510(k) · Cleared
ClearedSubtalar Spacer System (STS)
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 8, 2015 as substantially equivalent to K032682 (Ortho-Pro, LLC, 2003) and 1 other predicate after a 98-day review. Its family tree reaches back 3 generations to 1980.
- Decided
- May 8, 2015
- Review
- 98 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K792670 (1980). 4 ancestors in all. No later device cites it as a predicate yet.
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) | K150213 | Subtalar Spacer System (STS) | Wrightmedicaltechnologyinc | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 4…ded metallic bone fixation fastener Classification Name and Reference: 21 CFR 888.3040- Class I1 Device Product Code, Device Panel: HWC- Orthopedic 3; Predicate Device: K032682-Ortho-Pro STS Screw K070441-Metasurg Subtalar Implant 4, Device Description The Subtalar Spacer System (STS) a threaded implant… | 2003 |
| * | K070441 | Metasurg Subtalar ImplantSummary page 4…stener Classification Name and Reference: 21 CFR 888.3040- Class I1 Device Product Code, Device Panel: HWC- Orthopedic 3; Predicate Device: K032682-Ortho-Pro STS Screw K070441-Metasurg Subtalar Implant 4, Device Description The Subtalar Spacer System (STS) a threaded implant designed to be inserted betw… | 2007 |
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 35 years and passes through 4 companies; a new generation was cleared every 11.5 years on median.
- None of the 4 ancestors has a recall.
- 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. 2015, 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 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.
» 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150213 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150213: Subtalar Spacer System (STS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150213
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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