510(k) · Cleared
ClearedFramewalker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantum Medical Concepts, LLC · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Oct 24, 2011 as substantially equivalent to K043289 (Signal Medical Corp., 2005) and 1 other predicate after a 103-day review. Its family tree reaches back 2 generations to 1980.
- Decided
- Oct 24, 2011
- Review
- 103 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K801594 (1980). 6 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K801594 | Ace Fischer External Fixation Device | Ace Orthopedic Manufacturing Co. | 1980 | — |
| −1 | K083789 | Ace Fischer External Fixation System | DePuy Orthopaedics, Inc. | 2009 | — |
| 0 (this device) | K111993 | Framewalker | Quantum Medical Concepts, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1996 | 1 | 0 |
| 2005 | 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? (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 |
|---|---|---|---|
| * | K043289 | E-Z Frame External Surgical Support BootSummary page 1…hich Substantial Equivalence Is Claimed: The FrameWalker has an identical use and is substantially equivalent to the sole portion of the E-Z Frame External Support Boot, K04328 9 and the Ace Fischer External Fixation System, K083789. Ref. surgical technique supplied in apperidix "B" pg. 15,P/N 880-04-015 'E… | 2005 |
| * | K083789 | Ace Fischer External Fixation SystemSummary page 1…r has an identical use and is substantially equivalent to the sole portion of the E-Z Frame External Support Boot, K04328 9 and the Ace Fischer External Fixation System, K083789. Ref. surgical technique supplied in apperidix "B" pg. 15,P/N 880-04-015 'Elevator Attachment'. Device Description: Framewalk… | 2009 |
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 31 years and passes through 3 companies; a new generation was cleared every 28.5 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 1 other device also cites its predicate K043289.
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. 2011, 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?
This device is indicated for use in patients who are undergoing external ring fixation of the Foot and Ankle for the following conditions:
For use in the treatment of fracture fixation (open and closed), pseudarthrosis or nonunions of long bones, limb lengthening by distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111993 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111993: Framewalker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111993
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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