510(k) · Cleared
ClearedHoffmann II External Fixation System
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 Sep 8, 1995 as substantially equivalent to K803166 (Howmedica Corp., 1981) and 1 other predicate after an 85-day review. Its family tree reaches back 1 generation to 1981. 6 later devices descend from it.
- Decided
- Sep 8, 1995
- Review
- 85 days
- Class
- Class II
- Product code
- JEC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K803166 (1981). 2 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK803166 Double Ball JointHowmedica Corp. · 1981
- This deviceK952730 Hoffmann II External Fixation SystemHowmedica Corp. · 1995
- Descendant · cites it directly · 2 of its ownK110965 Renovis T 710 Large External Fixation SystemRenovis Surgical Technologies, LLC · 2011
- Descendant · cites it directly · 2 of its ownK032427 Fep Fixation System and Stylo Wrist Fixation SystemMeridan Medical · 2003
- Descendant · 2 generations on · 0 of its ownK213905 ONX Large External Fixation SystemOrthonovis, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK171211 OIC External Fixation SystemOrthopaedic Implant Company · 2017
- Descendant · 2 generations on · 0 of its ownK070016 Blue SharkMeridan Medical · 2007
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K110965Renovis T 710 Large External Fixation SystemRenovis Surgical Technologies, LLC · 2011 · cites it directly2descendants
- K032427Fep Fixation System and Stylo Wrist Fixation SystemMeridan Medical · 2003 · cites it directly2descendants
- K213905ONX Large External Fixation SystemOrthonovis, Inc. · 2022 · 2 generations on0descendants
- K171211OIC External Fixation SystemOrthopaedic Implant Company · 2017 · cites it directly0descendants
- K070016Blue SharkMeridan Medical · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K803166 | Double Ball Joint | Howmedica Corp. | 1981 | — |
| 0 (this device) | K952730 | Hoffmann II External Fixation System | Howmedica Corp. | 1995 | — |
| +1 | K110965 | Renovis T 710 Large External Fixation System | Renovis Surgical Technologies, LLC | 2011 | — |
| +1 | K032427 | Fep Fixation System and Stylo Wrist Fixation System | Meridan Medical | 2003 | — |
| +2 | K213905 | ONX Large External Fixation System | Orthonovis, Inc. | 2022 | — |
| +1 | K171211 | OIC External Fixation System | Orthopaedic Implant Company | 2017 | — |
| +2 | K070016 | Blue Shark | Meridan Medical | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 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? (4)
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 |
|---|---|---|---|
| * | K803166 | Double Ball JointSummary page 1…stem Components including the 5- Hole Ball Joint, 8x8 Articulating Coupling and 8x5 Articulating Coupling (Preamendment); Hoffmann® 5-Hole Lightweight Alloy Ball Joint ((K803166); Hex Fix™ External Fixation System (K841334); and Synthes External Fixator (Synthes). All of these devices are intended to be u… | 1981 |
| * | K841334 | Richards Fixator SystemSummary page 1…int, 8x8 Articulating Coupling and 8x5 Articulating Coupling (Preamendment); Hoffmann® 5-Hole Lightweight Alloy Ball Joint ((K803166); Hex Fix™ External Fixation System (K841334); and Synthes External Fixator (Synthes). All of these devices are intended to be used in an external fixation frame to stabiliz… | 1984 |
| * | — | Original Hoffmann® External Fixation System Components including the 5-Hole Ball Joint… Named without a submission number | |
| * | — | Synthes External Fixator Named without a submission number | |
| † | K861766 | Howmedica Hoffmann Fixation Pin System | 1986 |
What descends from it? (6)
3 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K110965 (Renovis Surgical Technologies, LLC, 2011) has gone furthest, with 2 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 | — |
What is it indicated for?
These components are intended to be used in conjunction with Half Pins or Transfixing Pins of the Hoffmann® External Fixation System (reference K861766) for the stabilization of fractures of the tibia, femur, humerus, radius or pelvis.
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/K952730 · printed Nov 4, 2026
Cite this page
510(k) Report. “K952730: Hoffmann II External Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952730
Report an extraction error
Are you the manufacturer?
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