510(k) · Cleared
Recalled · Class II · 2014Modification to:Sbi Ringfix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Small Bone Innovations, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Jun 29, 2007 as substantially equivalent to K890814 (Danek Medical, Inc., 1989) after a 39-day review. Its family tree reaches back 1 generation to 1989. 9 later devices descend from it. It has been recalled once.
- Decided
- Jun 29, 2007
- Review
- 39 days
- Class
- Class II
- Product code
- KTT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K890814 (1989). 9 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK890814 Danek Ring Fixator (DRF)Danek Medical, Inc. · 1989
- This deviceK071394 Modification to:Sbi RingfixSmall Bone Innovations, Inc. · 2007
- Descendant · cites it directly · 5 of its ownK093057 Biomet Vision Footring SystemEbi, L.P. · 2009
- Descendant · 2 generations on · 3 of its ownK140463 Integra External Fixation SystemAscension Orthopedic · 2014 · Recalled
- Descendant · cites it directly · 1 of its ownK202833 Sequel External Fixation DeviceSequel Medical, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK181630 Revolution External Plating SystemNew Standard Device Dba Metalogix · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK253291 Excelsior SystemBlue Ocean Global · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K093057Biomet Vision Footring SystemEbi, L.P. · 2009 · cites it directly5descendants
- K140463Integra External Fixation SystemAscension Orthopedic · 2014 · 2 generations on3descendants
- K202833Sequel External Fixation DeviceSequel Medical, Inc. · 2021 · cites it directly1descendant
- K181630Revolution External Plating SystemNew Standard Device Dba Metalogix · 2019 · cites it directly1descendant
- K253291Excelsior SystemBlue Ocean Global · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890814 | Danek Ring Fixator (DRF) | Danek Medical, Inc. | 1989 | — |
| 0 (this device) | K071394 | Modification to:Sbi Ringfix | Small Bone Innovations, Inc. | 2007 | — |
| +1 | K093057 | Biomet Vision Footring System | Ebi, L.P. | 2009 | — |
| +2 | K140463 | Integra External Fixation System | Ascension Orthopedic | 2014 | 3 |
| +1 | K202833 | Sequel External Fixation Device | Sequel Medical, Inc. | 2021 | — |
| +1 | K181630 | Revolution External Plating System | New Standard Device Dba Metalogix | 2019 | 5 |
| +2 | K253291 | Excelsior System | Blue Ocean Global | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 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? (1)
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 |
|---|---|---|---|
| * | K890814 | Danek Ring Fixator (DRF)Summary page 1…fic technology as that of the currently available RingFIXTM System (originally cleared as the Danek Ring Fixator in K890814). The Design Control Activities Summary demonstrates that the the modified… | 1989 |
What descends from it? (9)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 7, 2014 | Class II | Z-1720-2014 | Packaging process control | Small Bone Innovations (SBI) is recalling non-sterile RingFIX Olive Wires labeled as item #451-3004 Drill tip 1.8 mm diameter 400mm olive k-wire packaged with item #451-3005 Bayonet tip 1.8mm diameter 400mm olive k-wire inside. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K093057 (Ebi, L.P., 2009) has gone furthest, with 5 descendants of its own.
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. 2007, this device’s year, is highlighted.
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 RingFIXTM System is intended for:
1. fracture fixation (open and closed)
2. pseudarthrosis or nonunions of long bones
3. limb lengthening by epiphyseal or metaphyseal distraction
4. correction of bony or soft tissue deformities
5. correction of segmental bony or soft tissue defects
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071394 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071394: Modification to:Sbi Ringfix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071394
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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