510(k) · Cleared
Recalled · Class II · 2018Hammer Toe Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trilliant Surgical, Ltd. · HWC Screw, Fixation, Bone
Cleared on Nov 7, 2012 as substantially equivalent to K111536 (Metasurg, 2011) and 1 other predicate after a 43-day review. Its family tree reaches back 4 generations to 2002. 22 later devices descend from it. It has been recalled once.
- Decided
- Nov 7, 2012
- Review
- 43 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K013888 (2002). 12 ancestors in all, the oldest K954330 (1995). 22 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK013888 Fixation (Steinmann) PinsMiltex, Inc. · 2002
- 3 generations backK031050 PCW Percutaneous Compression WireMillennium Medical Technologies, Inc. · 2003
- 2 generations backK062863 Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP · 2006
- 1 generation backK111536 Metasurg Digifuse ImplantMetasurg · 2011
- This deviceK122959 Hammer Toe ImplantTrilliant Surgical, Ltd. · 2012
- Descendant · cites it directly · 20 of its ownK140148 Pro-Toe Hammertoe Fixation SystemWrightmedicaltechnologyinc · 2014
- Descendant · 2 generations on · 9 of its ownK142585 PhaLinx Hammertoe SystemWrightmedicaltechnologyinc · 2014
- Descendant · 2 generations on · 6 of its ownK150252 PHALINX Hammertoe SystemWrightmedicaltechnologyinc · 2015
- Descendant · 2 generations on · 4 of its ownK151838 PRO-TOE Hammertoe Fixation SystemWrightmedicaltechnologyinc · 2015
- Descendant · 3 generations on · 3 of its ownK200840 DuoHex CH Cannulated Hammertoe SystemNextremity Solutions, Inc. · 2020 · Recalled
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K140148Pro-Toe Hammertoe Fixation SystemWrightmedicaltechnologyinc · 2014 · cites it directly20descendants
- K142585PhaLinx Hammertoe SystemWrightmedicaltechnologyinc · 2014 · 2 generations on9descendants
- K150252PHALINX Hammertoe SystemWrightmedicaltechnologyinc · 2015 · 2 generations on6descendants
- K151838PRO-TOE Hammertoe Fixation SystemWrightmedicaltechnologyinc · 2015 · 2 generations on4descendants
- K200840DuoHex CH Cannulated Hammertoe SystemNextremity Solutions, Inc. · 2020 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K013888 | Fixation (Steinmann) Pins | Miltex, Inc. | 2002 | — |
| −3 | K031050 | PCW Percutaneous Compression Wire | Millennium Medical Technologies, Inc. | 2003 | — |
| −2 | K062863 | Osteomed Extended 2.0/2.4CANNULATED Screw System | Osteomed LP | 2006 | — |
| −1 | K111536 | Metasurg Digifuse Implant | Metasurg | 2011 | — |
| 0 (this device) | K122959 | Hammer Toe Implant | Trilliant Surgical, Ltd. | 2012 | — |
| +1 | K140148 | Pro-Toe Hammertoe Fixation System | Wrightmedicaltechnologyinc | 2014 | — |
| +2 | K142585 | PhaLinx Hammertoe System | Wrightmedicaltechnologyinc | 2014 | — |
| +2 | K150252 | PHALINX Hammertoe System | Wrightmedicaltechnologyinc | 2015 | — |
| +2 | K151838 | PRO-TOE Hammertoe Fixation System | Wrightmedicaltechnologyinc | 2015 | — |
| +3 | K200840 | DuoHex CH Cannulated Hammertoe System | Nextremity Solutions, Inc. | 2020 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K111536 | Metasurg Digifuse ImplantSummary page 1…Product Code: HWC CFR section: 21 CFR section 888.3040 Device panel: Orthopedic Legally Marketed DigiFuse TM - K1 11536 Predicate Device: Tiger Cannulated Screws - K081510 Submitter: Trilliant Surgical LTD… | 2011 |
| * | K081510 | Tiger Cannulated Screw SystemSummary page 1…CFR section 888.3040 Device panel: Orthopedic Legally Marketed DigiFuse TM - K1 11536 Predicate Device: Tiger Cannulated Screws - K081510 Submitter: Trilliant Surgical LTD 630 W. 13th St… | 2008 |
What descends from it? (22)
See all 222 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 19, 2018 | Class II | Z-1610-2020 | 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 10 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K140148 (Wrightmedicaltechnologyinc, 2014) has gone furthest, with 20 descendants of its own.
- 5 other devices also cite its predicate K111536.
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 Hammer Toe System implants are intended for fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the lesser toes and fingers. Indications include: hammer toe deformity, claw toe deformity, mallet toe deformity, and other deformities of the foot and hand.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122959 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122959: Hammer Toe Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122959
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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