510(k) Report

510(k) · Cleared

Cleared

TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle Plates); TriMed Wrist Fixation System (Hook Plates); TriMed Wrist Fixation System (Pin Plates); TriMed Wrist Fixation System (Peg Plates); TriMed Wrist Fixation System (Shear Plates); TriMed Wrist Fixation System (Wireform plates and Washer); TriMed Wrist Fixation System (Wireforms); TriMed Wrist Fixation System (Torx Cortical Screws); TriMed Wrist Fixation System (Torx Threaded Pegs);

K243569510(k) TraditionalCleared Jan 15, 202558-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

TriMed, Inc. · HRS Plate, Fixation, Bone

Cleared on Jan 15, 2025 as substantially equivalent to K222637 (TriMed, Inc., 2022) after a 58-day review. Its family tree reaches back 3 generations to 1995.

Decided
Jan 15, 2025
Review
58 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K951303 (1995). 5 ancestors in all, the oldest K951302 (1995). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 1 other ancestor1995: 1 other ancestorK951303 · SFC · Medpac · 1995K010545 · TBW · Tri-Med, Inc. · 2001K222637 · TriMed Wrist Fixation System 3 · TriMed, Inc. · 2022 · recalled1995200020052010201520202025
Other ancestors, by generation 2 generations back: 2 other ancestors K222637 · TriMed Wrist Fixation System 3 · TriMed, Inc. · 2022 · recalledK010545 · TBW · Tri-Med, Inc. · 2001K951303 · SFC · Medpac · 19950
  1. Root · 3 generations backK951303 SFCMedpac · 1995
  2. 2 generations backK010545 TBWTri-Med, Inc. · 2001
  3. 1 generation backK222637 TriMed Wrist Fixation System 3TriMed, Inc. · 2022 · Recalled
  4. This deviceK243569 TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist…TriMed, Inc. · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K951303SFCMedpac1995—
−2K010545TBWTri-Med, Inc.2001—
−1K222637TriMed Wrist Fixation System 3TriMed, Inc.20221
0 (this device)K243569TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation…TriMed, Inc.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
200410
FIG. 1 — Lineage of K243569, 1995–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K222637TriMed Wrist Fixation System 3
Summary page 7
…Marketed Predicate Device(s) 21 CFR 807.92(a)(3) Device Trade Name: TriMed Wrist Fixation System 3 510(k) Number: K222637 Product Code: HRS Device Description 21 CFR 807.92(a)…
TriMed, Inc.20221

Also cleared against K222637: 2 other devices →

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 30 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
  • 2 of the 5 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K222637.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

What is it indicated for?

Specific indications for use of the subject devices in Wrist Fixation System are as follows: TriMed Volar Plates and Radial Peg Plates: 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: 1. Fractures of the radial column of the wrist. 2. Fractures of the dorsal ulnar cortex of the distal radius. TriMed Wire Forms, Shear Plates and Hook…

Read the full statement (144 words)

Specific indications for use of the subject devices in Wrist Fixation System are as follows:

TriMed Volar Plates and Radial Peg Plates:

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:

1. Fractures of the radial column of the wrist.

2. Fractures of the dorsal ulnar cortex of the distal radius.

TriMed Wire Forms, Shear Plates 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.

TriMed Radial Osteotomy System is indicated for osteotomies of the distal radius.

TriMed Welded Wire Forms in Wrist Fixation System 3 is indicated for 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.

Also cleared against K222637

2 other devices cite the same predicate.

  • K251732Wrist Fracture SystemMet One Technologies, LLC · 2026
  • K254002TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing…TriMed, Inc. · 2026

More from TriMed, Inc.

38 FDA decisions under this applicant name. See the company

  • K262344Large Compression ScrewsTriMed, Inc. · 2026
  • K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed…TriMed, Inc. · 2026
  • K261241TriMed Compression ScrewsTriMed, Inc. · 2026
  • K254002TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing…TriMed, Inc. · 2026
  • K252061Distal Xtremities SystemTriMed, Inc. · 2025

Recent decisions in HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K243569 · printed Nov 4, 2026

Cite this page

510(k) Report. “K243569: TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle Plates); TriMed Wrist Fixation System (Hook Plates); TriMed Wrist Fixation System (Pin Plates); TriMed Wrist Fixation System (Peg Plates); TriMed Wrist Fixation System (Shear Plates); TriMed Wrist Fixation System (Wireform plates and Washer); TriMed Wrist Fixation System (Wireforms); TriMed Wrist Fixation System (Torx Cortical Screws); TriMed Wrist Fixation System (Torx Threaded Pegs);.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K243569

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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