510(k) Report

510(k) · Cleared

Cleared

Bonebridge Osteosynthesis Plating System

K213864510(k) TraditionalCleared Sep 2, 2022266-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 Sep 2, 2022 as substantially equivalent to K203002 (Bonebridge AG, 2021) and 9 other predicates after a 266-day review. Its family tree reaches back 11 generations to 1996. 8 later devices descend from it.

Decided
Sep 2, 2022
Review
266 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
10

Its longest line of descent runs back 11 generations to K962616 (1996). 109 ancestors in all, the oldest K792022 (1979). 8 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2021: 1 other ancestor2015: 1 other ancestor2012: 1 other ancestor2011: 2 other ancestors2009: 5 other ancestors2008: 6 other ancestors2007: 4 other ancestors2005: 7 other ancestors2001: 9 other ancestors2010: 2 other ancestors2004: 7 other ancestors2000: 10 other ancestors1996: 7 other ancestors2006: 7 other ancestors2003: 4 other ancestors2002: 3 other ancestors1998: 4 other ancestors1999: 3 other ancestors1989: 2 other ancestors1995: 2 other ancestors1992: 1 other ancestor1991: 1 other ancestor1990: 1 other ancestor1994: 4 other ancestors1993: 2 other ancestors1979: 1 other ancestor1997: 1 other ancestor2025: 2 descendants cleared2023: 1 descendant cleared2024: 3 descendants cleared2026: 2 descendants clearedK962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998×3: 3 generations cleared close together, K023007 (2002), K030198 (2003), K032705 (2003) ×2: 2 generations cleared close together, K050932 (2005), K051735 (2005) K071563 · Peri-Loc Periarticular Locked Plating System · Smith & Nephew, Inc. · 2007K090675 · Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories · Smith & Nephew, Inc. · 2009K100776 · Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System · Synthes (Usa) · 2010K120070 · Synthes Variable Angle LCP Elbow System · Synthes USA · 2012 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 9 other ancestors2 generations back: 14 other ancestors3 generations back: 16 other ancestors4 generations back: 24 other ancestors5 generations back: 16 other ancestors6 generations back: 10 other ancestors7 generations back: 6 other ancestors8 generations back: 3 other ancestors 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant K120070 · Synthes Variable Angle LCP Elbow System · Synthes USA · 2012 · recalledK100776 · Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System · Synthes (Usa) · 2010K090675 · Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories · Smith & Nephew, Inc. · 2009K071563 · Peri-Loc Periarticular Locked Plating System · Smith & Nephew, Inc. · 2007K051735 · Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity · Smith & Nephew, Inc. · 2005K050932 · Distal Volar Radius Anatomical Plate System · Hand Innovations, Inc. · 2005 · recalledK032705 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K030198 · Hand Innovations, Inc. Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K023007 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2002K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998K962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996−10−50
  1. Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 7 generations between
  3. 3 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  4. 2 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
  5. 1 generation backK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
  6. This deviceK213864 Bonebridge Osteosynthesis Plating SystemBonebridge AG · 2022
  7. Descendant · cites it directly · 7 of its ownK231292 TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal…Bonebridge AG · 2023
  8. Descendant · 2 generations on · 4 of its ownK240318 SITTER 3.5mm Versatile SystemBonebridge AG · 2024
  9. Descendant · cites it directly · 1 of its ownK250933 LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG · 2025
  10. Descendant · 3 generations on · 1 of its ownK243308 Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal…Bonebridge AG · 2024
  11. Descendant · 2 generations on · 1 of its ownK242399 Bonebridge Osteosynthesis Plating SystemBonebridge AG · 2024
Show all 11 generations
  1. Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 10 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 9 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 8 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 7 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 6 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 5 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 4 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
  9. 3 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  10. 2 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
  11. 1 generation backK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
  12. This deviceK213864 Bonebridge Osteosynthesis Plating SystemBonebridge AG · 2022

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2023: 12024: 32025: 22026: 2
2023high 3 (2024) · low 1 (2023)2026

