510(k) · Cleared
ClearedIfs Subtalar Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Internal Fixation Systems, Inc. · HWC Screw, Fixation, Bone
Cleared on Dec 20, 2011 as substantially equivalent to K032902 (Nexa Orthopedics, Inc., 2003) and 1 other predicate after a 33-day review. Its family tree reaches back 3 generations to 1980.
- Decided
- Dec 20, 2011
- Review
- 33 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. No later device cites it as a predicate yet.
- Root · 3 generations backK792670 Smith Subtalar PegDow Corning Wright · 1980
- 2 generations backK960692 Subtalar Mba SystemKinetikos Medical, Inc. · 1996
- 1 generation backK031155 Osteomed Subtalar Implant SystemOsteomed LP · 2003
- This deviceK113399 Ifs Subtalar ImplantInternal Fixation Systems, Inc. · 2011
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 | K031155 | Osteomed Subtalar Implant System | Osteomed LP | 2003 | — |
| 0 (this device) | K113399 | Ifs Subtalar Implant | Internal Fixation Systems, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K032902 | Subtalar Arthrorisis ImplantSummary page 1…r Regulation Number: 21 CFR 888.3040 Regulatory Class: if Device Product HWC Code: Substantially Nexa Subtalar Arthrorisis Implant (K032902) Equivalent Devices: Osteomed Subtalar Implant System (K031 155) Device Description: The IFS Subtalar Implant is a one-piece… | 2003 |
| * | K031155 | Osteomed Subtalar Implant SystemSummary page 1…lass: if Device Product HWC Code: Substantially Nexa Subtalar Arthrorisis Implant (K032902) Equivalent Devices: Osteomed Subtalar Implant System (K031 155) Device Description: The IFS Subtalar Implant is a one-piece device made of Ti 6A1-4V ELI intended to be… | 2003 |
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 31 years and passes through 4 companies; a new generation was cleared every 8.3 years on median.
- None of the 5 ancestors has a recall.
- 5 other devices also cite its predicate K032902.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 IFS Subtalar Implant is intended to treat hyperpronated foot and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113399 · printed Nov 5, 2026
Cite this page
510(k) Report. “K113399: Ifs Subtalar Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K113399
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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