510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Trimed Bone Plates

K060041510(k) TraditionalCleared Feb 7, 200632-day reviewClass II21 CFR 888.3030Recalls 3

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 Feb 7, 2006 as substantially equivalent to K051735 (Smith & Nephew, Inc., 2005) after a 32-day review. Its family tree reaches back 7 generations to 1996. 26 later devices descend from it. It has been recalled 3 times.

Decided
Feb 7, 2006
Review
32 days
Class
Class II
Product code
HRS
Recalls
3
Predicates
2

Its longest line of descent runs back 7 generations to K962616 (1996). 28 ancestors in all, the oldest K890939 (1989). 26 later devices descend from it, 9 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 3 other ancestors2003: 1 other ancestor2001: 4 other ancestors2000: 5 other ancestors1999: 2 other ancestors1995: 1 other ancestor1991: 1 other ancestor1989: 1 other ancestor1998: 2 other ancestors1996: 1 other ancestor2009: 1 descendant cleared2025: 5 descendants cleared2017: 4 descendants cleared2011: 1 descendant cleared2014: 1 descendant cleared2022: 2 descendants cleared2016: 3 descendants cleared2021: 2 descendants cleared2024: 2 descendants cleared2026: 3 descendants cleared2018: 1 descendant cleared2019: 1 descendant clearedK962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998×2: 2 generations cleared close together, K023007 (2002), K030198 (2003) K032705 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003×2: 2 generations cleared close together, K050932 (2005), K051735 (2005) 1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 6 other ancestors3 generations back: 10 other ancestors4 generations back: 3 other ancestors6 generations back: 1 other ancestor7 generations back: 1 other ancestor 1 generation forward: 9 descendants2 generations forward: 7 descendants3 generations forward: 8 descendants4 generations forward: 2 descendants K051735 · Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity · Smith & Nephew, Inc. · 2005K050932 · Distal Volar Radius Anatomical Plate System · Hand Innovations, Inc. · 2005 · recalledK032705 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K030198 · Hand Innovations, Inc. Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K023007 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2002K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998K962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996−50
  1. Root · 7 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 6 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 5 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 4 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 3 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 2 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 1 generation backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. This deviceK060041 Trimed Bone PlatesTriMed, Inc. · 2006
  9. Descendant · cites it directly · 12 of its ownK141430 Variax Distal Radius Plating SystemStryker Leibinger GmbH & Co KG · 2014
  10. Descendant · cites it directly · 4 of its ownK212581 VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH · 2022
  11. Descendant · 2 generations on · 4 of its ownK162841 VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH · 2017
  12. Descendant · 2 generations on · 4 of its ownK161292 Distal Radius Plating SystemMiami Device Solutions, LLC · 2016
  13. Descendant · 3 generations on · 3 of its ownK191641 AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable…Industrias Medicas Sampedro S.A.S · 2019

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2009: 12011: 12014: 12016: 32017: 42018: 12019: 12021: 22022: 22024: 22025: 52026: 3
2009high 5 (2025) · low 0 (2010)2026

Most influential descendants

Showing 5 of 26 · See all
  • K141430Variax Distal Radius Plating SystemStryker Leibinger GmbH & Co KG · 2014 · cites it directly12descendants
  • K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH · 2022 · cites it directly4descendants
  • K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH · 2017 · 2 generations on4descendants
  • K161292Distal Radius Plating SystemMiami Device Solutions, LLC · 2016 · 2 generations on4descendants
  • K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S · 2019 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−6K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−5K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−4K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−3K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−2K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−1K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
0 (this device)K060041Trimed Bone PlatesTriMed, Inc.2006—
+1K141430Variax Distal Radius Plating SystemStryker Leibinger GmbH & Co KG2014—
+1K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH2022—
+2K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH2017—
+2K161292Distal Radius Plating SystemMiami Device Solutions, LLC2016—
+3K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle…Industrias Medicas Sampedro S.A.S2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199110
199510
199610
199820
199920
200050
200140
200310
200430

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201110
201410
201630
201740
201810
201910
202120
202220
202420
202550
202630
FIG. 1 — Lineage of K060041, 1996–2026Source: 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? (2)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
Kept off the family treeK013655FDA’s K013655 is Nxstage Dialysate Concentrate, Model RFC-100
Our reading of the summary gave K013655, FDA’s number for Nxstage Dialysate Concentrate, Model RFC-100 (Nxstage Medical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Acumed Congruent Bone Plate System”. Kept off the family tree.
Summary page 1
…es used in the fixation of small and long bone fractures. The plates and screws are all made of stainless steel. IlL. Substantial Equivalence: K013655 Acumed Congruent Bone Plate System K051735 Smith & Nephew PERI-LOC Re ZAnddersonlv Regulatory Affairs Specialist ===…
Nxstage Medical, Inc.2002—
*K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity
Summary page 1
…bone fractures. The plates and screws are all made of stainless steel. IlL. Substantial Equivalence: K013655 Acumed Congruent Bone Plate System K051735 Smith & Nephew PERI-LOC Re ZAnddersonlv Regulatory Affairs Specialist DEPARTMENTOFBIE…
Smith & Nephew, Inc.2005—

Also cleared against K051735: 17 other devices →

What descends from it? (26)

See all 26

9 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K141430Variax Distal Radius Plating SystemStryker Leibinger GmbH & Co KG201412
K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224
K243999TriMed Ankle Fixation SystemTriMed, Inc.20252
K243987TriMed Elbow and Forearm SystemTriMed, Inc.20251
K170843Alians Fragment SpecificNewclip Technics20171
K213214Xpert WristNewclip Technics20210
K151735TriMed Humeral Supracondylar Fixation SystemTriMed, Inc.20160
K101930Memometal Navis Bone Plating SystemMemometal Technologies20110
K091156Trimed Sterile ProductTriMed, Inc.20090

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 24, 2018Class IIZ-1214-2019Component design/selectionThe bone screw is shorter than the intended design specification.
Aug 15, 2018Class IIZ-0366-2020Employee errorThe firm has become aware that the angled-hole of certain semi-tubular design bone plates may have been modified from its specification, and the modification may not have been fully qualified.
Aug 29, 2016Class IIZ-2849-2016Device DesignTriMed is recalling the Semi-Tubular Plates with 10 holes (SMTP-10) because a non-locking screw passed through a hole in a SMTP-10 plate being implanted.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 10 years and passes through 5 companies; a new generation was cleared every 7 months on median.
  • 7 of the 28 ancestors have a recall of any class.
  • Of its descendants, K141430 (Stryker Leibinger GmbH & Co KG, 2014) has gone furthest, with 12 descendants of its own.
  • 17 other devices also cite its predicate K051735.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

The TriMed Bone Plates are intended for use in the fixation of fractures to the Tibia, Fibula, Ulna, Radius and the Humerus.

Indications for use as stated in the FDA summary.

Also cleared against K051735

17 other devices cite the same predicate.

  • K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip…Smith & Nephew, Inc. · 20221 recall
  • K210837Smith & Nephew Plates and ScrewsSmith & Nephew, Inc. · 20211 recall
  • K141493Proximal Humerus Plating SystemMiami Device Solutions · 20151 recall
  • K140357Oic Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company · 2014
  • K132296D-Rad Smart PackSmith & Nephew, Inc. · 20144 recalls
  • K131636Polarus ConnectAcumed, LLC · 2013

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/K060041 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060041: Trimed Bone Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060041

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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