510(k) · Cleared
ClearedReprocessed Ebi External Fixation Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alliance Medical Corp. · KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Cleared on Jun 24, 2002 as substantially equivalent to K010437 (Ebi, L.P., 2001) and 3 other predicates after a 315-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Jun 24, 2002
- Review
- 315 days
- Class
- Class II
- Product code
- KTW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K951357 (1995). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK951357 Ebi Small External Fixator (S/E/F/)Electro-Biology, Inc. · 1995
- This deviceK012645 Reprocessed Ebi External Fixation DevicesAlliance Medical Corp. · 2002
- Descendant · cites it directly · 0 of its ownK052064 Alliance Medical Corporation Reprocessed External Fixation DevicesAlliance Medical Corp. · 2005
Most influential descendants
Showing 1 of 1 · See all- K052064Alliance Medical Corporation Reprocessed External Fixation DevicesAlliance Medical Corp. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951357 | Ebi Small External Fixator (S/E/F/) | Electro-Biology, Inc. | 1995 | — |
| 0 (this device) | K012645 | Reprocessed Ebi External Fixation Devices | Alliance Medical Corp. | 2002 | — |
| +1 | K052064 | Alliance Medical Corporation Reprocessed External Fixation Devices | Alliance Medical Corp. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 KTW? 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? (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 |
|---|---|---|---|
| * | K010437 | Modification to Ebi Xfix DFS Rail System | 2001 |
| * | K951357 | Ebi Small External Fixator (S/E/F/)Summary page 1…EBI ROO096 EXTERNAL FIXATOR Predicate device(s): KO10437 EBI XFIXB DFSO Rail System K951357 E31 Small External Fixator K953406 EBI X Fix DynaFix System… | 1995 |
| * | K953406 | Ebi X Fix Dynafix System (DFS)Summary page 1…KO10437 EBI XFIXB DFSO Rail System K951357 E31 Small External Fixator K953406 EBI X Fix DynaFix System K970290 EBI X Fix DynaFix Mini External Fixator === Pa… | 1995 |
| * | K970290 | Ebi X Fix Dynafix Mini External Fixation SystemSummary page 1…K951357 E31 Small External Fixator K953406 EBI X Fix DynaFix System K970290 EBI X Fix DynaFix Mini External Fixator Device description: External fixation devices are speci… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052064 | Alliance Medical Corporation Reprocessed External Fixation Devices | 2005 | 0 |
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?
How does its category compare?
All KTW devicesKTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KTW
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · KTW
Too few KTW 510(k)s in any year since 2007 to give a median.
Recalls per year · KTW
57in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTW
96in 2025
MAUDE reports naming product code KTW, 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 | 3 |
| 2008 | 2 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 57 | 26 |
| 2011 | 0 | — | 0 | 21 |
| 2012 | 1 | — | 0 | 70 |
| 2013 | 0 | — | 0 | 70 |
| 2014 | 0 | — | 0 | 62 |
| 2015 | 0 | — | 0 | 26 |
| 2016 | 1 | — | 0 | 41 |
| 2017 | 2 | — | 0 | 27 |
| 2018 | 0 | — | 0 | 24 |
| 2019 | 1 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 60 |
| 2021 | 0 | — | 0 | 25 |
| 2022 | 0 | — | 0 | 50 |
| 2023 | 0 | — | 0 | 30 |
| 2024 | 0 | — | 0 | 123 |
| 2025 | 0 | — | 0 | 96 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Reprocessed external fixation devices are indicated for use in patients requiring external skeletal fixation oand treatment of fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K012645 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012645: Reprocessed Ebi External Fixation Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012645
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026