510(k) · Cleared
ClearedNormed Pellegrin Calcaneus Stop Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Normed Medizin-Technik GmbH · HWC Screw, Fixation, Bone
Cleared on Dec 13, 2013 as substantially equivalent to K111834 (Trilliant Surgical, Ltd., 2011) and 2 other predicates after a 77-day review. Its family tree reaches back 7 generations to 1980. 2 later devices descend from it.
- Decided
- Dec 13, 2013
- Review
- 77 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K792670 (1980). 16 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK792670 Smith Subtalar PegDow Corning Wright · 1980
- 6 generations backK960692 Subtalar Mba SystemKinetikos Medical, Inc. · 1996
- 5 generations backK051611 Mbaresorb ImplantKinetikos Medical, Inc. · 2005 · Recalled
- 4 generations backK071456 Arthrex Prostop Plus Arthroereisis Subtalar ImplantArthrex, Inc. · 2008
- 3 generations backK093820 Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090…Memometal Technologies · 2010
- 2 generations backK103183 Trilliant Surgical Subtalar ImplantTrilliant Surgical, Ltd. · 2011 · Recalled
- 1 generation backK111834 Disco Subtalar ImplantTrilliant Surgical, Ltd. · 2011 · Recalled
- This deviceK133035 Normed Pellegrin Calcaneus Stop ScrewNormed Medizin-Technik GmbH · 2013
- Descendant · cites it directly · 0 of its ownK160548 MC-Subtalar (TM) IIMerete Medical GmbH · 2016
- Descendant · cites it directly · 0 of its ownK140962 Normed Vario Subtalar ScrewNormed Nedizin Technik GmbH · 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 |
|---|---|---|---|---|---|
| −7 | K792670 | Smith Subtalar Peg | Dow Corning Wright | 1980 | — |
| −6 | K960692 | Subtalar Mba System | Kinetikos Medical, Inc. | 1996 | — |
| −5 | K051611 | Mbaresorb Implant | Kinetikos Medical, Inc. | 2005 | 3 |
| −4 | K071456 | Arthrex Prostop Plus Arthroereisis Subtalar Implant | Arthrex, Inc. | 2008 | — |
| −3 | K093820 | Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115 | Memometal Technologies | 2010 | — |
| −2 | K103183 | Trilliant Surgical Subtalar Implant | Trilliant Surgical, Ltd. | 2011 | 1 |
| −1 | K111834 | Disco Subtalar Implant | Trilliant Surgical, Ltd. | 2011 | 1 |
| 0 (this device) | K133035 | Normed Pellegrin Calcaneus Stop Screw | Normed Medizin-Technik GmbH | 2013 | — |
| +1 | K160548 | MC-Subtalar (TM) II | Merete Medical GmbH | 2016 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K111834 | Disco Subtalar ImplantSummary page 1…teners (21 CFR 888.3040) Class: 11 Product Code: HWC Predicate Device: Trilliant Surgical Disco Subtalar Implant, K 111834 (cleared 12/6/11) Tornier Futura Angled Subtalar Implant, K033046 (cleared 12/23/0… | 2011 |
| * | K033046 | Subtalar Peg ImplantSummary page 1…Surgical Disco Subtalar Implant, K 111834 (cleared 12/6/11) Tornier Futura Angled Subtalar Implant, K033046 (cleared 12/23/03) 510(k) Premnarket NotificationK135pae2o3 Nonn… | 2003 |
| * | K014154 | Vilex/Duval/Orthex Cannulated Bone Screw DB1 Thread, Model F25-XX-09; Vilex Solid Bone…Summary page 2…ae2o3 Nonned Pellegrin Calcaneus StopnScrew K133pae2o3 Multithr ead Vilex Cannulated Bone Screw, KO014154 (cleared 3/18/02) Device Description: The Nortned Peliegrin Calcaneus Stop Screws are threaded, cannula… | 2002 |
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)
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 33 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 16 ancestors have a recall of any class.
- Of its descendants, K160548 (Merete Medical GmbH, 2016) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Thte NormedS Pellegrin Calcaneus Stop Screw System is indicated for adult, children and adolescent patients.
The screws ame intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalarjoint motion but blocking excessive pmonation 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/K133035 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133035: Normed Pellegrin Calcaneus Stop Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133035
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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