Descendant · 2 generations on · 120 of its ownK061253 Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2006
- Descendant · 3 generations on · 91 of its ownK070756 Smith and Nephew Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 46 of its ownK092386 R3 Multi-Hole Shells and 36MM Xlpe Acetabular LinersSmith & Nephew, Inc. · 2009
- Descendant · 3 generations on · 35 of its ownK100933 Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc. · 2010
Showing 5 of 140 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 140 · See all- K964094MinifixFerguson Medical · 1996 · cites it directly133descendants
- K061253Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2006 · 2 generations on120descendants
- K070756Smith and Nephew Reflection 3 Acetabular SystemSmith & Nephew, Inc. · 2007 · 3 generations on91descendants
- K092386R3 Multi-Hole Shells and 36MM Xlpe Acetabular LinersSmith & Nephew, Inc. · 2009 · 3 generations on46descendants
- K100933Consensus CS2 Plus Acetabular InsertConsensus Orthopedics, Inc. · 2010 · 3 generations on35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K861766 | Howmedica Hoffmann Fixation Pin System | Howmedica Corp. | 1986 | — |
| +1 | K964094 | Minifix | Ferguson Medical | 1996 | — |
| +2 | K061253 | Reflection 3 Acetabular System | Smith & Nephew, Inc. | 2006 | — |
| +3 | K070756 | Smith and Nephew Reflection 3 Acetabular System | Smith & Nephew, Inc. | 2007 | 6 |
| +3 | K092386 | R3 Multi-Hole Shells and 36MM Xlpe Acetabular Liners | Smith & Nephew, Inc. | 2009 | — |
| +3 | K100933 | Consensus CS2 Plus Acetabular Insert | Consensus Orthopedics, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 7 | 0 |
| 2011 | 9 | 0 |
| 2012 | 10 | 0 |
| 2013 | 8 | 0 |
| 2014 | 8 | 0 |
| 2015 | 7 | 0 |
| 2016 | 4 | 0 |
| 2017 | 13 | 0 |
| 2018 | 8 | 0 |
| 2019 | 7 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 11 | 0 |
| 2023 | 8 | 0 |
| 2024 | 6 | 0 |
| 2025 | 10 | 0 |
| 2026 | 10 | 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? (140)
See all 1404 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, K964094 (Ferguson Medical, 1996) has gone furthest, with 133 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/K861766 · printed Nov 6, 2026
Cite this page
510(k) Report. “K861766: Howmedica Hoffmann Fixation Pin System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K861766
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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