510(k) · Cleared
Recalled · Class II · 2023TriMed Wrist Fixation System 3
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 Dec 21, 2022 as substantially equivalent to K040112 (Tri-Med, Inc., 2004) and 3 other predicates after a 112-day review. Its family tree reaches back 2 generations to 1995. 3 later devices descend from it. It has been recalled once.
- Decided
- Dec 21, 2022
- Review
- 112 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 2 generations to K951303 (1995). 4 ancestors in all, the oldest K951302 (1995). 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK951303 SFCMedpac · 1995
- 1 generation backK010545 TBWTri-Med, Inc. · 2001
- This deviceK222637 TriMed Wrist Fixation System 3TriMed, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK251732 Wrist Fracture SystemMet One Technologies, LLC · 2026
- Descendant · cites it directly · 0 of its ownK254002 TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing…TriMed, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK243569 TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist…TriMed, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See all- K251732Wrist Fracture SystemMet One Technologies, LLC · 2026 · cites it directly0descendants
- K254002TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S)…TriMed, Inc. · 2026 · cites it directly0descendants
- K243569TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar…TriMed, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951303 | SFC | Medpac | 1995 | — |
| −1 | K010545 | TBW | Tri-Med, Inc. | 2001 | — |
| 0 (this device) | K222637 | TriMed Wrist Fixation System 3 | TriMed, Inc. | 2022 | — |
| +1 | K251732 | Wrist Fracture System | Met One Technologies, LLC | 2026 | — |
| +1 | K254002 | TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates… | TriMed, Inc. | 2026 | — |
| +1 | K243569 | TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation… | TriMed, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K040112 | Trimed Bearing Plate; Trimed Volar Bearing PlateSummary page 4…ion fastener Regulatory Class: II Product Codes: HRS, HWC, NDL, NDG Predicate Device: Primary Predicate K040112 – TriMed Bearing Plate / TriMed Volar Bearing Plate, TriMed, Inc. (USA) Additional… | 2004 |
| * | K951302 | Small Fragment Plates and ScrewsSummary page 4…TriMed Bearing Plate / TriMed Volar Bearing Plate, TriMed, Inc. (USA) Additional Predicate Devices K951302 – Small Fragment Plates and Screws, MEDPAC. (USA) K951303 – Small Fragment Clamp an… | 1995 |
| * | K951303 | SFCSummary page 4…Additional Predicate Devices K951302 – Small Fragment Plates and Screws, MEDPAC. (USA) K951303 – Small Fragment Clamp and Buttress, MEDPAC, (USA) K010545 – Tension Band Wires, Tr… | 1995 |
| * | K010545 | TBWSummary page 4…ews, MEDPAC. (USA) K951303 – Small Fragment Clamp and Buttress, MEDPAC, (USA) K010545 – Tension Band Wires, TriMed, (USA) K222637 Page 2 of 3 Device Description TriMed Volar Plates consist of anatom… | 2001 |
What descends from it? (3)
3 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 |
|---|---|---|---|---|
| Nov 28, 2023 | Class II | Z-0932-2024 | Labeling design | Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 21.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K251732 (Met One Technologies, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K040112.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
TriMed Volar Plates and Radial Peg Plates The following fracture configurations may be applicable for treatment using the TriMed Volar Plates and Radial Peg Plates: 1. Fractures, non-unions or osteotomies of the distal radius. TriMed Ulnar Peg Plates Fractures, non-unions and osteotomies of the distal end of the ulna. TriMed Pin Plates The following fracture configurations may be applicable for treatment using the TriMed Pin Plates: 1. Fractures of the…
Read the full statement (114 words)
TriMed Volar Plates and Radial Peg Plates
The following fracture configurations may be applicable for treatment using the TriMed Volar Plates and Radial Peg Plates:
1. Fractures, non-unions or osteotomies of the distal radius.
TriMed Ulnar Peg Plates
Fractures, non-unions and osteotomies of the distal end of the ulna.
TriMed Pin Plates
The following fracture configurations may be applicable for treatment using the TriMed Pin Plates:
1. Fractures of the radial column of the wrist.
2. Fractures of the dorsal ulnar cortex of the distal radius.
TriMed Wire Forms and Hook Plates
Fragments of the distal radius large enough to allow intraosseous support from the device with an adjacent stable cortex of cortical bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222637 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222637: TriMed Wrist Fixation System 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222637
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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