510(k) · Cleared
Recalled · Class II · 2018Trilliant Surgical Subtalar 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 Feb 8, 2011 as substantially equivalent to K960692 (Kinetikos Medical, Inc., 1996) and 2 other predicates after a 103-day review. Its family tree reaches back 5 generations to 1980. 4 later devices descend from it. It has been recalled once.
- Decided
- Feb 8, 2011
- Review
- 103 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 5 generations to K792670 (1980). 13 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK792670 Smith Subtalar PegDow Corning Wright · 1980
- 4 generations backK960692 Subtalar Mba SystemKinetikos Medical, Inc. · 1996
- 3 generations backK051611 Mbaresorb ImplantKinetikos Medical, Inc. · 2005 · Recalled
- 2 generations backK071456 Arthrex Prostop Plus Arthroereisis Subtalar ImplantArthrex, Inc. · 2008
- 1 generation backK093820 Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090…Memometal Technologies · 2010
- This deviceK103183 Trilliant Surgical Subtalar ImplantTrilliant Surgical, Ltd. · 2011
- Descendant · cites it directly · 3 of its ownK111834 Disco Subtalar ImplantTrilliant Surgical, Ltd. · 2011 · Recalled
- Descendant · 2 generations on · 2 of its ownK133035 Normed Pellegrin Calcaneus Stop ScrewNormed Medizin-Technik GmbH · 2013
- Descendant · 3 generations on · 0 of its ownK160548 MC-Subtalar (TM) IIMerete Medical GmbH · 2016
- Descendant · 3 generations on · 0 of its ownK140962 Normed Vario Subtalar ScrewNormed Nedizin Technik GmbH · 2014
Most influential descendants
Showing 4 of 4 · See all- K111834Disco Subtalar ImplantTrilliant Surgical, Ltd. · 2011 · cites it directly3descendants
- K133035Normed Pellegrin Calcaneus Stop ScrewNormed Medizin-Technik GmbH · 2013 · 2 generations on2descendants
- K160548MC-Subtalar (TM) IIMerete Medical GmbH · 2016 · 3 generations on0descendants
- K140962Normed Vario Subtalar ScrewNormed Nedizin Technik GmbH · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K792670 | Smith Subtalar Peg | Dow Corning Wright | 1980 | — |
| −4 | K960692 | Subtalar Mba System | Kinetikos Medical, Inc. | 1996 | — |
| −3 | K051611 | Mbaresorb Implant | Kinetikos Medical, Inc. | 2005 | 3 |
| −2 | K071456 | Arthrex Prostop Plus Arthroereisis Subtalar Implant | Arthrex, Inc. | 2008 | — |
| −1 | K093820 | Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115 | Memometal Technologies | 2010 | — |
| 0 (this device) | K103183 | Trilliant Surgical Subtalar Implant | Trilliant Surgical, Ltd. | 2011 | — |
| +1 | K111834 | Disco Subtalar Implant | Trilliant Surgical, Ltd. | 2011 | 1 |
| +2 | K133035 | Normed Pellegrin Calcaneus Stop Screw | Normed Medizin-Technik GmbH | 2013 | — |
| +3 | K160548 | MC-Subtalar (TM) II | Merete Medical GmbH | 2016 | — |
| +3 | K140962 | Normed Vario Subtalar Screw | Normed Nedizin Technik GmbH | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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? (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 |
|---|---|---|---|
| * | K960692 | Subtalar Mba SystemSummary page 1…ich are substantially equivalent: The Trilliant Surgical Subtalar Implant is substantially equivalent to the following devices: * Subtalar MBA System, K960692 (Kinetikos Medical, Inc.) * HyProCure Subtalar Implant System, K042030 (GraMedica Medical Technologies, LLC)… | 1996 |
| * | K042030 | Hyprocure Subtalar Implant SystemSummary page 1…substantially equivalent to the following devices: * Subtalar MBA System, K960692 (Kinetikos Medical, Inc.) * HyProCure Subtalar Implant System, K042030 (GraMedica Medical Technologies, LLC) * Subtalar Arthroereisis Implant, K093820 (Memometal Technologies) 4. Descri… | 2004 |
| * | K093820 | Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115Summary page 1…92 (Kinetikos Medical, Inc.) * HyProCure Subtalar Implant System, K042030 (GraMedica Medical Technologies, LLC) * Subtalar Arthroereisis Implant, K093820 (Memometal Technologies) 4. Description of the device: The Trilliant Surgical Subtalar Implant consists of a threaded… | 2010 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111834 | Disco Subtalar Implant | 2011 | 3 |
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-1607-2020 | 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 31 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K111834 (Trilliant Surgical, Ltd., 2011) has gone furthest, with 3 descendants of its own.
- 8 other devices also cite its predicate K960692.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Trilliant Surgical Subtalar Implant is indicated for the use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is intended to block the forward, downward, and medial displacement of the talus, thus allowing normal subtalar joint motion but limiting excessive pronation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103183 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103183: Trilliant Surgical Subtalar Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103183
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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