510(k) · Cleared
ClearedNormed Vario Subtalar Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Normed Nedizin Technik GmbH · HWC Screw, Fixation, Bone
Cleared on Jul 3, 2014 as substantially equivalent to K133035 (Normed Medizin-Technik GmbH, 2013) and 2 other predicates after a 79-day review. Its family tree reaches back 8 generations to 1980.
- Decided
- Jul 3, 2014
- Review
- 79 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K792670 (1980). 18 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK792670 Smith Subtalar PegDow Corning Wright · 1980
- 7 generations backK960692 Subtalar Mba SystemKinetikos Medical, Inc. · 1996
- 6 generations backK051611 Mbaresorb ImplantKinetikos Medical, Inc. · 2005 · Recalled
- 5 generations backK071456 Arthrex Prostop Plus Arthroereisis Subtalar ImplantArthrex, Inc. · 2008
- 4 generations backK093820 Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090…Memometal Technologies · 2010
- 3 generations backK103183 Trilliant Surgical Subtalar ImplantTrilliant Surgical, Ltd. · 2011 · Recalled
- 2 generations backK111834 Disco Subtalar ImplantTrilliant Surgical, Ltd. · 2011 · Recalled
- 1 generation backK133035 Normed Pellegrin Calcaneus Stop ScrewNormed Medizin-Technik GmbH · 2013
- This deviceK140962 Normed Vario Subtalar ScrewNormed Nedizin Technik GmbH · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K792670 | Smith Subtalar Peg | Dow Corning Wright | 1980 | — |
| −7 | K960692 | Subtalar Mba System | Kinetikos Medical, Inc. | 1996 | — |
| −6 | K051611 | Mbaresorb Implant | Kinetikos Medical, Inc. | 2005 | 3 |
| −5 | K071456 | Arthrex Prostop Plus Arthroereisis Subtalar Implant | Arthrex, Inc. | 2008 | — |
| −4 | K093820 | Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115 | Memometal Technologies | 2010 | — |
| −3 | K103183 | Trilliant Surgical Subtalar Implant | Trilliant Surgical, Ltd. | 2011 | 1 |
| −2 | K111834 | Disco Subtalar Implant | Trilliant Surgical, Ltd. | 2011 | 1 |
| −1 | K133035 | Normed Pellegrin Calcaneus Stop Screw | Normed Medizin-Technik GmbH | 2013 | — |
| 0 (this device) | K140962 | Normed Vario Subtalar Screw | Normed Nedizin Technik GmbH | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 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? (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 |
|---|---|---|---|
| * | K133035 | Normed Pellegrin Calcaneus Stop ScrewSummary page 1…rs (21 CFR 888.3040) Class: 11 Product Code: HWC Predicate Device: Normed Pellegrin Calcaneus Stop Screw, K133035 (cleared 12/13/13) 15… | 2013 |
| * | K093820 | Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115Summary page 2…tionK106pae2o3 Normed Varlo Subtalar Screw Memom etal Technologies SubFix Arthroereisis Implant, K093820 (cleared 5/19/10) Metasurg Subtalar Implant, K I 11265 (… | 2010 |
| * | K111265 | Metasurg Subtalar Implant | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 34 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 18 ancestors have a recall of any class.
- 1 other device also cites its predicate K133035.
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 Vario Subtalar Screw System is indicated for adult, children and adolescent patients.
The screws are intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
Adult - additive subtalar alignment for flat foot.
Children - flexible flat foot treatment in children and adolescents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140962 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140962: Normed Vario Subtalar Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140962
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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