510(k) · Cleared
ClearedBonebridge Osteosynthesis Plating 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 Oct 31, 2024 as substantially equivalent to K240318 (Bonebridge AG, 2024) and 6 other predicates after a 79-day review. Its family tree reaches back 14 generations to 1996. 1 later device descends from it.
- Decided
- Oct 31, 2024
- Review
- 79 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 14 generations to K962616 (1996). 134 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 deviceK242399 Bonebridge Osteosynthesis Plating SystemBonebridge AG · 2024
- Descendant · cites it directly · 0 of its ownK260228 POYA 3.5mm Medial Proximal Tibia 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 deviceK242399 Bonebridge Osteosynthesis Plating SystemBonebridge AG · 2024
Most influential descendants
Showing 1 of 1 · See all- K260228POYA 3.5mm Medial Proximal Tibia 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) | K242399 | Bonebridge Osteosynthesis Plating System | Bonebridge AG | 2024 | — |
| +1 | K260228 | POYA 3.5mm Medial Proximal Tibia 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 | 7 | 0 |
| 2004 | 9 | 0 |
| 2005 | 9 | 0 |
| 2006 | 8 | 0 |
| 2007 | 5 | 0 |
| 2008 | 10 | 0 |
| 2009 | 6 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2015 | 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? (7)
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 System Cleared while this submission was under review Summary page 6…ries Regulatory class: Class II Product Code: HRS PREDICATE DEVICES Primary predicate device: Bonebridge Osteosynthesis Plating System (K240318) SITTER 3.5mm Versatile System Additional predicate devices: POYA 3.5mm Posteromedial Tibia Sy… | 2024 |
| * | K082624 | Synthes (Usa) 3.5MM LCP Posteromedial Proximal Tibia PlatesSummary page 6…hesis Plating System (K240318) SITTER 3.5mm Versatile System Additional predicate devices: POYA 3.5mm Posteromedial Tibia System K082624 Synthes (USA) 3.5mm LCP Posteromedial Proximal Tibia Plates… | 2008 |
| * | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSummary page 6…stem K082624 Synthes (USA) 3.5mm LCP Posteromedial Proximal Tibia Plates K082807 Synthes (USA) 4.5 mm Locking Compression Plate (LCP) System with… | 2008 |
| * | K032269 | Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia PlatesSummary page 6…Compression Plate (LCP) System with Expanded Indications POYA 3.5mm Medial Proximal Tibia K032269 Synthes (USA) 3.5 LCP Medial System Proximal Tibia Plates SALTI 2.5/3.5mm Ankle System… | 2003 |
| * | K120854 | Synthes VA LCP Ankle Trauma SystemSummary page 6…l Tibia K032269 Synthes (USA) 3.5 LCP Medial System Proximal Tibia Plates SALTI 2.5/3.5mm Ankle System K120854 Synthes Variable Angle LCP Ankle Trauma System… | 2012 |
| * | K011335 | Synths One-Third Tubular DCL PlateSummary page 6…Compression Plate (LCP) System with Expanded Indications K011335 Synthes One-Third Tubular DCL Plate Bonebridge Osteosynthesis Plating System Lin… | 2001 |
| * | K231292 | TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Summary page 5…VE INFORMATION Date prepared October 21, 2024 Submission type: Traditional 510(k) Purpose of 510(k): Modification of currently cleared device K231292 Line extension of the cleared K231292 POYA 3.5mm Posteromedial Tibia System and… | 2023 |
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 |
|---|---|---|---|
| K260228 | POYA 3.5mm Medial Proximal Tibia 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.
- 27 of the 134 ancestors have a recall of any class.
- Of its descendants, K260228 (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?
POYA 3.5mm Posteromedial Tibia System The Bonebridge POYA 3.5mm Posteromedial Tibia System is intended for adult patients and indicated for internal fixation of posteromedial proximal tibia fractures, including buttressing of fractures of the proximal and metaphyseal areas of the tibia. Additionally, the longer plates are indicated for fractures extending to the tibial shaft. POYA 3.5mm Medial Proximal Tibia System The POYA 3.5mm Medial Proximal Tibia…
Read the full statement (237 words)
POYA 3.5mm Posteromedial Tibia System
The Bonebridge POYA 3.5mm Posteromedial Tibia System is intended for adult patients and indicated for internal fixation of posteromedial proximal tibia fractures, including buttressing of fractures of the proximal and metaphyseal areas of the tibia. Additionally, the longer plates are indicated for fractures extending to the tibial shaft.
POYA 3.5mm Medial Proximal Tibia System
The POYA 3.5mm Medial Proximal Tibia System is intended for adult patients and indicated to buttress metaphyseal fractures of the medial tibia plateau, split- type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. Also, for use in the fixation of osteopenic bone and fixation of nonunions and malunions of the medial proximal tibia.
SALTI 2.5/3.5mm Ankle System
The SALTI 2.5/3.5mm Ankle System is intended for fixation of the ankle in adult patients and particularly in osteopenic bone. Specifically,
* The Medial and Anterolateral Distal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia.
» The Posterior Distal Tibia Plate is intended to buttress partial articular fractures and bone fragments of the distal tibia.
* The Lateral Distal Fibula Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K242399 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242399: Bonebridge Osteosynthesis Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242399
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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