510(k) · Cleared
Recalled · Class II · 20183S Hemi Toe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trilliant Surgical, Ltd. · KWD Prosthesis, Toe, Hemi-, Phalangeal
Cleared on Nov 28, 2007 as substantially equivalent to K971047 (Nexa Orthopedics, Inc., 1997) and 2 other predicates after a 44-day review. Its family tree reaches back 2 generations to 1987. It has been recalled once.
- Decided
- Nov 28, 2007
- Review
- 44 days
- Class
- Class II
- Product code
- KWD
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K864492 (1987). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K864492 | Swanson Titanium Great Toe Implant | Dow Corning Wright | 1987 | 1 |
| −1 | K971047 | Futura Biomedical Metal Hemi Toe Implant | Nexa Orthopedics, Inc. | 1997 | — |
| 0 (this device) | K072922 | 3S Hemi Toe | Trilliant Surgical, Ltd. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2002 | 2 | 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? (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 |
|---|---|---|---|
| * | K971047 | Futura Biomedical Metal Hemi Toe ImplantSummary page 1…888.3730 KW D 3. Predicate or legally marketed devices which are substantially equivalent: Futura Biomedical Metal Hemi Toe Implant (K971047), Kinetilkos Medical K2 Hemni Toe Implant System (K023770), and Townley Great Toe Joint (K91 1378). 4. Description of the… | 1997 |
| * | K023770 | K2 Hemi Toe Implant System (Formerly Zobel Great Toe Implant System)Summary page 1…lly marketed devices which are substantially equivalent: Futura Biomedical Metal Hemi Toe Implant (K971047), Kinetilkos Medical K2 Hemni Toe Implant System (K023770), and Townley Great Toe Joint (K91 1378). 4. Description of the device: The 3$ Hemi Toe is a single stemmed resurfacing pr… | 2002 |
| * | K911378 | Townley Great Toe JointSummary page 1…ially equivalent: Futura Biomedical Metal Hemi Toe Implant (K971047), Kinetilkos Medical K2 Hemni Toe Implant System (K023770), and Townley Great Toe Joint (K91 1378). 4. Description of the device: The 3$ Hemi Toe is a single stemmed resurfacing prosthesis for the first proximal phalanx… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 19, 2018 | Class II | Z-1611-2020 | Labeling Change Control | Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 10.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 5 other devices also cite its predicate K971047.
How does its category compare?
All KWD devicesKWD Prosthesis, Toe, Hemi-, Phalangeal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 3S Hemi Toe Implant is designed to supplement first metatarsal phalangeal joint arthroplasty. Indications include hallux limitus or hallux rigidius, painful hallux valgus, revision of failed previous surgery and painful arthritis. This device is for uncemented use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072922 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072922: 3S Hemi Toe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072922
Report an extraction error
Are you the manufacturer?
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