510(k) · Cleared
ClearedBiomet Vision Footring 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 Dec 1, 2009 as substantially equivalent to K041706 (Howmedica Osteonics Corp., 2004) and 1 other predicate after a 62-day review. Its family tree reaches back 2 generations to 1989. 5 later devices descend from it.
- Decided
- Dec 1, 2009
- Review
- 62 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K890814 (1989). 3 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK890814 Danek Ring Fixator (DRF)Danek Medical, Inc. · 1989
- 1 generation backK071394 Modification to:Sbi RingfixSmall Bone Innovations, Inc. · 2007 · Recalled
- This deviceK093057 Biomet Vision Footring SystemEbi, L.P. · 2009
- Descendant · cites it directly · 3 of its ownK140463 Integra External Fixation SystemAscension Orthopedic · 2014 · Recalled
- Descendant · 2 generations on · 1 of its ownK181630 Revolution External Plating SystemNew Standard Device Dba Metalogix · 2019 · Recalled
- Descendant · 3 generations on · 0 of its ownK233025 Revolution External Plating SystemNew Standard Device Dba Metalogix · 2024
- Descendant · 2 generations on · 0 of its ownK160830 Integra External Fixation SystemAscension Orthopedics · 2016 · Recalled
- Descendant · cites it directly · 0 of its ownK093753 Mdpo Frame SystemMdpo, LLC · 2010
Most influential descendants
Showing 5 of 5 · See all- K140463Integra External Fixation SystemAscension Orthopedic · 2014 · cites it directly3descendants
- K181630Revolution External Plating SystemNew Standard Device Dba Metalogix · 2019 · 2 generations on1descendant
- K233025Revolution External Plating SystemNew Standard Device Dba Metalogix · 2024 · 3 generations on0descendants
- K160830Integra External Fixation SystemAscension Orthopedics · 2016 · 2 generations on0descendants
- K093753Mdpo Frame SystemMdpo, LLC · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K890814 | Danek Ring Fixator (DRF) | Danek Medical, Inc. | 1989 | — |
| −1 | K071394 | Modification to:Sbi Ringfix | Small Bone Innovations, Inc. | 2007 | 1 |
| 0 (this device) | K093057 | Biomet Vision Footring System | Ebi, L.P. | 2009 | — |
| +1 | K140463 | Integra External Fixation System | Ascension Orthopedic | 2014 | 3 |
| +2 | K181630 | Revolution External Plating System | New Standard Device Dba Metalogix | 2019 | 5 |
| +3 | K233025 | Revolution External Plating System | New Standard Device Dba Metalogix | 2024 | — |
| +2 | K160830 | Integra External Fixation System | Ascension Orthopedics | 2016 | 2 |
| +1 | K093753 | Mdpo Frame System | Mdpo, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K041706 | Hoffmann II Foot RingSummary page 2…et Vision FootRing System is substantially equivalent to other legally marketed devices, including the Stryker Hoffman II Foot Ring (cleared under premarket notification K04 1706), and the S13i RingFDXrm System (cleared under premarket notification K07 1394). Operational principles for the device arc uncha… | 2004 |
| * | K071394 | Modification to:Sbi RingfixSummary page 2…devices, including the Stryker Hoffman II Foot Ring (cleared under premarket notification K04 1706), and the S13i RingFDXrm System (cleared under premarket notification K07 1394). Operational principles for the device arc unchanged. S DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2007 |
What descends from it? (5)
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?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 18.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K140463 (Ascension Orthopedic, 2014) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K041706.
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. 2009, 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 Biomet® Visions Foot Ring System is intended for use in the treatment of bone conditions including leg lengthening, osteotomnies, artlhrodesis, fracture fixation, and other bone conditions amenable to treatment by the use of the external fixation treatment modality.
Additional indications include:
* Correction of deformity
* Revision procedures where othcr treatments or devices have been unsuccessful
* Bone reconstruction procedures
* Fusions and replantations of the foot
* Charcot foot reconstruction and Lisifane dislocations
* Ankle distraction (arthrodiastasis)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093057 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093057: Biomet Vision Footring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093057
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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