510(k) · Cleared
ClearedOsteomed Subtalar Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed LP · HWC Screw, Fixation, Bone
Cleared on Aug 22, 2003 as substantially equivalent to K960692 (Kinetikos Medical, Inc., 1996) after a 133-day review. Its family tree reaches back 2 generations to 1980. 16 later devices descend from it.
- Decided
- Aug 22, 2003
- Review
- 133 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K792670 (1980). 16 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK792670 Smith Subtalar PegDow Corning Wright · 1980
- 1 generation backK960692 Subtalar Mba SystemKinetikos Medical, Inc. · 1996
- This deviceK031155 Osteomed Subtalar Implant SystemOsteomed LP · 2003
- Descendant · cites it directly · 12 of its ownK080280 Sub-Talar Lok, Model 7-11 MMInstratek, Inc. · 2008
- Descendant · cites it directly · 8 of its ownK093820 Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090…Memometal Technologies · 2010
- Descendant · 2 generations on · 4 of its ownK103183 Trilliant Surgical Subtalar ImplantTrilliant Surgical, Ltd. · 2011 · Recalled
- Descendant · 3 generations on · 3 of its ownK111834 Disco Subtalar ImplantTrilliant Surgical, Ltd. · 2011 · Recalled
- Descendant · 4 generations on · 2 of its ownK133035 Normed Pellegrin Calcaneus Stop ScrewNormed Medizin-Technik GmbH · 2013
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K080280Sub-Talar Lok, Model 7-11 MMInstratek, Inc. · 2008 · cites it directly12descendants
- K093820Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115Memometal Technologies · 2010 · cites it directly8descendants
- K103183Trilliant Surgical Subtalar ImplantTrilliant Surgical, Ltd. · 2011 · 2 generations on4descendants
- K111834Disco Subtalar ImplantTrilliant Surgical, Ltd. · 2011 · 3 generations on3descendants
- K133035Normed Pellegrin Calcaneus Stop ScrewNormed Medizin-Technik GmbH · 2013 · 4 generations on2descendants
View 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) | K031155 | Osteomed Subtalar Implant System | Osteomed LP | 2003 | — |
| +1 | K080280 | Sub-Talar Lok, Model 7-11 MM | Instratek, Inc. | 2008 | — |
| +1 | K093820 | Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115 | Memometal Technologies | 2010 | — |
| +2 | K103183 | Trilliant Surgical Subtalar Implant | Trilliant Surgical, Ltd. | 2011 | 1 |
| +3 | K111834 | Disco Subtalar Implant | Trilliant Surgical, Ltd. | 2011 | 1 |
| +4 | K133035 | Normed Pellegrin Calcaneus Stop Screw | Normed Medizin-Technik GmbH | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2022 | 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…vice is based on similarities in intended use, material, design and operational principle to the Kinetikos Medical Subtalar MBA System (K960692). Due to the similarity of materials and design to the predicate device, OsteoMed believes tha… | 1996 |
What descends from it? (16)
See all 166 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080280 | Sub-Talar Lok, Model 7-11 MM | 2008 | 12 |
| K093820 | Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115 | 2010 | 8 |
| K113399 | Ifs Subtalar Implant | 2011 | 0 |
| K112658 | Osteospring Footjack Subtalar Implant System | 2011 | 0 |
| K081755 | Fusion Medical Sti | 2009 | 0 |
| K053543 | Arthrex Arthoeresis Implant | 2006 | 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 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, K080280 (Instratek, Inc., 2008) has gone furthest, with 12 descendants 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?
Indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the anterior and inferior displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
OsteoMed Subtalar Implants are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031155 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031155: Osteomed Subtalar Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031155
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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