510(k) · Cleared
ClearedR&R External Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
R&R Medical, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Sep 6, 2005 as substantially equivalent to K941048 (Applied Osteo Systems, Inc., 1994) and 2 other predicates after a 43-day review. Its family tree reaches back 1 generation to 1994. 11 later devices descend from it.
- Decided
- Sep 6, 2005
- Review
- 43 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K941048 (1994). 3 ancestors in all. 11 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK941048 True/Lok Monolateral/Bilateral FixatorApplied Osteo Systems, Inc. · 1994 · Recalled
- This deviceK052005 R&R External Fixation SystemR&R Medical, Inc. · 2005
- Descendant · cites it directly · 6 of its ownK100137 Sidekick Circular Fixator System: Struts and HingesWrightmedicaltechnologyinc · 2010
- Descendant · cites it directly · 4 of its ownK153635 SALVATION (R) External Fixation SystemWrightmedicaltechnologyinc · 2016
- Descendant · cites it directly · 3 of its ownK162033 SALVATION External Fixation SystemWright Medical · 2017
- Descendant · cites it directly · 2 of its ownK113106 Dne External Fixation SystemDne, LLC · 2012
- Descendant · cites it directly · 1 of its ownK180832 SALVATION External Fixation SystemWrightmedicaltechnologyinc · 2018
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K100137Sidekick Circular Fixator System: Struts and HingesWrightmedicaltechnologyinc · 2010 · cites it directly6descendants
- K153635SALVATION (R) External Fixation SystemWrightmedicaltechnologyinc · 2016 · cites it directly4descendants
- K162033SALVATION External Fixation SystemWright Medical · 2017 · cites it directly3descendants
- K113106Dne External Fixation SystemDne, LLC · 2012 · cites it directly2descendants
- K180832SALVATION External Fixation SystemWrightmedicaltechnologyinc · 2018 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941048 | True/Lok Monolateral/Bilateral Fixator | Applied Osteo Systems, Inc. | 1994 | 1 |
| 0 (this device) | K052005 | R&R External Fixation System | R&R Medical, Inc. | 2005 | — |
| +1 | K100137 | Sidekick Circular Fixator System: Struts and Hinges | Wrightmedicaltechnologyinc | 2010 | — |
| +1 | K153635 | SALVATION (R) External Fixation System | Wrightmedicaltechnologyinc | 2016 | — |
| +1 | K162033 | SALVATION External Fixation System | Wright Medical | 2017 | — |
| +1 | K113106 | Dne External Fixation System | Dne, LLC | 2012 | — |
| +1 | K180832 | SALVATION External Fixation System | Wrightmedicaltechnologyinc | 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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K941048 | True/Lok Monolateral/Bilateral FixatorSummary page 1…Class II per 21 CFR section 888.3030 Product Code KTT Equivalent Device True/Lok Monolateral/Bilaterial (Applied Osteo Systems, K941048) DFS® MiniFixator (EBI, K951357/K970290) Small Bone External Fixation System (A… | 1994 |
| * | K951357 | Ebi Small External Fixator (S/E/F/)Summary page 1…Product Code KTT Equivalent Device True/Lok Monolateral/Bilaterial (Applied Osteo Systems, K941048) DFS® MiniFixator (EBI, K951357/K970290) Small Bone External Fixation System (Acumned) Device Description The R&R Ring Fixator assembly… | 1995 |
| * | K970290 | Ebi X Fix Dynafix Mini External Fixation SystemSummary page 1…t Code KTT Equivalent Device True/Lok Monolateral/Bilaterial (Applied Osteo Systems, K941048) DFS® MiniFixator (EBI, K951357/K970290) Small Bone External Fixation System (Acumned) Device Description The R&R Ring Fixator assembly consist… | 1997 |
| * | — | Small Bone External Fixation System Named without a submission number |
What descends from it? (11)
See all 116 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100137 | Sidekick Circular Fixator System: Struts and Hinges | 2010 | 6 |
| K153635 | SALVATION (R) External Fixation System | 2016 | 4 |
| K162033 | SALVATION External Fixation System | 2017 | 3 |
| K113106 | Dne External Fixation System | 2012 | 2 |
| K180832 | SALVATION External Fixation System | 2018 | 1 |
| K140158 | S.E.a.L. Fracture Fusion Tube | 2014 | 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?
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.
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 R&R Ring Fixator 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 R&R Ring Fixator is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.
The R&R Unilateral Fixator is indicated for stabilizing various fractures including open and/or comminuted fractures, infected non-unions, fractures with length discrepancies, fusions and corrective osteotomies of the metacarpal, metatarsal, ulnar, and calcaneal bones.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052005 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052005: R&R External Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052005
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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