510(k) · Cleared
ClearedBiomet Vision Footring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Jul 9, 2007 as substantially equivalent to K052239 (Ebi, L.P., 2005) and 2 other predicates after a 49-day review. Its family tree reaches back 2 generations to 1983. 1 later device descends from it.
- Decided
- Jul 9, 2007
- Review
- 49 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K831576 (1983). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK831576 OrthofixElectro-Biology, Inc. · 1983
- 1 generation backK955848 Orthofix ModulsystemOrthofix, Inc. · 1996 · Recalled
- This deviceK071395 Biomet Vision Footring SystemBiomet Manufacturing Corp · 2007
- Descendant · cites it directly · 0 of its ownK093753 Mdpo Frame SystemMdpo, LLC · 2010
Most influential descendants
Showing 1 of 1 · See all- 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 | K831576 | Orthofix | Electro-Biology, Inc. | 1983 | — |
| −1 | K955848 | Orthofix Modulsystem | Orthofix, Inc. | 1996 | 23 |
| 0 (this device) | K071395 | Biomet Vision Footring System | Biomet Manufacturing Corp | 2007 | — |
| +1 | K093753 | Mdpo Frame System | Mdpo, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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? (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 |
|---|---|---|---|
| * | K052239 | Ebi Dynafix Vision Footplate SystemSummary page 1…and accessories, 21 CFR 888.3030, KTT Legally Marketed Devices To Which Substantial Equivalence Is Claimed: EBI® DynaFix® Vision® FootPlate System, K052239 (Biomet Trauma), Sheffield Ring Fixator, K944092, K955848 and/or subsequent (Orthofix, Inc.) Device Description: The Biomet® Vis… | 2005 |
| * | K944092 | Additional Accessories for the Orthofix SystemSummary page 1…3030, KTT Legally Marketed Devices To Which Substantial Equivalence Is Claimed: EBI® DynaFix® Vision® FootPlate System, K052239 (Biomet Trauma), Sheffield Ring Fixator, K944092, K955848 and/or subsequent (Orthofix, Inc.) Device Description: The Biomet® Vision® FootRing System isan external fixation devic… | 1995 |
| * | K955848 | Orthofix ModulsystemSummary page 1…Legally Marketed Devices To Which Substantial Equivalence Is Claimed: EBI® DynaFix® Vision® FootPlate System, K052239 (Biomet Trauma), Sheffield Ring Fixator, K944092, K955848 and/or subsequent (Orthofix, Inc.) Device Description: The Biomet® Vision® FootRing System isan external fixation device. The de… | 1996 |
| * | — | Biomet® Vision® FootRing System Named without a submission number |
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 |
|---|---|---|---|
| K093753 | Mdpo Frame System | 2010 | 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?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 12.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K093753 (Mdpo, LLC, 2010) has gone furthest, with 0 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 Biomet® Vision® FootRing System is intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by the use of the external fixation treatment modality.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071395 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071395: 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/K071395
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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