510(k) · Cleared
ClearedMetatarsal Decompression Implant, Model 100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Solana Surgical, LLC · KWD Prosthesis, Toe, Hemi-, Phalangeal
Cleared on May 1, 2009 as substantially equivalent to K070052 (Vilex, Inc., 2007) and 1 other predicate after a 100-day review. Its family tree reaches back 4 generations to 1987. 2 later devices descend from it.
- Decided
- May 1, 2009
- Review
- 100 days
- Class
- Class II
- Product code
- KWD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K864492 (1987). 9 ancestors in all, the oldest K781870 (1979). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK864492 Swanson Titanium Great Toe ImplantDow Corning Wright · 1987 · Recalled
- 3 generations backK971047 Futura Biomedical Metal Hemi Toe ImplantNexa Orthopedics, Inc. · 1997
- 2 generations backK031859 Cap Great Toe Resurfacing Hemi-Arthroplasty ImplantArthrosurface, Inc. · 2004
- 1 generation backK070052 Met-Head Model# MHDD-XX:CC Diameter, CC CannulationVilex, Inc. · 2007
- This deviceK090127 Metatarsal Decompression Implant, Model 100Solana Surgical, LLC · 2009
- Descendant · cites it directly · 0 of its ownK201393 restor3d MTP ImplantRestor3D, Inc. · 2022 · Recalled
- Descendant · cites it directly · 0 of its ownK161279 Life Spine Metatarsal Hemi ImplantLife Spine, Inc. · 2017
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 |
|---|---|---|---|---|---|
| −4 | K864492 | Swanson Titanium Great Toe Implant | Dow Corning Wright | 1987 | 1 |
| −3 | K971047 | Futura Biomedical Metal Hemi Toe Implant | Nexa Orthopedics, Inc. | 1997 | — |
| −2 | K031859 | Cap Great Toe Resurfacing Hemi-Arthroplasty Implant | Arthrosurface, Inc. | 2004 | — |
| −1 | K070052 | Met-Head Model# MHDD-XX:CC Diameter, CC Cannulation | Vilex, Inc. | 2007 | — |
| 0 (this device) | K090127 | Metatarsal Decompression Implant, Model 100 | Solana Surgical, LLC | 2009 | — |
| +1 | K201393 | restor3d MTP Implant | Restor3D, Inc. | 2022 | 1 |
| +1 | K161279 | Life Spine Metatarsal Hemi Implant | Life Spine, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1991 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 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 KWD? 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 KWD device
- #1 K250074 HYALEX® MTP Hemiarthroplasty Implantscore 13.2 · 8 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 |
|---|---|---|---|
| * | K070052 | Met-Head Model# MHDD-XX:CC Diameter, CC CannulationSummary page 1…Orthopedic Regulation Number: 888.3730 Product Code: KWD Predicate Device: K070052 Vilex, Met-Head, Resurfacing Hemi-Arthroplasty Implant… | 2007 |
| * | K031859 | Cap Great Toe Resurfacing Hemi-Arthroplasty ImplantSummary page 1…K070052 Vilex, Met-Head, Resurfacing Hemi-Arthroplasty Implant K031859 Arthrosurface, CAP Great Toe Resurfacing Hemi-Arthroplasty Implant Registration Nu… | 2004 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 5 companies; a new generation was cleared every 6.7 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K201393 (Restor3D, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K070052.
How does its category compare?
All KWD devicesKWD Prosthesis, Toe, Hemi-, Phalangeal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · KWD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KWD
47in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWD
10in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWD
8in 2025
MAUDE reports naming product code KWD, 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 | 5 | 65 | 0 | 0 |
| 2008 | 3 | 84 | 1 | 2 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 3 | 47 | 0 | 1 |
| 2013 | 2 | — | 0 | 4 |
| 2014 | 0 | — | 1 | 3 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 1 | — | 1 | 7 |
| 2017 | 1 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 2 | — | 0 | 19 |
| 2020 | 1 | — | 0 | 4 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 2 | — | 10 | 10 |
| 2023 | 1 | — | 0 | 27 |
| 2024 | 1 | — | 0 | 133 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Solana Surgical LLC, Metatarsal Decompression Implant is intended for use as a hemi-arthroplasty implant for the first metatarsophalangeal joint, for the treatment of degenerative and post-traumatic arthritis, hallux valgus, hallux rigidus, and an unstable or painful metatarsophalangeal (MTP) joint.
The device is intended for single use to be used with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090127 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090127: Metatarsal Decompression Implant, Model 100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090127
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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