510(k) · Cleared
ClearedBRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bonebridge AG · HRS Plate, Fixation, Bone
Cleared on Dec 17, 2025 as substantially equivalent to K250933 (Bonebridge AG, 2025) and 5 other predicates after a 156-day review. Its family tree reaches back 14 generations to 1996.
- Decided
- Dec 17, 2025
- Review
- 156 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 14 generations to K962616 (1996). 146 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 10 generations between
- 3 generations backK213864 Bonebridge Osteosynthesis Plating SystemBonebridge AG · 2022
- 2 generations backK231292 TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal…Bonebridge AG · 2023
- 1 generation backK250933 LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG · 2025
- This deviceK252191 BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG · 2025
Show all 14 generations
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 13 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 12 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 11 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 10 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 9 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 8 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 7 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 6 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 5 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 4 generations backK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
- 3 generations backK213864 Bonebridge Osteosynthesis Plating SystemBonebridge AG · 2022
- 2 generations backK231292 TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal…Bonebridge AG · 2023
- 1 generation backK250933 LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG · 2025
- This deviceK252191 BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −13 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −12 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −11 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −10 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −9 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −8 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −7 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −6 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −5 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −4 | K120070 | Synthes Variable Angle LCP Elbow System | Synthes USA | 2012 | 1 |
| −3 | 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 | — |
| −1 | K250933 | LORRAINE 2.5/3.5mm Distal Humerus System | Bonebridge AG | 2025 | — |
| 0 (this device) | K252191 | BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System | Bonebridge AG | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 3 | 0 |
| 1996 | 11 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 10 | 0 |
| 2001 | 11 | 0 |
| 2002 | 6 | 0 |
| 2003 | 7 | 0 |
| 2004 | 9 | 0 |
| 2005 | 10 | 0 |
| 2006 | 9 | 0 |
| 2007 | 5 | 0 |
| 2008 | 9 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 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? (6)
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 |
|---|---|---|---|
| * | K250933 | LORRAINE 2.5/3.5mm Distal Humerus SystemSummary page 6…K252191 - Page 2 of 5 PREDICATE DEVICES Primary predicate device: Bonebridge Osteosynthesis Plating System K250933 TAMINA 3.5mm Proximal Humerus System Subject Device: Additional predicate devices: BRUSIO Trauma Toolbo… | 2025 |
| * | K233665 | DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…Summary page 6…K250933 TAMINA 3.5mm Proximal Humerus System Subject Device: Additional predicate devices: BRUSIO Trauma Toolbox System K233665 Synthes VOLT Mini Fragment Plating System K063049… | 2024 |
| * | K063049 | Synthes (Usa) Modular Mini Fragment LCP SystemSummary page 6…BRUSIO Trauma Toolbox System K233665 Synthes VOLT Mini Fragment Plating System K063049 Synthes (USA) Modular Mini Fragment LCP System TAMINA 3.5mm Proximal Humerus K04… | 2006 |
| * | K041860 | Synthes (Usa) LCP Proximal Humerus Plates, LongSummary page 6…K063049 Synthes (USA) Modular Mini Fragment LCP System TAMINA 3.5mm Proximal Humerus K041860 Synthes (USA) LCP® System Proximal Humerus Plates, Long K0… | 2004 |
| * | K011815 | Synthes LCP Proximal Humerus PlatesSummary page 6…INA 3.5mm Proximal Humerus K041860 Synthes (USA) LCP® System Proximal Humerus Plates, Long K011815 Synthes LCP Proximal Humerus Plates K082807 Synthes… | 2001 |
| * | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSummary page 6…es, Long K011815 Synthes LCP Proximal Humerus Plates K082807 Synthes (USA) 3.5 mm Locking Compression Plate (LCP)… | 2008 |
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 29 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 26 of the 146 ancestors have a recall of any class.
How does its category compare?
All HRS devicesHRS 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
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?
The BRUSIO Trauma Toolbox System is indicated for internal fixation of fractures, osteotomies and nonunions of bones and bone fragments of the appendicular skeleton that are appropriate for the implant size in adult patients. When used in the clavicle, scapula, humerus, olecranon, pelvis, femur, tibia or fibula, the BRUSIO Trauma Toolbox System is intended only for non-load-bearing stabilization and reduction. The TAMINA, TAMINA Long and TAMINA TF…
Read the full statement (103 words)
The BRUSIO Trauma Toolbox System is indicated for internal fixation of fractures, osteotomies and nonunions of bones and bone fragments of the appendicular skeleton that are appropriate for the implant size in adult patients. When used in the clavicle, scapula, humerus, olecranon, pelvis, femur, tibia or fibula, the BRUSIO Trauma Toolbox System is intended only for non-load-bearing stabilization and reduction.
The TAMINA, TAMINA Long and TAMINA TF Proximal Humerus System is indicated for
• Dislocated two-, three-, and four fragment fractures of the proximal humerus including fractures involving osteopenic bone
• Pseudarthroses (non-unions) of the proximal humerus
• Osteotomies of the proximal humerus
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252191 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252191: BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252191
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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