510(k) Report

510(k) · Cleared

Cleared

Synthes VA LCP Ankle Trauma System

K120854510(k) TraditionalCleared Jun 18, 201289-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

Synthes USA · HRS Plate, Fixation, Bone

Cleared on Jun 18, 2012 as substantially equivalent to K033805 (Synthes (Usa), 2004) and 9 other predicates after an 89-day review. Its family tree reaches back 12 generations to 1996. 44 later devices descend from it.

Decided
Jun 18, 2012
Review
89 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
10

Its longest line of descent runs back 12 generations to K962616 (1996). 96 ancestors in all, the oldest K792022 (1979). 44 later devices descend from it, 9 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 3 other ancestors2008: 4 other ancestors2004: 7 other ancestors2001: 9 other ancestors2000: 9 other ancestors2010: 1 other ancestor2009: 3 other ancestors2007: 2 other ancestors2006: 7 other ancestors2005: 5 other ancestors2003: 5 other ancestors2002: 3 other ancestors1998: 3 other ancestors1996: 6 other ancestors1999: 3 other ancestors1992: 1 other ancestor1990: 1 other ancestor1994: 4 other ancestors1993: 2 other ancestors1979: 1 other ancestor1995: 2 other ancestors1991: 1 other ancestor1989: 1 other ancestor1997: 1 other ancestor2015: 3 descendants cleared2018: 4 descendants cleared2019: 4 descendants cleared2021: 7 descendants cleared2013: 1 descendant cleared2012: 1 descendant cleared2024: 3 descendants cleared2017: 2 descendants cleared2022: 2 descendants cleared2016: 2 descendants cleared2025: 4 descendants cleared2020: 4 descendants cleared2026: 7 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) · 2010×2: 2 generations cleared close together, K120070 (2012), K120717 (2012) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 18 other ancestors3 generations back: 13 other ancestors4 generations back: 12 other ancestors5 generations back: 16 other ancestors6 generations back: 11 other ancestors7 generations back: 4 other ancestors8 generations back: 1 other ancestor9 generations back: 1 other ancestor10 generations back: 1 other ancestor 1 generation forward: 9 descendants2 generations forward: 13 descendants3 generations forward: 7 descendants4 generations forward: 10 descendants5 generations forward: 2 descendants6 generations forward: 2 descendants7 generations forward: 1 descendant K120717 · Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates) · Synthes USA · 2012K120070 · 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+5
  1. Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 8 generations between
  3. 3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
  4. 2 generations backK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
  5. 1 generation backK120717 Synthes Variable Angle LCP Elbow System (Medical and Posterolateral…Synthes USA · 2012
  6. This deviceK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
  7. Descendant · cites it directly · 23 of its ownK143385 Acumed Ankle Plating SystemAcumed, LLC · 2015
  8. Descendant · 2 generations on · 15 of its ownK151886 Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC · 2015
  9. Descendant · 3 generations on · 14 of its ownK181113 CoLink™ Afx Plating SystemIn2bones USA, LLC · 2018
  10. Descendant · cites it directly · 8 of its ownK143061 Activ Ankle Locking Plating SystemNewclip Technics · 2015
  11. Descendant · 4 generations on · 6 of its ownK191535 CoLink® Mini Plating SystemIn2bones USA, LLC · 2019
Show all 12 generations
  1. Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 11 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 10 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 9 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 8 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 7 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 6 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 5 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
  9. 4 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  10. 3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
  11. 2 generations backK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
  12. 1 generation backK120717 Synthes Variable Angle LCP Elbow System (Medical and Posterolateral…Synthes USA · 2012
  13. This deviceK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012

Showing 5 of 44 descendants. See all descendants

Descendants cleared per year

2012: 12013: 12015: 32016: 22017: 22018: 42019: 42020: 42021: 72022: 22024: 32025: 42026: 7
2012high 7 (2021) · low 0 (2014)2026

Most influential descendants

Showing 5 of 44 · See all
  • K143385Acumed Ankle Plating SystemAcumed, LLC · 2015 · cites it directly23descendants
  • K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC · 2015 · 2 generations on15descendants
  • K181113CoLink™ Afx Plating SystemIn2bones USA, LLC · 2018 · 3 generations on14descendants
  • K143061Activ Ankle Locking Plating SystemNewclip Technics · 2015 · cites it directly8descendants
  • K191535CoLink® Mini Plating SystemIn2bones USA, LLC · 2019 · 4 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−11K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−10K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−9K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−8K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−7K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−6K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−5K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007—
−4K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009—
−3K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010—
−2K120070Synthes Variable Angle LCP Elbow SystemSynthes USA20121
−1K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal…Synthes USA2012—
0 (this device)K120854Synthes VA LCP Ankle Trauma SystemSynthes USA2012—
+1K143385Acumed Ankle Plating SystemAcumed, LLC2015—
+2K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC2015—
+3K181113CoLink™ Afx Plating SystemIn2bones USA, LLC2018—
+1K143061Activ Ankle Locking Plating SystemNewclip Technics2015—
+4K191535CoLink® Mini Plating SystemIn2bones USA, LLC2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198910
199010
199110
199210
199320
199440
199520
199660
199710
199830
199930
200090
200190
200230
200350
200470
200550
200670
200720
200840
200930
201010
201130

