510(k) · Cleared
ClearedFusionFrame Ring Lock System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Glw Medical Innovation · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Sep 14, 2020 as substantially equivalent to K100857 (John J Riccio, 2010) and 2 other predicates after a 216-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Sep 14, 2020
- Review
- 216 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K941048 (1994). 17 ancestors in all, the oldest K831576 (1983). No later device cites it as a predicate yet.
- Root · 6 generations backK941048 True/Lok Monolateral/Bilateral FixatorApplied Osteo Systems, Inc. · 1994 · Recalled
- 5 generations backK052005 R&R External Fixation SystemR&R Medical, Inc. · 2005
- 4 generations backK100137 Sidekick Circular Fixator System: Struts and HingesWrightmedicaltechnologyinc · 2010
- 3 generations backK153635 SALVATION (R) External Fixation SystemWrightmedicaltechnologyinc · 2016
- 2 generations backK162033 SALVATION External Fixation SystemWright Medical · 2017
- 1 generation backK180832 SALVATION External Fixation SystemWrightmedicaltechnologyinc · 2018
- This deviceK200343 FusionFrame Ring Lock SystemGlw Medical Innovation · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K941048 | True/Lok Monolateral/Bilateral Fixator | Applied Osteo Systems, Inc. | 1994 | 1 |
| −5 | K052005 | R&R External Fixation System | R&R Medical, Inc. | 2005 | — |
| −4 | K100137 | Sidekick Circular Fixator System: Struts and Hinges | Wrightmedicaltechnologyinc | 2010 | — |
| −3 | K153635 | SALVATION (R) External Fixation System | Wrightmedicaltechnologyinc | 2016 | — |
| −2 | K162033 | SALVATION External Fixation System | Wright Medical | 2017 | — |
| −1 | K180832 | SALVATION External Fixation System | Wrightmedicaltechnologyinc | 2018 | — |
| 0 (this device) | K200343 | FusionFrame Ring Lock System | Glw Medical Innovation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2005 | 3 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 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? (3)
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 |
|---|---|---|---|
| * | K100857 | Fusion Medical Ring Lock SystemSummary page 4…nd Accessories PREDICATE DEVICES: Primary Predicate: FUSION MEDICAL RING LOCK SYSTEM (K100857) Secondary Predicates: SALVATION External Fixation System (K… | 2010 |
| * | K180832 | SALVATION External Fixation SystemSummary page 4…(K100857) Secondary Predicates: SALVATION External Fixation System (K180832) ILIZAROV EXTERNAL FIXATION SYSTEM (K962808)… | 2018 |
| * | K962808 | Ilizarov External Fixation SystemSummary page 4…SALVATION External Fixation System (K180832) ILIZAROV EXTERNAL FIXATION SYSTEM (K962808) K200343 - Page 2 of 4 Device Descripti… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 5 companies; a new generation was cleared every 4.8 years on median.
- 2 of the 17 ancestors have a recall of any class.
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. 2020, 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 FusionFrame Ring Lock System is indicated for:
• Stabilization of fractures and osteotomies;
• Bone deformity correction of lower extremities;
• Arthrodesis of the rear foot, mid foot and ankle joint; and
• Limb Lengthening in pediatric and adult patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200343 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200343: FusionFrame 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/K200343
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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