510(k) · Cleared
ClearedFusion Medical Ring Lock System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
John J Riccio · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on May 27, 2010 as substantially equivalent to K052196 (Vilex, Inc., 2005) after a 62-day review. Its family tree reaches back 3 generations to 1983. 1 later device descends from it.
- Decided
- May 27, 2010
- Review
- 62 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K831576 (1983). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK831576 OrthofixElectro-Biology, Inc. · 1983
- 2 generations backK955848 Orthofix ModulsystemOrthofix, Inc. · 1996 · Recalled
- 1 generation backK052196 Vilex X-FixVilex, Inc. · 2005
- This deviceK100857 Fusion Medical Ring Lock SystemJohn J Riccio · 2010
- Descendant · cites it directly · 0 of its ownK200343 FusionFrame Ring Lock SystemGlw Medical Innovation · 2020
Most influential descendants
Showing 1 of 1 · See all- K200343FusionFrame Ring Lock SystemGlw Medical Innovation · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K831576 | Orthofix | Electro-Biology, Inc. | 1983 | — |
| −2 | K955848 | Orthofix Modulsystem | Orthofix, Inc. | 1996 | 23 |
| −1 | K052196 | Vilex X-Fix | Vilex, Inc. | 2005 | — |
| 0 (this device) | K100857 | Fusion Medical Ring Lock System | John J Riccio | 2010 | — |
| +1 | K200343 | FusionFrame Ring Lock System | Glw Medical Innovation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 21.3 · 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 |
|---|---|---|---|
| * | K052196 | Vilex X-FixSummary page 1…KIT, CRF-21I 888.3030 Device class: 1I Classification panel: Orthopedics Predicate devices: K052 196 Vilex Common Name: External Ring Fixation Device Trade Name:… | 2005 |
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 |
|---|---|---|---|
| K200343 | FusionFrame Ring Lock System | 2020 | 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 27 years and passes through 4 companies; a new generation was cleared every 9.7 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K200343 (Glw Medical Innovation, 2020) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K052196.
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. 2010, 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?
Stabilization of fractures & Osteotomy Bone deformity correction of lower extremities Arthrodesis of the rear foot, mid foot, and ankle joint. Limb lengthening in pediatric and adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100857 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100857: Fusion Medical Ring Lock System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100857
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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