510(k) · Cleared

Cleared

SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, TAMlNA 3.5mm Proximal Humerus System, TRIFT 3.5mm 1/3 Tubular System

K203002510(k) TraditionalCleared Oct 5, 2021369-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

Bonebridge AG · HRS Plate, Fixation, Bone

Cleared on Oct 5, 2021 as substantially equivalent to K011335 (Synthes (Usa), 2001) after a 369-day review. Its family tree reaches back 2 generations to 2000. 9 later devices descend from it.

Decided: Oct 5, 2021
Review: 369 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K000684 (2000). 9 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 2 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
1 generation backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
This deviceK203002 SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior…Bonebridge AG · 2021
Descendant · cites it directly · 8 of its ownK213864 Bonebridge Osteosynthesis Plating SystemBonebridge AG · 2022
Descendant · 2 generations on · 7 of its ownK231292 TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal…Bonebridge AG · 2023
Descendant · 3 generations on · 4 of its ownK240318 SITTER 3.5mm Versatile SystemBonebridge AG · 2024
Descendant · cites it directly · 1 of its ownK250933 LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG · 2025
Descendant · 4 generations on · 1 of its ownK243308 Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal…Bonebridge AG · 2024

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2022high 3 (2024) · low 1 (2022)2026

Most influential descendants

Showing 5 of 9 · See all

K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG · 2022 · cites it directly8descendants
K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG · 2023 · 2 generations on7descendants
K240318SITTER 3.5mm Versatile SystemBonebridge AG · 2024 · 3 generations on4descendants
K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG · 2025 · cites it directly1descendant
K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG · 2024 · 4 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K000684	Small Fragment Dynamic Compression Locking (DCL) System	Synthes (Usa)	2000	1
−1	K011335	Synths One-Third Tubular DCL Plate	Synthes (Usa)	2001	2
0 (this device)	K203002	SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle…	Bonebridge AG	2021	—
+1	K213864	Bonebridge Osteosynthesis Plating System	Bonebridge AG	2022	—
+2	K231292	TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia…	Bonebridge AG	2023	—
+3	K240318	SITTER 3.5mm Versatile System	Bonebridge AG	2024	—
+1	K250933	LORRAINE 2.5/3.5mm Distal Humerus System	Bonebridge AG	2025	—
+4	K243308	Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System…	Bonebridge AG	2024	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2022	1	0
2023	1	0
2024	3	0
2025	2	0
2026	2	0

FIG. 1 — Lineage of K203002, 2000–2026Source: 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

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K011335	Synths One-Third Tubular DCL Plate Summary page 5 …is Plating System Primary predicate device TRIFT 3.5mm 1/3 Tubular System SYNTHES one-third tubular plate 3.5mm K011335 SYNTHS ONE-THIRD TUBULAR DCL PLATE INDICATIONS FOR USE The TRIFT 3.5mm 1/3 Tubular…	Synthes (Usa)	2001	2

Also cleared against K011335: 42 other devices →

What descends from it? (9)

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

Number	Device	Applicant	Decided	Descendants
K213864	Bonebridge Osteosynthesis Plating System	Bonebridge AG	2022	8
K250933	LORRAINE 2.5/3.5mm Distal Humerus System	Bonebridge AG	2025	1

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 21 years and passes through 2 companies; a new generation was cleared every 20.2 years on median.
2 of the 2 ancestors have a recall of any class.
Of its descendants, K213864 (Bonebridge AG, 2022) has gone furthest, with 8 descendants of its own.
42 other devices also cite its predicate K011335.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

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 TRIFT 3.5mm 1/3 Tubular Plate is indicated for:

* Treatment of smaller fractures of long bones such as humerus, fibula, and ulna

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K203002 · printed Nov 5, 2026

Cite this page

510(k) Report. “K203002: SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, TAMlNA 3.5mm Proximal Humerus System, TRIFT 3.5mm 1/3 Tubular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203002

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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