510(k) · Cleared
Recalled · Class II · 2019Salvation 3DI Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · HRS Plate, Fixation, Bone
Cleared on May 22, 2014 as substantially equivalent to K061808 (Darco International, Inc., 2006) and 4 other predicates after a 52-day review. Its family tree reaches back 11 generations to 2001. 2 later devices descend from it. It has been recalled once.
- Decided
- May 22, 2014
- Review
- 52 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 11 generations to K010612 (2001). 143 ancestors in all, the oldest K792022 (1979). 2 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 7 generations between
- 3 generations backK092497 Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc. · 2009
- 2 generations backK100107 Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · Recalled
- 1 generation backK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011
- This deviceK140792 Salvation 3DI Plating SystemWrightmedicaltechnologyinc · 2014
- Descendant · cites it directly · 0 of its ownK233816 REDEMPTION Charcot Plating SystemVilex, LLC · 2024
- Descendant · cites it directly · 0 of its ownK210157 SOLE Medial Column Fusion PlateOrthofix Srl · 2021
Show all 11 generations
- Root · 11 generations backK010612 Vectorvision KneeBrainlab AG · 2001
- 10 generations backK021306 Vectorvision CT-Free KneeBrainlab AG · 2002
- 9 generations backK040368 Vectorvision Hip 3.0Brainlab AG · 2004
- 8 generations backK052213 Navigation SW Hip 3.1 on CIBrainlab AG · 2005
- 7 generations backK060468 Vectorvision HipBrainlab AG · 2006
- 6 generations backK070731 Pigalileo Total Hip Replacement (THR) SystemPlus Orthopedics AG · 2007
- 5 generations backK080875 Pigalileo 4TH Generation SystemSmith & Nephew, Inc. · 2008
- 4 generations backK090420 Smith & Nephew Pigalileo Screw Targeting System V 1.0Smith & Nephew, Inc. · 2009
- 3 generations backK092497 Smith & Nephew Pigalileo Screw Targeting System, Version 1.1Smith & Nephew, Inc. · 2009
- 2 generations backK100107 Smith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. · 2010 · Recalled
- 1 generation backK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011
- This deviceK140792 Salvation 3DI Plating SystemWrightmedicaltechnologyinc · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K010612 | Vectorvision Knee | Brainlab AG | 2001 | — |
| −10 | K021306 | Vectorvision CT-Free Knee | Brainlab AG | 2002 | — |
| −9 | K040368 | Vectorvision Hip 3.0 | Brainlab AG | 2004 | — |
| −8 | K052213 | Navigation SW Hip 3.1 on CI | Brainlab AG | 2005 | — |
| −7 | K060468 | Vectorvision Hip | Brainlab AG | 2006 | — |
| −6 | K070731 | Pigalileo Total Hip Replacement (THR) System | Plus Orthopedics AG | 2007 | — |
| −5 | K080875 | Pigalileo 4TH Generation System | Smith & Nephew, Inc. | 2008 | — |
| −4 | K090420 | Smith & Nephew Pigalileo Screw Targeting System V 1.0 | Smith & Nephew, Inc. | 2009 | — |
| −3 | K092497 | Smith & Nephew Pigalileo Screw Targeting System, Version 1.1 | Smith & Nephew, Inc. | 2009 | — |
| −2 | K100107 | Smith & Nephew Sureshot Distal Targeting System V2.0 | Smith & Nephew, Inc. | 2010 | 1 |
| −1 | K110670 | VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone… | Smith & Nephew, Inc. | 2011 | — |
| 0 (this device) | K140792 | Salvation 3DI Plating System | Wrightmedicaltechnologyinc | 2014 | — |
| +1 | K233816 | REDEMPTION Charcot Plating System | Vilex, LLC | 2024 | — |
| +1 | K210157 | SOLE Medial Column Fusion Plate | Orthofix Srl | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 7 | 0 |
| 1997 | 2 | 0 |
| 1998 | 7 | 0 |
| 1999 | 5 | 0 |
| 2000 | 13 | 0 |
| 2001 | 14 | 0 |
| 2002 | 12 | 0 |
| 2003 | 6 | 0 |
| 2004 | 6 | 0 |
| 2005 | 9 | 0 |
| 2006 | 10 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 6 | 0 |
| 2010 | 6 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K061808 | Darco Locking Bone Plate SystemSummary page 1…appliances and accessories, Class 11 Device Product Code, Device Panel: H-RS, Orthopedic (a)(3). Predicate Devices: K061 808: DARCO® RPS Plates K121651: ORTH-OLOC® 3Di Recon… | 2006 |
| * | K121651 | Ortholoc 3DI Midfoot/Flatfoot SystemSummary page 1…, Device Panel: H-RS, Orthopedic (a)(3). Predicate Devices: K061 808: DARCO® RPS Plates K121651: ORTH-OLOC® 3Di Recon Midfoot Plating System… | 2012 |
| * | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSummary page 1…K121651: ORTH-OLOC® 3Di Recon Midfoot Plating System 1(090675,K1110670: Smith and Nephew VLP Foot Plating, Screw… | 2009 |
| * | K110670 | VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Summary page 1…K121651: ORTH-OLOC® 3Di Recon Midfoot Plating System 1(090675,K1110670: Smith and Nephew VLP Foot Plating, Screw… | 2011 |
| * | K131093 | Ortholoc (R) 3DI Ankle Plating System | 2013 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 28, 2019 | Class II | Z-2055-2019 | Employee error | Potential for tube leakage |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 33 of the 143 ancestors have a recall of any class.
- Of its descendants, K233816 (Vilex, LLC, 2024) has gone furthest, with 0 descendants of its own.
- 23 other devices also cite its predicate K061808.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The SALVATION 3Di Plating System is indicated for the treatment of fracture stabilization/fixation, revision procedures, osteotomies, and reconstruction/arthrodesis of small bones, as well as patients with osteopenic bone. Specific examples include: medial column fusion (talus, navicular, cuboid, first metatarsal) for neuropathic osteoarthropathy (Charcot).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140792 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140792: Salvation 3DI Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140792
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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