510(k) · Cleared
ClearedSTS Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Pro, LLC · HWC Screw, Fixation, Bone
Cleared on Oct 22, 2003 as substantially equivalent to K960692 (Kinetikos Medical, Inc., 1996) after a 54-day review. Its family tree reaches back 2 generations to 1980. 3 later devices descend from it.
- Decided
- Oct 22, 2003
- Review
- 54 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K792670 (1980). 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK792670 Smith Subtalar PegDow Corning Wright · 1980
- 1 generation backK960692 Subtalar Mba SystemKinetikos Medical, Inc. · 1996
- This deviceK032682 STS ScrewOrtho-Pro, LLC · 2003
- Descendant · cites it directly · 1 of its ownK093055 CSTS ScrewOrthopro, LLC · 2010
- Descendant · cites it directly · 0 of its ownK170624 TalarLift STSFusion Orthopedics, LLC · 2017
- Descendant · cites it directly · 0 of its ownK150213 Subtalar Spacer System (STS)Wrightmedicaltechnologyinc · 2015
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K792670 | Smith Subtalar Peg | Dow Corning Wright | 1980 | — |
| −1 | K960692 | Subtalar Mba System | Kinetikos Medical, Inc. | 1996 | — |
| 0 (this device) | K032682 | STS Screw | Ortho-Pro, LLC | 2003 | — |
| +1 | K093055 | CSTS Screw | Orthopro, LLC | 2010 | — |
| +1 | K170624 | TalarLift STS | Fusion Orthopedics, LLC | 2017 | — |
| +1 | K150213 | Subtalar Spacer System (STS) | Wrightmedicaltechnologyinc | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | K960692 | Subtalar Mba SystemSummary page 1…crew, fixation, bone (per 21 CFR section 888.3040 ) Equivalent Device The STS Screw is similar in design, indications and material as the Kinetikos Subtalar MBA System (K960692). Device Descriotion The Ortho-Pro STS Screw consists of a threaded implant, designed to be inserted between the posterior and m… | 1996 |
What descends from it? (3)
3 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 23 years and passes through 3 companies; a new generation was cleared every 16.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K093055 (Orthopro, LLC, 2010) has gone furthest, with 1 descendant of its own.
- 8 other devices also cite its predicate K960692.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 STS 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
Walking intemperance
Calcaneal stance position greater than 5"
Manually correctable deformities
Mid-tarsal breech (arch pain)
Forefoot varus greater than 10%
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032682 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032682: STS Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032682
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