510(k) · Cleared
ClearedBonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste)
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 20, 2024 as substantially equivalent to K240318 (Bonebridge AG, 2024) and 7 other predicates after a 60-day review. Its family tree reaches back 14 generations to 1996. 1 later device descends from it.
- Decided
- Dec 20, 2024
- Review
- 60 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 14 generations to K962616 (1996). 126 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- 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 backK240318 SITTER 3.5mm Versatile SystemBonebridge AG · 2024
- This deviceK243308 Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal…Bonebridge AG · 2024
- Descendant · cites it directly · 0 of its ownK261351 SALGINA 2.5mm Distal Radius SystemBonebridge AG · 2026
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 backK240318 SITTER 3.5mm Versatile SystemBonebridge AG · 2024
- This deviceK243308 Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal…Bonebridge AG · 2024
Most influential descendants
Showing 1 of 1 · See all- K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG · 2026 · cites it directly0descendants
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 | K240318 | SITTER 3.5mm Versatile System | Bonebridge AG | 2024 | — |
| 0 (this device) | K243308 | Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System… | Bonebridge AG | 2024 | — |
| +1 | K261351 | SALGINA 2.5mm Distal Radius System | Bonebridge AG | 2026 | — |
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 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 7 | 0 |
| 1997 | 1 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 10 | 0 |
| 2001 | 10 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 8 | 0 |
| 2005 | 8 | 0 |
| 2006 | 8 | 0 |
| 2007 | 6 | 0 |
| 2008 | 8 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (8)
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 |
|---|---|---|---|
| * | K240318 | SITTER 3.5mm Versatile SystemSummary page 5…VE INFORMATION Date prepared October 21, 2024 Submission type: Traditional 510(k) Purpose of 510(k): Modification of currently cleared device K240318: Line extensions of the cleared SALGINA 2.5mm Distal Radius System, CASCELLA 3… | 2024 |
| * | K142906 | APTUS Wrist 2.5 SystemSummary page 6…Plating System (K240318) SALGINA 2.5mm Distal Radius System Additional predicate devices: SALGINA 2.5mm Distal Radius System K142906 APTUS Wrist 2.5 System (line extension) (volar plates)… | 2015 |
| * | K191848 | APTUS Wrist Spanning Plates 2.5Summary page 6…mm Distal Radius System K142906 APTUS Wrist 2.5 System (line extension) (volar plates) K191848 APTUS Wrist 2.5 System (wrist spanning plate)… | 2019 |
| * | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSummary page 6…K191848 APTUS Wrist 2.5 System (wrist spanning plate) K082807 Synthes (USA) 3.5mm Locking Compression Plate (LCP)… | 2008 |
| * | K102694 | 2.4MM VA-LCP Dorsal Distal Radius PlatesSummary page 6…Locking Compression Plate (LCP) System with Expanded Indications K102694 2.4mm Variable Angle LCP Dorsal Distal Radius System CASCELLA 3.5mm Superior Clav… | 2010 |
| * | K073186 | Synthes 3.5MM LCP Clavicle Plate SystemSummary page 6…K102694 2.4mm Variable Angle LCP Dorsal Distal Radius System CASCELLA 3.5mm Superior Clavicle K073186 Synthes 3.5mm LCP System (line extension) Clavicle Plate System… | 2007 |
| * | K000684 | Small Fragment Dynamic Compression Locking (DCL) SystemSummary page 6…Superior Clavicle K073186 Synthes 3.5mm LCP System (line extension) Clavicle Plate System K000684 Synthes Small Fragment Dynamic Compression Locking (DCL)… | 2000 |
| * | K120070 | Synthes Variable Angle LCP Elbow SystemSummary page 6…Dynamic Compression Locking (DCL) System LEPORELLO 3.5mm Olecranon K120070 Synthes Variable Angle LCP System (line extension) Elbow System / Olecranon Plates Bonebridge Osteosynth… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261351 | SALGINA 2.5mm Distal Radius System | 2026 | 0 |
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 28 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 28 of the 126 ancestors have a recall of any class.
- Of its descendants, K261351 (Bonebridge AG, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K240318.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 SALGINA 2.5mm Distal Radius System is indicated for
• Intra-articular fractures of the Distal Radius.
• Extra-articular fractures of the Distal Radius
The CASCELLA 3.5mm Superior Clavicle System is indicated for:
• fixation of fractures of the clavicle shaft
• fixation of fractures of the lateral clavicle
• malunions of the clavicle
• non-unions of the clavicle
The LEPORELLO 3.5mm Olecranon System is indicated for
• fractures
• osteotomies
• nonunions
of the olecranon and proximal ulna.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243308 · printed Nov 3, 2026
Cite this page
510(k) Report. “K243308: Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K243308
Report an extraction error
Are you the manufacturer?
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