510(k) · Cleared
ClearedEbi Xfix DFS Wristfix System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ebi, L.P. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Nov 19, 1999 as substantially equivalent to K951357 (Electro-Biology, Inc., 1995) and 1 other predicate after a 21-day review. Its family tree reaches back 1 generation to 1995. 3 later devices descend from it.
- Decided
- Nov 19, 1999
- Review
- 21 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K951357 (1995). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK951357 Ebi Small External Fixator (S/E/F/)Electro-Biology, Inc. · 1995
- This deviceK993649 Ebi Xfix DFS Wristfix SystemEbi, L.P. · 1999
- Descendant · cites it directly · 1 of its ownK012062 PF2Fixano SA · 2001
- Descendant · 2 generations on · 0 of its ownK022771 Twin FixFixano SA · 2002
- Descendant · cites it directly · 0 of its ownK020311 Clearview Wrist FixatorRigid FX Orthopedics, Incorporated · 2002
Most influential descendants
Showing 3 of 3 · See allView 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) | K993649 | Ebi Xfix DFS Wristfix System | Ebi, L.P. | 1999 | — |
| +1 | K012062 | PF2 | Fixano SA | 2001 | — |
| +2 | K022771 | Twin Fix | Fixano SA | 2002 | — |
| +1 | K020311 | Clearview Wrist Fixator | Rigid FX Orthopedics, Incorporated | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 2 | 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 KTT? 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 KTT device
- #1 K242861 TrueLok Elevatescore 21.4 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K951357 | Ebi Small External Fixator (S/E/F/)Summary page 1…ccessories, 21 CFR 888.3030. 3. Predicate or legally marketed devices that are substantially equivalent: « EBI XFIX DFS Small External Fixator — Electro-Biology, Inc. (K951357) » Synthes Distal Radius Fixator — Synthes USA (K963618) 4. Description of the device: The EBI XFIX DFS Wristfix System has not… | 1995 |
| * | K963618 | Synthes Simple Small External Fixator (Ssef)Summary page 1…keted devices that are substantially equivalent: « EBI XFIX DFS Small External Fixator — Electro-Biology, Inc. (K951357) » Synthes Distal Radius Fixator — Synthes USA (K963618) 4. Description of the device: The EBI XFIX DFS Wristfix System has not changed the Indications for Use or fundamental scientifi… | 1996 |
What descends from it? (3)
2 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?
How does its category compare?
All KTT devicesKTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KTT
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KTT
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KTT
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTT
673in 2025
MAUDE reports naming product code KTT, 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 | 9 | 55 | 2 | 45 |
| 2008 | 11 | 73 | 1 | 66 |
| 2009 | 11 | 94 | 2 | 45 |
| 2010 | 12 | 148 | 1 | 121 |
| 2011 | 10 | 157 | 0 | 196 |
| 2012 | 9 | 140 | 4 | 527 |
| 2013 | 7 | 87 | 7 | 898 |
| 2014 | 14 | 129 | 0 | 445 |
| 2015 | 12 | 60 | 0 | 401 |
| 2016 | 10 | 142 | 0 | 400 |
| 2017 | 11 | 184 | 1 | 485 |
| 2018 | 6 | 149 | 14 | 597 |
| 2019 | 8 | 110 | 3 | 800 |
| 2020 | 9 | 200 | 0 | 942 |
| 2021 | 10 | 83 | 2 | 961 |
| 2022 | 3 | 25 | 0 | 627 |
| 2023 | 7 | 29 | 0 | 554 |
| 2024 | 5 | 90 | 0 | 523 |
| 2025 | 10 | 88 | 0 | 673 |
| 2026 | 5 | 68 | 11 | — |
What is it indicated for?
The EBI XFIX DFS Wristfix System is intended for use in upper extremity applications
for the reduction, alignment and stabilization of intra-articular and extra-articular
fractures, corrective osteotomies, and soft tissue deformities.
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/K993649 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993649: Ebi Xfix DFS Wristfix System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993649
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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