510(k) · Cleared

Recalled · Class II · 2018

Trimed Osteotomy Plate

K043263510(k) TraditionalCleared Jan 14, 200551-day reviewClass II21 CFR 888.3030Recalls 1

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 14, 2005 as substantially equivalent to K952766 (Creative Medical Designs, Inc., 1995) and 1 other predicate after a 51-day review. Its family tree reaches back 1 generation to 1995. 11 later devices descend from it. It has been recalled once.

Decided: Jan 14, 2005
Review: 51 days
Class: Class II
Product code: HRS
Recalls: 1
Predicates: 2

Its longest line of descent runs back 1 generation to K952766 (1995). 2 ancestors in all. 11 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK952766 Rayhack Osteotomy System (Modification)Creative Medical Designs, Inc. · 1995
This deviceK043263 Trimed Osteotomy PlateTriMed, Inc. · 2005
Descendant · cites it directly · 5 of its ownK141232 Aptus Ulna Shortening 2.5Medartis AG · 2014 · Recalled
Descendant · 2 generations on · 1 of its ownK260390 Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026
Descendant · 2 generations on · 1 of its ownK211592 Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc. · 2021
Descendant · cites it directly · 1 of its ownK130008 Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol)…I.T.S. GmbH · 2013 · Recalled
Descendant · cites it directly · 0 of its ownK262649 Alians ForearmNewclip Technics · 2026

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2009high 5 (2026) · low 0 (2010)2026

Most influential descendants

Showing 5 of 11 · See all

K141232Aptus Ulna Shortening 2.5Medartis AG · 2014 · cites it directly5descendants
K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026 · 2 generations on1descendant
K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc. · 2021 · 2 generations on1descendant
K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH · 2013 · cites it directly1descendant
K262649Alians ForearmNewclip Technics · 2026 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K952766	Rayhack Osteotomy System (Modification)	Creative Medical Designs, Inc.	1995	—
0 (this device)	K043263	Trimed Osteotomy Plate	TriMed, Inc.	2005	—
+1	K141232	Aptus Ulna Shortening 2.5	Medartis AG	2014	1
+2	K260390	Super Upper Limbs Versalock Plating System	GM Dos Reis Industria e Comercio Ltda.	2026	—
+2	K211592	Avanti Orthopaedics Ulnar Shortening System	Avanti Orthopaedics, Inc.	2021	—
+1	K130008	Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0…	I.T.S. GmbH	2013	1
+1	K262649	Alians Forearm	Newclip Technics	2026	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2013	1	0
2014	1	0
2020	1	0
2021	1	0
2025	1	0
2026	5	0

FIG. 1 — Lineage of K043263, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K952766	Rayhack Osteotomy System (Modification) Summary page 1 …mber 22, 2004 Intended Use: The TriMed Unlar Osteotomny Plate is intended for use in osteotomy procedures of the ulna. Substantial Equivalence: K952766 Rayhack Osteotomy System K030310 Synthes 3.5/4.5 mm. LCP Metaphyseal Plates ZihlA(nld-er~s Regulatory Affairs Special…	Creative Medical Designs, Inc.	1995	—
*	K030310	Synthes Stainless Steel Modular Hand System Summary page 1 …e TriMed Unlar Osteotomny Plate is intended for use in osteotomy procedures of the ulna. Substantial Equivalence: K952766 Rayhack Osteotomy System K030310 Synthes 3.5/4.5 mm. LCP Metaphyseal Plates ZihlA(nld-er~s Regulatory Affairs Specialist DEPARTMENT OF…	Synthes (Usa)	2003	—

Also cleared against K952766: 1 other device →

What descends from it? (11)

See all 11

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

Number	Device	Applicant	Decided	Descendants
K141232	Aptus Ulna Shortening 2.5	Medartis AG	2014	5
K130008	Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…	I.T.S. GmbH	2013	1
K262649	Alians Forearm	Newclip Technics	2026	0
K250929	TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar…	TriMed, Inc.	2025	0
K091156	Trimed Sterile Product	TriMed, Inc.	2009	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 16, 2018	Class II	Z-2877-2018	Process control	Two instrument holes located on the side of the plate, which act to align the saw guide are located on the wrong side of the plate

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K141232 (Medartis AG, 2014) has gone furthest, with 5 descendants of its own.
1 other device also cites its predicate K952766.

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

2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007high 144 (2022) · low 57 (2014)2026

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

Recalls per year · HRS

1in 2025

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

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

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 Ulnar Osteotomy Plate is intended for use in osteotomy procedures of the ulna.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K043263 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043263: Trimed Osteotomy Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043263

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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