510(k) · Cleared
ClearedHemi Phalangeal Implant Surgical Instrument Set
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 Feb 6, 2012 as substantially equivalent to K023684 (Vilex, Inc., 2004) and 1 other predicate after a 33-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Feb 6, 2012
- Review
- 33 days
- Class
- Class II
- Product code
- KWD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K014164 (2002). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK014164 Great Toe Implant SystemHarmos Orthopaedics, Inc. · 2002
- 1 generation backK023770 K2 Hemi Toe Implant System (Formerly Zobel Great Toe Implant System)Kinetikos Medical, Inc. · 2002
- This deviceK120029 Hemi Phalangeal Implant Surgical Instrument SetSolana Surgical, LLC · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K014164 | Great Toe Implant System | Harmos Orthopaedics, Inc. | 2002 | — |
| −1 | K023770 | K2 Hemi Toe Implant System (Formerly Zobel Great Toe Implant System) | Kinetikos Medical, Inc. | 2002 | — |
| 0 (this device) | K120029 | Hemi Phalangeal Implant Surgical Instrument Set | Solana Surgical, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 |
|---|---|---|---|
| * | K023684 | Cannulated Metallic Hemi Toe Implant, Models MPJ241975, MPJ221775, MPJ211675, MPJ191565…Summary page 1…thopedic Regulation Number: 21 CFR 888.3730 Product Code: KWD Predicate Device: K023684 Vilex, K023770 Kinetikos Medical Device Description: The Solana Surgical Implant… | 2004 |
| * | K023770 | K2 Hemi Toe Implant System (Formerly Zobel Great Toe Implant System)Summary page 1…888.3730 Product Code: KWD Predicate Device: K023684 Vilex, K023770 Kinetikos Medical Device Description: The Solana Surgical Implant is a one-piece device made of Cobalt Chromium (with titanium… | 2002 |
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 10 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- None of the 3 ancestors has a recall.
- 5 other devices also cite its predicate K023684.
How does its category compare?
All KWD devicesKWD Prosthesis, Toe, Hemi-, Phalangeal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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, Hemi Phalangeal Implant System is intended for use as a hemi-arthroplasty implant for the 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 or press fit without bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120029 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120029: Hemi Phalangeal Implant 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/K120029
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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