510(k) · Cleared
ClearedCSTS Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthopro, LLC · HWC Screw, Fixation, Bone
Cleared on Nov 22, 2010 as substantially equivalent to K032682 (Ortho-Pro, LLC, 2003) and 1 other predicate after a 418-day review. Its family tree reaches back 3 generations to 1980. 1 later device descends from it.
- Decided
- Nov 22, 2010
- Review
- 418 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K792670 (1980). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK792670 Smith Subtalar PegDow Corning Wright · 1980
- 2 generations backK960692 Subtalar Mba SystemKinetikos Medical, Inc. · 1996
- 1 generation backK032682 STS ScrewOrtho-Pro, LLC · 2003
- This deviceK093055 CSTS ScrewOrthopro, LLC · 2010
- Descendant · cites it directly · 0 of its ownK170624 TalarLift STSFusion Orthopedics, LLC · 2017
Most influential descendants
Showing 1 of 1 · See all- K170624TalarLift STSFusion Orthopedics, LLC · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K792670 | Smith Subtalar Peg | Dow Corning Wright | 1980 | — |
| −2 | K960692 | Subtalar Mba System | Kinetikos Medical, Inc. | 1996 | — |
| −1 | K032682 | STS Screw | Ortho-Pro, LLC | 2003 | — |
| 0 (this device) | K093055 | CSTS Screw | Orthopro, LLC | 2010 | — |
| +1 | K170624 | TalarLift STS | Fusion Orthopedics, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K032682 | STS ScrewSummary page 1…HWC Class 11 3. Predicate or legally marketed devices which are substantially equivalent: OrthoPro STS Screw (K032682) Futura Biomedical Arthrorisis Implant (K032902) 4. Description of the device: The Ortho-Pro CSTS Screw consi… | 2003 |
| * | K032902 | Subtalar Arthrorisis ImplantSummary page 1…11 3. Predicate or legally marketed devices which are substantially equivalent: OrthoPro STS Screw (K032682) Futura Biomedical Arthrorisis Implant (K032902) 4. Description of the device: The Ortho-Pro CSTS Screw consists of a threaded implant, designed to be inserted betwee… | 2003 |
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 |
|---|---|---|---|
| K170624 | TalarLift STS | 2017 | 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 30 years and passes through 4 companies; a new generation was cleared every 7.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K170624 (Fusion Orthopedics, LLC, 2017) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K032682.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Ortho-Pro CSTS Screw is indicated for use in treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the posterior and inferior displacement of the talus, thus allowing normal subtalar joint motion while blocking excessive pronation and the resulting sequela. It is appropriate for the following conditions:
* Severely pronated foot
* Calcaneal stance position greater than 50
* Manually correctable deformities
* Mid-tarsal breech (arch pain)
* Forefoot varus greater than 100
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093055 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093055: CSTS Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093055
Report an extraction error
Are you the manufacturer?
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