510(k) · Cleared
ClearedSidekick Circular Fixator System: Struts and Hinges
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Jun 10, 2010 as substantially equivalent to K052005 (R&R Medical, Inc., 2005) after a 142-day review. Its family tree reaches back 2 generations to 1994. 6 later devices descend from it.
- Decided
- Jun 10, 2010
- Review
- 142 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K941048 (1994). 4 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK941048 True/Lok Monolateral/Bilateral FixatorApplied Osteo Systems, Inc. · 1994 · Recalled
- 1 generation backK052005 R&R External Fixation SystemR&R Medical, Inc. · 2005
- This deviceK100137 Sidekick Circular Fixator System: Struts and HingesWrightmedicaltechnologyinc · 2010
- Descendant · cites it directly · 4 of its ownK153635 SALVATION (R) External Fixation SystemWrightmedicaltechnologyinc · 2016
- Descendant · 2 generations on · 3 of its ownK162033 SALVATION External Fixation SystemWright Medical · 2017
- Descendant · 3 generations on · 1 of its ownK180832 SALVATION External Fixation SystemWrightmedicaltechnologyinc · 2018
- Descendant · 4 generations on · 0 of its ownK200343 FusionFrame Ring Lock SystemGlw Medical Innovation · 2020
- Descendant · 3 generations on · 0 of its ownK173883 External Fixation SystemLife Spine, Inc. · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K153635SALVATION (R) External Fixation SystemWrightmedicaltechnologyinc · 2016 · cites it directly4descendants
- K162033SALVATION External Fixation SystemWright Medical · 2017 · 2 generations on3descendants
- K180832SALVATION External Fixation SystemWrightmedicaltechnologyinc · 2018 · 3 generations on1descendant
- K200343FusionFrame Ring Lock SystemGlw Medical Innovation · 2020 · 4 generations on0descendants
- K173883External Fixation SystemLife Spine, Inc. · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K941048 | True/Lok Monolateral/Bilateral Fixator | Applied Osteo Systems, Inc. | 1994 | 1 |
| −1 | K052005 | R&R External Fixation System | R&R Medical, Inc. | 2005 | — |
| 0 (this device) | K100137 | Sidekick Circular Fixator System: Struts and Hinges | Wrightmedicaltechnologyinc | 2010 | — |
| +1 | K153635 | SALVATION (R) External Fixation System | Wrightmedicaltechnologyinc | 2016 | — |
| +2 | K162033 | SALVATION External Fixation System | Wright Medical | 2017 | — |
| +3 | K180832 | SALVATION External Fixation System | Wrightmedicaltechnologyinc | 2018 | — |
| +4 | K200343 | FusionFrame Ring Lock System | Glw Medical Innovation | 2020 | — |
| +3 | K173883 | External Fixation System | Life Spine, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K052005 | R&R External Fixation SystemSummary page 1…section 888.3030 Device Product Code & Panel: Orthopedics/87/KTT A.3. Predicate Device: R & R External Fixation (Ring Fixator) (K052005) A.4. Device Description The SIDEKICK® Circular Fixator System: Struts and Hinges is a dynamic frame that can change po… | 2005 |
What descends from it? (6)
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 16 years and passes through 3 companies; a new generation was cleared every 10.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K153635 (Wrightmedicaltechnologyinc, 2016) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K052005.
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?
The SIDEKICK® Circular Fixator System: Struts and Hinges and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction or bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects. The SIDEKICK® Circular Fixator System: Struts and Hinges is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100137 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100137: Sidekick Circular Fixator System: Struts and Hinges.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100137
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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