510(k) · Cleared
ClearedTrident Extremity Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trident Orthopedics · HRS Plate, Fixation, Bone
Cleared on May 8, 2018 as substantially equivalent to K151235 (Medline Industries, Inc., 2015) and 3 other predicates after a 335-day review. Its family tree reaches back 11 generations to 1996.
- Decided
- May 8, 2018
- Review
- 335 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K954385 (1996). 66 ancestors in all, the oldest K895117 (1990). No later device cites it as a predicate yet.
- Root · 11 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 7 generations between
- 3 generations backK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
- 2 generations backK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
- 1 generation backK151235 Medline Foot Plates and ScrewsMedline Industries, Inc. · 2015
- This deviceK171690 Trident Extremity Fixation SystemTrident Orthopedics · 2018
Show all 11 generations
- Root · 11 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 10 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 9 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 8 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 7 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 6 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 5 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 4 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 3 generations backK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
- 2 generations backK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
- 1 generation backK151235 Medline Foot Plates and ScrewsMedline Industries, Inc. · 2015
- This deviceK171690 Trident Extremity Fixation SystemTrident Orthopedics · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −10 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −9 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −8 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −7 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −6 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −5 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −4 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −3 | K113014 | Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws | Wrightmedicaltechnologyinc | 2012 | 12 |
| −2 | K121651 | Ortholoc 3DI Midfoot/Flatfoot System | Wrightmedicaltechnologyinc | 2012 | — |
| −1 | K151235 | Medline Foot Plates and Screws | Medline Industries, Inc. | 2015 | — |
| 0 (this device) | K171690 | Trident Extremity Fixation System | Trident Orthopedics | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 5 | 0 |
| 2010 | 5 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2015 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K151235 | Medline Foot Plates and ScrewsSummary page 5…HWC: Screw, Fixation, Bone Predicate Devices 510(k) # Manufacturer Primary Predicate: K151235 Medline Medline Foot Plates and Screws Secondary Predicate: K991151, Vilex, Inc. Vilex… | 2015 |
| * | K991151 | Vilex Cannulated Bone Screw, Duval Cannulated Bone Screw, Orthex Cannulated Bone ScrewSummary page 5…Manufacturer Primary Predicate: K151235 Medline Medline Foot Plates and Screws Secondary Predicate: K991151, Vilex, Inc. Vilex Cannulated Bone Screw/DuVal K991197 Cannulated Bone Screw Secondary Predicate:… | 1999 |
| * | K991197 | Vilex/Duval/Orthex Cannulated Bone Screw, Models P222-XX, S25-XX, P227-XX, S30-XX…Summary page 5…Medline Medline Foot Plates and Screws Secondary Predicate: K991151, Vilex, Inc. Vilex Cannulated Bone Screw/DuVal K991197 Cannulated Bone Screw Secondary Predicate: K151021 Osteomed, Corp. Osteomed Cannulated Scre… | 1999 |
| * | K151021 | OsteoMed Cannulated Screw SystemSummary page 5…K991151, Vilex, Inc. Vilex Cannulated Bone Screw/DuVal K991197 Cannulated Bone Screw Secondary Predicate: K151021 Osteomed, Corp. Osteomed Cannulated Screw System Description The Subject device is manufactured from titani… | 2015 |
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 22 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 14 of the 66 ancestors have a recall of any class.
- 5 other devices also cite its predicate K151235.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The Trident Extremity Fixation System consisting of plates and screws are intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of bone of the feet, hand, ankle and toes. Specific examples include: - Arthrodesis of the first metatarsalcuneiform joint (Lapidus fusion procedure) - Arthrodesis of the first metatarsalphalangeal joint (MTP fusion procedure) - Primary and revision MTP fusion due…
Read the full statement (235 words)
The Trident Extremity Fixation System consisting of plates and screws are intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of bone of the feet, hand, ankle and toes. Specific examples include:
- Arthrodesis of the first metatarsalcuneiform joint (Lapidus fusion procedure)
- Arthrodesis of the first metatarsalphalangeal joint (MTP fusion procedure)
- Primary and revision MTP fusion due to hallux rigidus and/or hallux valgus corrections
- Revision of failed first MTP arthroplasty implant 2nd, 3rd and 4th metatarsal weil osteotomy correction indications
- Metatarsal osteotomies to correct hallux valgus bunion indications
- Fractures of the fifth metatarsal bone in the foot
- Carpal bone fusions and fractures
Flatfoot Osteotomies:
- Lateral column lengthening (Evans osteotomy)
- Plantar flexion opening wedge osteotomy of the medial cuneiform (Cotton osteotomy)
- Medial displacement calcaneal osteotomy
Midfoot/Hindfoot Arthrodesis/Fusions
- Lisfranc arthrodesis and/or stabilization
- 1st, 2nd, 3rd and 4th Tarsometatarsal (TMT) fusions
- Navicular-Cuneiform (NC) joint fusions
- Talo-Navicular (TN) joint fusions
- Calcaneo-Cuboid (CC) joint fusions
- Medial column fusions (NC and 1st TMT)
The Trident Extremity Fixation System screws and plates are indicated for use with the Trident Plates and Screws of the same material. The locking and non-locking solid cortical screws, cannulated screws and headless screws are also indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171690 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171690: Trident Extremity Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171690
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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