510(k) · Cleared
ClearedGaitway Implant System, Surgical Instrument Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Solana Surgical, LLC · HWC Screw, Fixation, Bone
Cleared on Nov 7, 2012 as substantially equivalent to K093820 (Memometal Technologies, 2010) and 2 other predicates after a 62-day review. Its family tree reaches back 5 generations to 1980. 2 later devices descend from it.
- Decided
- Nov 7, 2012
- Review
- 62 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K792670 (1980). 12 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK792670 Smith Subtalar PegDow Corning Wright · 1980
- 4 generations backK960692 Subtalar Mba SystemKinetikos Medical, Inc. · 1996
- 3 generations backK051611 Mbaresorb ImplantKinetikos Medical, Inc. · 2005 · Recalled
- 2 generations backK071456 Arthrex Prostop Plus Arthroereisis Subtalar ImplantArthrex, Inc. · 2008
- 1 generation backK093820 Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090…Memometal Technologies · 2010
- This deviceK122738 Gaitway Implant System, Surgical Instrument SetSolana Surgical, LLC · 2012
- Descendant · cites it directly · 1 of its ownK170688 PIT’Stop® implantIn2bones Sas · 2017
- Descendant · 2 generations on · 0 of its ownK222820 BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K792670 | Smith Subtalar Peg | Dow Corning Wright | 1980 | — |
| −4 | K960692 | Subtalar Mba System | Kinetikos Medical, Inc. | 1996 | — |
| −3 | K051611 | Mbaresorb Implant | Kinetikos Medical, Inc. | 2005 | 3 |
| −2 | K071456 | Arthrex Prostop Plus Arthroereisis Subtalar Implant | Arthrex, Inc. | 2008 | — |
| −1 | K093820 | Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115 | Memometal Technologies | 2010 | — |
| 0 (this device) | K122738 | Gaitway Implant System, Surgical Instrument Set | Solana Surgical, LLC | 2012 | — |
| +1 | K170688 | PIT’Stop® implant | In2bones Sas | 2017 | — |
| +2 | K222820 | BRM TOOL Screws, BIOPLAN Subtalar Implant | Brm Extremities | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K093820 | Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115Summary page 1…tion Number: 21 CFR 888.3040 Product Code: HWC Predicate Devices: K093820 Memometal SubFix Arthroereisis Implant… | 2010 |
| * | K080280 | Sub-Talar Lok, Model 7-11 MMSummary page 1…K093820 Memometal SubFix Arthroereisis Implant K080280 Instratek, INC.Sub-Talar Lok, Model 7-11 mm… | 2008 |
| * | K071456 | Arthrex Prostop Plus Arthroereisis Subtalar ImplantSummary page 1…K080280 Instratek, INC.Sub-Talar Lok, Model 7-11 mm K071456 Arthrex Pro Stop Plus Device Description:, The, Solana Surgical Gaitway Implant is a one-piece device made of Titanium Alloy int… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170688 | PIT’Stop® implant | 2017 | 1 |
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 32 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K170688 (In2bones Sas, 2017) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K093820.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Solana Surgical LLC, Gaitway Implant System is intended to treat the hyperpronated foot and stabilize the subtalar joint. It is intended to block forward, downward and medial displacement of the talus, thus blocking excessive pronation and the resulting sequela.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122738 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122738: Gaitway Implant System, Surgical Instrument Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122738
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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