510(k) · Cleared
ClearedTriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate), TriMed ASET Foot Plating System (H-Plate), TriMed ASET Foot Plating System (Talonavicular Plate), TriMed ASET Foot Plating System (Calcaneal Slide Osteotomy Plate), TriMed ASET Foot Plating System (Evans Osteotomy Plate), TriMed ASET Foot Plating System (Medial Column Fusion Plate), TriMed ASET Foot Plating System (Straight Plate), TriMed ASET Foot Plating System (T-
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
TriMed, Inc. · HRS Plate, Fixation, Bone
Cleared on Apr 17, 2024 as substantially equivalent to K192696 (TriMed, Inc., 2020) and 2 other predicates after a 133-day review. Its family tree reaches back 14 generations to 1996.
- Decided
- Apr 17, 2024
- Review
- 133 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K954385 (1996). 70 ancestors in all, the oldest K895117 (1990). No later device cites it as a predicate yet.
- Root · 14 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 10 generations between
- 3 generations backK151442 Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc · 2015
- 2 generations backK152974 ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc · 2015
- 1 generation backK192696 TriMed ASET Foot Plating SystemTriMed, Inc. · 2020
- This deviceK233863 TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed…TriMed, Inc. · 2024
Show all 14 generations
- Root · 14 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
- 13 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
- 12 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
- 11 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
- 10 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
- 9 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
- 8 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
- 7 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
- 6 generations backK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
- 5 generations backK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
- 4 generations backK143025 Total Compression Plating SystemWrightmedicaltechnologyinc · 2014
- 3 generations backK151442 Total Compression Plating (TCP) SystemWrightmedicaltechnologyinc · 2015
- 2 generations backK152974 ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc · 2015
- 1 generation backK192696 TriMed ASET Foot Plating SystemTriMed, Inc. · 2020
- This deviceK233863 TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed…TriMed, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K954385 | Synthes Mandibular Modular Fixation System | Synthes (Usa) | 1996 | — |
| −13 | K974555 | Synthes 2.0 MM Locking Plate System (2.0 LPS) | Synthes (Usa) | 1998 | — |
| −12 | K030448 | Osteomed 2.0 Locking Plates and Screws | Osteomed LP | 2003 | — |
| −11 | K032442 | KLS-Martin Mandibular/Reconstruction System II | KLS-Martin L.P. | 2003 | — |
| −10 | K040598 | KLS Martin Hand Plating System | KLS-Martin L.P. | 2004 | — |
| −9 | K050868 | Maxlock | Orthohelix Surgical Designs, Inc. | 2005 | — |
| −8 | K073624 | Modular Foot System | Orthohelix Surgical Designs, Inc. | 2008 | 1 |
| −7 | K100618 | Maxlock Extreme Extremity Plating System with Variable Angle Technology | Orthohelix Surgical Designs, Inc. | 2010 | — |
| −6 | K113014 | Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws | Wrightmedicaltechnologyinc | 2012 | 12 |
| −5 | K121651 | Ortholoc 3DI Midfoot/Flatfoot System | Wrightmedicaltechnologyinc | 2012 | — |
| −4 | K143025 | Total Compression Plating System | Wrightmedicaltechnologyinc | 2014 | — |
| −3 | K151442 | Total Compression Plating (TCP) System | Wrightmedicaltechnologyinc | 2015 | — |
| −2 | K152974 | ORTHOLOC® 3Di Foot Plating Reconstruction System | Wrightmedicaltechnologyinc | 2015 | — |
| −1 | K192696 | TriMed ASET Foot Plating System | TriMed, Inc. | 2020 | — |
| 0 (this device) | K233863 | TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot… | TriMed, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 6 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 5 | 0 |
| 2010 | 6 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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 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? (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 |
|---|---|---|---|
| * | K192696 | TriMed ASET Foot Plating SystemSummary page 6…ber 888.3030 Product Code HRS | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K192696 TriMed ASET Foot Plating System HRS K222194 Baby Gorilla/Gorilla Plating System HRS K072740 Mondeal Extremity Bone Fixation Syste… | 2020 |
| * | K222194 | Baby Gorilla®/Gorilla® Plating SystemSummary page 6…keted Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K192696 TriMed ASET Foot Plating System HRS K222194 Baby Gorilla/Gorilla Plating System HRS K072740 Mondeal Extremity Bone Fixation System HRS Device Description Summary 21 CFR 807.… | 2022 |
| * | K072740 | Mondeal Extremity Bone Fixation SystemSummary page 6…icate # Predicate Trade Name (Primary Predicate is listed first) Product Code K192696 TriMed ASET Foot Plating System HRS K222194 Baby Gorilla/Gorilla Plating System HRS K072740 Mondeal Extremity Bone Fixation System HRS Device Description Summary 21 CFR 807.92(a)(4) The TriMed ASET Foot Plating System is… | 2007 |
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 28 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 17 of the 70 ancestors have a recall of any class.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 TriMed ASET™ Foot Plating System is indicated for use in stabilization of fractures, revision procedures, joint fusions, reconstructions, deformity corrections, osteotomies, and non-unions of small bones of the feet. Specific examples include: First metatarsal osteotomies for hallux valgus and hallux varus correction including: Opening/Closing base wedge osteotomies, Distal and Proximal Chevron osteotomies, Ludloff Osteotomy, Arthrodesis of the first…
Read the full statement (171 words)
The TriMed ASET™ Foot Plating System is indicated for use in stabilization of fractures, revision procedures, joint fusions, reconstructions, deformity corrections, osteotomies, and non-unions of small bones of the feet.
Specific examples include:
First metatarsal osteotomies for hallux valgus and hallux varus correction including:
Opening/Closing base wedge osteotomies, Distal and Proximal Chevron osteotomies, Ludloff Osteotomy,
Arthrodesis of the first metatarsophalangeal joint (MTP) including:
Primary MTP Fusion due to hallux rigidus and/or hallux valgus,
Revision MTP Fusion
Revision of failed first MTP Arthroplasty implant
Metatarsal and Phalanges:
Metatarsal and Phalanges fractures and osteotomies;
Mid / Hindfoot Fractures:
Cuneiform Fracture, Cuboid Fracture, Navicular Fracture
Mid / Hindfoot Fusions:
Tarsometatarsal (TMT) Fusions/Stabilization, Intercuneiform Fusions, Navicular Cuneiform (NC) Fusion, Talonavicular (TN) Fusion, Calcaneocuboid (CC) Fusion, Medial Column Fusion, Medial Column Fusion (talus, navicular, cuneiform, metatarsal) for neuropathic osteoarthropathy (Charcot), Lateral Column Fusion (calcaneus, cuboid, metatarsal) for neuropathic osteoarthropathy (Charcot)
Mid / Hindfoot Osteotomies (Deformity Corrections):
Lateral Column Lengthening (Evans Osteotomy), Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy), Medial Displacement Calcaneal Osteotomy
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K233863 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233863: TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate), TriMed ASET Foot Plating System (H-Plate), TriMed ASET Foot Plating System (Talonavicular Plate), TriMed ASET Foot Plating System (Calcaneal Slide Osteotomy Plate), TriMed ASET Foot Plating System (Evans Osteotomy Plate), TriMed ASET Foot Plating System (Medial Column Fusion Plate), TriMed ASET Foot Plating System (Straight Plate), TriMed ASET Foot Plating System (T-.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233863
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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