510(k) · Cleared
ClearedFusion Silastic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fusion Orthopedics, LLC · KWH Prosthesis, Toe, Constrained, Polymer
Cleared on Oct 21, 2019 after a 265-day review. The FDA summary names its predicate without a number.
- Decided
- Oct 21, 2019
- Review
- 265 days
- Class
- Class II
- Product code
- KWH
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 KWH? 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 KWH device
- #1 K191966 NewPrim Systemscore -0.6 · 3 generations · no Class I recall
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | — | Flexible Hinge Toe Implant Named without a submission number | |
| * | — | Silastic Lesser Toe Implant Named without a submission number | |
| * | — | Silicone Hammertoe Implant Named without a submission number | |
| * | — | Flexible NPM Implant w/Grommets Named without a submission number |
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.
How does its category compare?
All KWH devicesKWH Prosthesis, Toe, Constrained, Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · KWH
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · KWH
Too few KWH 510(k)s in any year since 2007 to give a median.
Recalls per year · KWH
2in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWH
8in 2025
MAUDE reports naming product code KWH, 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 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 2 | 5 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 1 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 7 |
| 2019 | 1 | — | 0 | 15 |
| 2020 | 1 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The GAIT Implants are intended for patients presenting with class 3 degeneration of the first metatarsophalangeal joint with narrowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful range of motion of the first metatarsophalangeal joint both with rotation and with walking. This application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAIT Implant…
Read the full statement (461 words)
The GAIT Implants are intended for patients presenting with class 3 degeneration of the first metatarsophalangeal joint
with narrowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful range of
motion of the first metatarsophalangeal joint both with rotation and with walking. This application is not expected to
recreate a normal range of motion of the first metatarsophalangeal joint. The GAIT Implant is a spacer that augments the
Keller arthroplasty procedure by stabilizing the hallux to the first metatarsal.
The GAIT Implants w/Grommets are intended for patients presenting with class 3 degeneration of the first
metatarsophalangeal joint with narrowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint
space, and a painful range of motion of the first metatarsophalangeal joint both with rotation and with walking. This
application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAIT Implant
is a spacer that augments the Keller arthroplasty procedure by stabilizing the hallux to the first metatarsal.
The GAIT 2.0 Implants are intended for patients presenting with class 3 degeneration of the first metatarsophalangeal
joint with narrowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint space, and a painful
range of motion of the first metatarsophalangeal joint both with rotation and with walking. This application is not
expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAIT Implant is a spacer that
augments the Keller arthroplasty procedure by stabilizing the hallux to the first metatarsal.
The GAIT 2.0 Implants w/Grommets are intended for patients presenting with class 3 degeneration of the first
metatarsophalangeal joint with narrowing of the joint space, loss of joint cartilage, bony spur ring surrounding the joint
space, and a painful range of motion of the first metatarsophalangeal joint both with rotation and with walking. This
application is not expected to recreate a normal range of motion of the first metatarsophalangeal joint. The GAIT Implant
is a spacer that augments the Keller arthroplasty procedure by stabilizing the hallux to the first metatarsal.
The SHIP Long Implants, are intended for patients presenting with the following indications commonly found in the
interphalangeal joints: Semi-rigid or rigid hammertoe deformity; Angular deformity; Impaired function and stability; Pain;
Impaired toe length ratio.
The Shaw Rod Implant is intended for patients presenting with the following indications commonly found in the
interphalangeal joints: Semi-rigid or rigid hammertoe deformity; Angular deformity; Impaired function and stability; Pain;
Impaired toe length ratio.
The SHIP Short Implants are intended for patients presenting with the following indications commonly found in the
interphalangeal joints: Semi-rigid or rigid hammertoe deformity; Angular deformity; Impaired function and stability; Pain;
Impaired toe length ratio.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190136 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190136: Fusion Silastic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190136
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026