510(k) · Cleared
ClearedSALVATION External Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wright Medical · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Mar 6, 2017 as substantially equivalent to K043174 (R&R Medical, Inc., 2005) and 2 other predicates after a 227-day review. Its family tree reaches back 4 generations to 1994. 3 later devices descend from it.
- Decided
- Mar 6, 2017
- Review
- 227 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K941048 (1994). 10 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK941048 True/Lok Monolateral/Bilateral FixatorApplied Osteo Systems, Inc. · 1994 · Recalled
- 3 generations backK052005 R&R External Fixation SystemR&R Medical, Inc. · 2005
- 2 generations backK100137 Sidekick Circular Fixator System: Struts and HingesWrightmedicaltechnologyinc · 2010
- 1 generation backK153635 SALVATION (R) External Fixation SystemWrightmedicaltechnologyinc · 2016
- This deviceK162033 SALVATION External Fixation SystemWright Medical · 2017
- Descendant · cites it directly · 1 of its ownK180832 SALVATION External Fixation SystemWrightmedicaltechnologyinc · 2018
- Descendant · 2 generations on · 0 of its ownK200343 FusionFrame Ring Lock SystemGlw Medical Innovation · 2020
- Descendant · cites it directly · 0 of its ownK173883 External Fixation SystemLife Spine, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K941048 | True/Lok Monolateral/Bilateral Fixator | Applied Osteo Systems, Inc. | 1994 | 1 |
| −3 | K052005 | R&R External Fixation System | R&R Medical, Inc. | 2005 | — |
| −2 | K100137 | Sidekick Circular Fixator System: Struts and Hinges | Wrightmedicaltechnologyinc | 2010 | — |
| −1 | K153635 | SALVATION (R) External Fixation System | Wrightmedicaltechnologyinc | 2016 | — |
| 0 (this device) | K162033 | SALVATION External Fixation System | Wright Medical | 2017 | — |
| +1 | K180832 | SALVATION External Fixation System | Wrightmedicaltechnologyinc | 2018 | — |
| +2 | K200343 | FusionFrame Ring Lock System | Glw Medical Innovation | 2020 | — |
| +1 | 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 |
| 2005 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 21.4 · 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 |
|---|---|---|---|
| * | K043174 | Stealth Fusion System, Model RR 1000Summary page 5…21 CFR 888.3030 – Class II Device Product Code, Device Panel: KTT, Orthopedic (a)(3). Predicate Device: K043174: SIDEKICK® Rearfoot Fixator (formerly STEALTH Fusion)… | 2005 |
| * | K052005 | R&R External Fixation SystemSummary page 5…174: SIDEKICK® Rearfoot Fixator (formerly STEALTH Fusion) K052005: SIDEKICK® Circular Fixator (formerly R&R External Fixator System)… | 2005 |
| * | K153635 | SALVATION (R) External Fixation SystemSummary page 5…® Circular Fixator (formerly R&R External Fixator System) K153635: SALVATION® External Fixation System (a)(4). Device Description… | 2016 |
What descends from it? (3)
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 23 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K180832 (Wrightmedicaltechnologyinc, 2018) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K043174.
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. 2017, 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 SALVATION® External Fixation System is intended for: • Fusions of the foot including: o Triple arthrodesis o Isolated hindfoot arthrodesis o Midfoot arthrodesis o Joints involved include tibiotalar, subtalar, talonavicular, calcaneocuboid, pantalar, tibio-talocalcaneus, naviculocuneiform, metatarsal cuneiform (first, second, third – e.g. Lapidus, TMT), metatarsal cuboid • Treatment of fractures including: o Treatment of LisFranc fracture/dislocations…
Read the full statement (306 words)
The SALVATION® External Fixation System is intended for:
• Fusions of the foot including:
o Triple arthrodesis
o Isolated hindfoot arthrodesis
o Midfoot arthrodesis
o Joints involved include tibiotalar, subtalar, talonavicular, calcaneocuboid, pantalar, tibio-talocalcaneus, naviculocuneiform, metatarsal cuneiform (first, second, third – e.g. Lapidus, TMT), metatarsal cuboid
• Treatment of fractures including:
o Treatment of LisFranc fracture/dislocations in diabetic and Charcot neuropathy patient
o Fractures and/or comminuted fractures (open or closed) of the calcaneus, talus, cuboid, navicular, cuneiforms, and/or metatarsals (including Jones fractures), ankle, and distal tibia
o Additional fixation adjunct to internal fixation of the distal tibia, calcaneus, talus, navicular, cuboid, cuneiforms, and/or metatarsals in patients with significant comorbidities (i.e. diabetes) that may preclude use of isolated internal fixation
• Reconstruction of deformities including:
o Neuropathic deformities
o Charcot reconstruction with or without corrective osteotomies
o Diabetic Charcot Reconstruction
o Prevention and treatment of contracture of joints and tendons in equinus
• Treatment of infected unions, nonunions, or malunions
• Offloading and or immobilization of ulcers and/or wounds of the foot or ankle
• Stabilization associated with tendon or ligament surgeries. Tendon lengthening, repairs and transfers both deep and or superficial around the foot and ankle including posterior tibial, tibialis anterior, flexor digitorum longus, achilles, flexor hallucis longus, peroneus brevis, peroneus longus, extensor hallucis longus, extensor digitorum longus
• Tumor and neoplasm resection and reconstruction
• Stabilization associated with rotation flaps, free flaps, muscle flaps, advancement flaps, fasciocutaneous flap, split thickness skin grafting, biological graft alternatives
• Pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction osteogenesis including bone transport
• Correction of bony or soft tissue deformities
• Correction of segmental or nonsegmental bony or soft tissue defects
• Use on long bones including the tibia and fibula
• Use with or without IM nail in the ankle in Charcot patients
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162033 · printed Nov 4, 2026
Cite this page
510(k) Report. “K162033: SALVATION External Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K162033
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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