Most influential descendants

Showing 5 of 8 · See all
  • K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG · 2023 · cites it directly7descendants
  • K240318SITTER 3.5mm Versatile SystemBonebridge AG · 2024 · 2 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 · 3 generations on1descendant
  • K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG · 2024 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−10K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−9K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−8K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−7K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−6K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−5K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−4K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007—
−3K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009—
−2K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010—
−1K120070Synthes Variable Angle LCP Elbow SystemSynthes USA20121
0 (this device)K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG2022—
+1K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia…Bonebridge AG2023—
+2K240318SITTER 3.5mm Versatile SystemBonebridge AG2024—
+1K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG2025—
+3K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System…Bonebridge AG2024—
+2K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198920
199010
199110
199210
199320
199440
199520
199670
199710
199840
199930
2000100
200190
200230
200340
200470
200570
200670
200740
200860
200950
201020
201120
201210
201510
202110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
202430
202520
202620
FIG. 1 — Lineage of K213864, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (10)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K203002SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System…
Summary page 5
…TIVE INFORMATION Date prepared December 03, 2021 Submission type: Traditional 510(k) Purpose of 510(k): Modification of currently cleared device K203002 Line Extension Submitter Bonebridge AG Bahnhofstrasse 11…
Bonebridge AG2021—
*K142906APTUS Wrist 2.5 System
Summary page 6
…tal Radius Medartis APTUS 2.5 TriLock Distal Radius System Fracture Plate K142906, K051567 APTUS® Wrist 2.5 System CASCELLA 3.5mm Superior Clavicle SYNTHES LCP Superior Clavicle Plate 3.5mm System…
Medartis AG2015—
*K051567Aptus Titanium Osteosynthesis System
Summary page 6
…s Medartis APTUS 2.5 TriLock Distal Radius System Fracture Plate K142906, K051567 APTUS® Wrist 2.5 System CASCELLA 3.5mm Superior Clavicle SYNTHES LCP Superior Clavicle Plate 3.5mm System…
Medartis, Inc.20051
*K111540Synthes 3.5MM LCP Clavicle Plate System
Summary page 6
…567 APTUS® Wrist 2.5 System CASCELLA 3.5mm Superior Clavicle SYNTHES LCP Superior Clavicle Plate 3.5mm System K111540, K073186 Synthes 3.5mm LCP Clavicle Plate System TAMINA 3.5mm Proximal Humerus Sys…
Synthes (Usa)2011—
*K073186Synthes 3.5MM LCP Clavicle Plate System
Summary page 6
…® Wrist 2.5 System CASCELLA 3.5mm Superior Clavicle SYNTHES LCP Superior Clavicle Plate 3.5mm System K111540, K073186 Synthes 3.5mm LCP Clavicle Plate System TAMINA 3.5mm Proximal Humerus System…
Synthes (Usa)2007—
*K011815Synthes LCP Proximal Humerus Plates
Summary page 6
…m Proximal Humerus System SYNTHES PHILOS Proximal Humeral Plate 3.5mm K011815 Synthes LCP Proximal Humerous Plates (Standard) POYA 3.5mm Lateral Proximal Tibia…
Synthes (Usa)2001—
*K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate System
Summary page 6
…ibia SYNTHES 3.5 mm Variable Angle LCP Proximal System (POYA-L) Tibia Plate system K120689 SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM POYA 3.5mm Posteromedial Tibia S…
Synthes (USA) Products, LLC2012—
*K082624Synthes (Usa) 3.5MM LCP Posteromedial Proximal Tibia Plates
Summary page 6
…Posteromedial Tibia System SYNTHES 3.5mm LCP Posteromedial Tibia (POYA-P) Plate K082624 SYNTHES (USA) 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATES DALVAZZA 2.5mm Distal…
Synthes (Usa)2008—
*K092247Synthes Locking Hand Plates
Summary page 6
…POSTEROMEDIAL PROXIMAL TIBIA PLATES DALVAZZA 2.5mm Distal Ulna System SYNTHES 2.0mm LCP Distal Ulna Plate K092247 SYNTHES LOCKING HAND PLATES LEPORELLO 3.5mm Olecranon System SYNTHES VA-LCP Olecranon Plate…
Synthes (Usa)2009—
*K120070Synthes Variable Angle LCP Elbow System
Summary page 6
…K092247 SYNTHES LOCKING HAND PLATES LEPORELLO 3.5mm Olecranon System SYNTHES VA-LCP Olecranon Plate K120070 SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM INDICATIONS FOR USE The SALGINA® 2.5mm…
Synthes USA20121

Also cleared against K203002: 1 other device →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG20237
K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251

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 26 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
  • 23 of the 109 ancestors have a recall of any class.
  • Of its descendants, K231292 (Bonebridge AG, 2023) has gone furthest, with 7 descendants of its own.
  • 1 other device also cites its predicate K203002.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

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

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
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

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

What is it indicated for?

The SALGINA® 2.5mm Volar 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 TAMINA® and TAMINA®TF Proximal Humerus System is indicated for: * Dislocated…

Read the full statement (227 words)

The SALGINA® 2.5mm Volar 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 TAMINA® 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

The POYA® 3.5mm Lateral Proximal Tibia System is indicated for the internal fixation of fractures of the proximal tibia in adults and skeletally mature adolescents including:

* simple fractures

» comminuted fractures

» lateral wedge, medial wedge as well as bicondylar combination of lateral and medial wedge fractures

* depression fractures

» periprosthetic fractures

* nonunions, malunions, tibial osteotomies and osteopenic bone

The POYA® 3.5mm Posteromedial Tibia System is indicated for internal fixation of posteromedial proximal tibia fractures including buttressing of fractures of the proximal areas of the tibia.

The DALVAZZA® 2.5mm Distal Ulna System is indicated for

» fixation of fractures

* nonunions

of the distal ulna.

The LEPORELLO® 3.5mm Olecranon System is indicated for

» fractures

* osteotomies

* non-unions

of the olecranon and proximal ulna.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K203002

1 other device cites the same predicate.

  • K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG · 2025

More from Bonebridge AG

10 FDA decisions under this applicant name. See the company

  • K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG · 2026
  • K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG · 2026
  • K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG · 2025
  • K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG · 2025
  • K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior…Bonebridge AG · 2024

Recent decisions in HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K213864 · printed Nov 6, 2026

Cite this page

510(k) Report. “K213864: 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/K213864

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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