510(k) · Cleared
ClearedDouble Ball Joint
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Corp. · JEC Component, Traction, Invasive
Cleared on Jan 9, 1981 after a 25-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Jan 9, 1981
- Review
- 25 days
- Class
- Class II
- Product code
- JEC
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK803166 Double Ball JointHowmedica Corp. · 1981
- Descendant · cites it directly · 6 of its ownK952730 Hoffmann II External Fixation SystemHowmedica Corp. · 1995
- Descendant · 2 generations on · 2 of its ownK110965 Renovis T 710 Large External Fixation SystemRenovis Surgical Technologies, LLC · 2011
- Descendant · 2 generations on · 2 of its ownK032427 Fep Fixation System and Stylo Wrist Fixation SystemMeridan Medical · 2003
- Descendant · 3 generations on · 0 of its ownK213905 ONX Large External Fixation SystemOrthonovis, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK171211 OIC External Fixation SystemOrthopaedic Implant Company · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K952730Hoffmann II External Fixation SystemHowmedica Corp. · 1995 · cites it directly6descendants
- K110965Renovis T 710 Large External Fixation SystemRenovis Surgical Technologies, LLC · 2011 · 2 generations on2descendants
- K032427Fep Fixation System and Stylo Wrist Fixation SystemMeridan Medical · 2003 · 2 generations on2descendants
- K213905ONX Large External Fixation SystemOrthonovis, Inc. · 2022 · 3 generations on0descendants
- K171211OIC External Fixation SystemOrthopaedic Implant Company · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K803166 | Double Ball Joint | Howmedica Corp. | 1981 | — |
| +1 | K952730 | Hoffmann II External Fixation System | Howmedica Corp. | 1995 | — |
| +2 | K110965 | Renovis T 710 Large External Fixation System | Renovis Surgical Technologies, LLC | 2011 | — |
| +2 | K032427 | Fep Fixation System and Stylo Wrist Fixation System | Meridan Medical | 2003 | — |
| +3 | K213905 | ONX Large External Fixation System | Orthonovis, Inc. | 2022 | — |
| +2 | K171211 | OIC External Fixation System | Orthopaedic Implant Company | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 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 JEC? 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 JEC device
- #1 K193256 Anjon Bremer Halo Systemscore 3.2 · 2 generations · no Class I recall
- #2 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? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K952730 | Hoffmann II External Fixation System | 1995 | 6 |
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, K952730 (Howmedica Corp., 1995) has gone furthest, with 6 descendants of its own.
How does its category compare?
All JEC devicesJEC Component, Traction, Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JEC
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · JEC
Too few JEC 510(k)s in any year since 2007 to give a median.
Recalls per year · JEC
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEC
2in 2025
MAUDE reports naming product code JEC, 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 | 1 | — | 0 | 1 |
| 2008 | 1 | — | 1 | 9 |
| 2009 | 1 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 1 | — | 0 | 15 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 1 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 1 | 8 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 2 | — | 1 | 2 |
| 2019 | 1 | — | 1 | 3 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 26 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K803166 · printed Nov 6, 2026
Cite this page
510(k) Report. “K803166: Double Ball Joint.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K803166
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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