510(k) · Cleared
ClearedSynthes 3.5 MM VA-LCP Proximal Tibia Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (USA) Products, LLC · HRS Plate, Fixation, Bone
Cleared on Jun 4, 2012 as substantially equivalent to K011978 (Synthes (Usa), 2001) and 3 other predicates after a 90-day review. Its family tree reaches back 8 generations to 1996. 28 later devices descend from it.
- Decided
- Jun 4, 2012
- Review
- 90 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K962616 (1996). 38 ancestors in all, the oldest K890939 (1989). 28 later devices descend from it, 8 citing it directly.
- Root · 8 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 7 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 6 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 5 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 4 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 3 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 2 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 1 generation backK083286 Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp. · 2009 · Recalled
- This deviceK120689 Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC · 2012
- Descendant · cites it directly · 8 of its ownK213864 Bonebridge Osteosynthesis Plating SystemBonebridge AG · 2022
- Descendant · cites it directly · 7 of its ownK231292 TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal…Bonebridge AG · 2023
- Descendant · cites it directly · 7 of its ownK141527 Depuy Synthes Variable Angle Locking Hand SystemSynthes USA · 2015
- Descendant · cites it directly · 6 of its ownK162124 Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension…DePuy Synthes · 2017
- Descendant · 2 generations on · 4 of its ownK240318 SITTER 3.5mm Versatile SystemBonebridge AG · 2024
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · 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 · cites it directly7descendants
- K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA · 2015 · cites it directly7descendants
- K162124Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle…DePuy Synthes · 2017 · cites it directly6descendants
- K240318SITTER 3.5mm Versatile SystemBonebridge AG · 2024 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −7 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −6 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −5 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −4 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −3 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −2 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −1 | K083286 | Orthopediatrics Pediloc Locking Plate System | OrthoPediatrics Corp. | 2009 | 5 |
| 0 (this device) | K120689 | Synthes 3.5 MM VA-LCP Proximal Tibia Plate System | Synthes (USA) Products, LLC | 2012 | — |
| +1 | K213864 | Bonebridge Osteosynthesis Plating System | Bonebridge AG | 2022 | — |
| +1 | K231292 | TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia… | Bonebridge AG | 2023 | — |
| +1 | K141527 | Depuy Synthes Variable Angle Locking Hand System | Synthes USA | 2015 | — |
| +1 | K162124 | Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable… | DePuy Synthes | 2017 | — |
| +2 | K240318 | SITTER 3.5mm Versatile System | Bonebridge AG | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 7 | 0 |
| 2001 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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? (4)
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 |
|---|---|---|---|
| * | K011978 | Synthes LCP Proximal Tibia Plate | 2001 |
| * | K052390 | Synthes LCP Proximal Tibia Plates Line ExtensionSummary page 1…appliances and accessories.) Predicate Devices: Synthes 4.5mm LCP Proximal Tibia Plate KOI 1978 Synthes LCP Proximal Tibia Plate K052390 Synthes Large Fragment Dynamic Compression Locking (DCL) System K000682… | 2005 |
| * | K000682 | Synthes Large Fragment Dynamic Compression Locking (DCL) SystemSummary page 1…Synthes LCP Proximal Tibia Plate K052390 Synthes Large Fragment Dynamic Compression Locking (DCL) System K000682 Orthoediatrics PediL-o T Locking Plate Syste m K083286 Device Description: The Synthies 3.5 mm VA-LC… | 2000 |
| * | K083286 | Orthopediatrics Pediloc Locking Plate SystemSummary page 1…Synthes Large Fragment Dynamic Compression Locking (DCL) System K000682 Orthoediatrics PediL-o T Locking Plate Syste m K083286 Device Description: The Synthies 3.5 mm VA-LCP Proximal Tibia Plate System consists of pre-contoured… | 2009 |
What descends from it? (28)
See all 288 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213864 | Bonebridge Osteosynthesis Plating System | 2022 | 8 |
| K231292 | TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE… | 2023 | 7 |
| K141527 | Depuy Synthes Variable Angle Locking Hand System | 2015 | 7 |
| K162124 | Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle… | 2017 | 6 |
| K190391 | TDM Plate and Screw Systems | 2019 | 1 |
| K250155 | Xpert Knee | 2025 | 0 |
| K201917 | Piccolo Composite Proximal Tibia Plate System | 2020 | 0 |
| K160553 | DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist… | 2017 | 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 16 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 8 of the 38 ancestors have a recall of any class.
- Of its descendants, K213864 (Bonebridge AG, 2022) has gone furthest, with 8 descendants of its own.
- 15 other devices also cite its predicate K011978.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Synthes 3.5 mm VA-LCP Proximal Tibia Plates are intended to treat fractures of the proximal tibia in adults and adolescents in which the growth plates have fused including: simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of* lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures. Plates can also be used for treatment of nonunions, malunions, tibial osteotomies and osteopenic bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120689 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120689: Synthes 3.5 MM VA-LCP Proximal Tibia Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120689
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