510(k) · Cleared
ClearedSalvation Osteopenic Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · HWC Screw, Fixation, Bone
Cleared on May 14, 2014 as substantially equivalent to K110670 (Smith & Nephew, Inc., 2011) and 1 other predicate after an 85-day review. Its family tree reaches back 11 generations to 2001. 1 later device descends from it.
- Decided
- May 14, 2014
- Review
- 85 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K010612 (2001). 89 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 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 deviceK140408 Salvation Osteopenic ScrewWrightmedicaltechnologyinc · 2014
- Descendant · cites it directly · 0 of its ownK233816 REDEMPTION Charcot Plating SystemVilex, LLC · 2024
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 deviceK140408 Salvation Osteopenic ScrewWrightmedicaltechnologyinc · 2014
Most influential descendants
Showing 1 of 1 · See all- K233816REDEMPTION Charcot Plating SystemVilex, LLC · 2024 · cites it directly0descendants
View 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) | K140408 | Salvation Osteopenic Screw | Wrightmedicaltechnologyinc | 2014 | — |
| +1 | K233816 | REDEMPTION Charcot Plating System | Vilex, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 3 | 0 |
| 2000 | 9 | 0 |
| 2001 | 11 | 0 |
| 2002 | 10 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 6 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 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 |
|---|---|---|---|
| * | K110670 | VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Summary page 1…21 CFR 888.3040 - Class 11 Device Product Code, Device Panel: HWC: Screw, Fixation, Bone* (a)(3). Predicate Devices: K(110670: VLP FOOT Talus and Percutaneous Calcaneus Bone Plates,… | 2011 |
| * | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSummary page 1…crews; PERI-LOC Ankle Fusion Bone Plates and Instruments K090675: VLP FOOT Plating, Screw System, and Accessories (a)(4). Device Descript… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233816 | REDEMPTION Charcot Plating System | 2024 | 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?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 20 of the 89 ancestors have a recall of any class.
- Of its descendants, K233816 (Vilex, LLC, 2024) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K110670.
How does its category compare?
All HWC devicesHWC Screw, 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 · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The Salvation Osteopenic Screw is indicated for the treatment of fracture fixation, osteotomies, and reconstruction/arthrodeses of small bones, as well as patients with osteopenic bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140408 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140408: Salvation Osteopenic Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140408
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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