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
201530
201620
201720
201840
201940
202040
202170
202220
202430
202540
202670
FIG. 1 — Lineage of K120854, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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
*K033805Synthes (Usa) 3.5 / 4.5 MM LCP Metaphyseal Plates
Summary page 1
…fixation appliances and accessories. Product Code: HRS, HWC Predicate Device: Synthes 4.5/3.5 LCP Metaphyseal Plates (K033805) Synthes 2.7/3.5 LCP Lateral Distal Fibula Plates (K083213 & K073460) Synthes One-T…
Synthes (Usa)2004—
*K083213Synthes 2.7 MM/3.5 MM LCP Distal Fibula Plates
Summary page 1
…Product Code: HRS, HWC Predicate Device: Synthes 4.5/3.5 LCP Metaphyseal Plates (K033805) Synthes 2.7/3.5 LCP Lateral Distal Fibula Plates (K083213 & K073460) Synthes One-Third Tubular Plates (KOI 11335) 3.5mm Cortex Screws (KI 125…
Synthes (Usa)2008—
*K073460Synthes 2.7 MM/3.5 MM LCP Distal Fibula Plates
Summary page 1
…de: HRS, HWC Predicate Device: Synthes 4.5/3.5 LCP Metaphyseal Plates (K033805) Synthes 2.7/3.5 LCP Lateral Distal Fibula Plates (K083213 & K073460) Synthes One-Third Tubular Plates (KOI 11335) 3.5mm Cortex Screws (KI 12583)…
Synthes (Usa)2008—
*K011335Synths One-Third Tubular DCL PlateSynthes (Usa)20012
*K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011—
*K000684Small Fragment Dynamic Compression Locking (DCL) System
Summary page 1
…) Synthes One-Third Tubular Plates (KOI 11335) 3.5mm Cortex Screws (KI 12583) 3.5 mm Locking Screws (K000684) Synthes 2.7mm VA Locking Screws (K 100776) 4.5mm VA Curved Condylar Plate Set (KI…
Synthes (Usa)20001
*K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System
Summary page 1
…335) 3.5mm Cortex Screws (KI 12583) 3.5 mm Locking Screws (K000684) Synthes 2.7mm VA Locking Screws (K 100776) 4.5mm VA Curved Condylar Plate Set (KI 110354) 2.7/3.5mm VA-LCP Elbow System (K 12…
Synthes (Usa)2010—
*K1103544.5MM VA-LCP Curved Condylar Plate System
Summary page 1
…3.5 mm Locking Screws (K000684) Synthes 2.7mm VA Locking Screws (K 100776) 4.5mm VA Curved Condylar Plate Set (KI 110354) 2.7/3.5mm VA-LCP Elbow System (K 120070 and K120717) Device The Synthes Variable Angle…
Synthes USA20112
*K120070Synthes Variable Angle LCP Elbow System
Summary page 1
…Synthes 2.7mm VA Locking Screws (K 100776) 4.5mm VA Curved Condylar Plate Set (KI 110354) 2.7/3.5mm VA-LCP Elbow System (K 120070 and K120717) Device The Synthes Variable Angle LCP Ankle Trauma System contains plates that are Description:…
Synthes USA20121
*K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)
Cleared while this submission was under review
Summary page 1
…7mm VA Locking Screws (K 100776) 4.5mm VA Curved Condylar Plate Set (KI 110354) 2.7/3.5mm VA-LCP Elbow System (K 120070 and K120717) Device The Synthes Variable Angle LCP Ankle Trauma System contains plates that are Description: inte…
Synthes USA2012—

Also cleared against K033805: 6 other devices →

What descends from it? (44)

See all 44

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

NumberDeviceApplicantDecidedDescendants
K143385Acumed Ankle Plating SystemAcumed, LLC201523
K143061Activ Ankle Locking Plating SystemNewclip Technics20158
K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126
K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182
K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241
K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191
K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210
K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170
K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130

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 5 companies; a new generation was cleared every 1.6 years on median.
  • 22 of the 96 ancestors have a recall of any class.
  • Of its descendants, K143385 (Acumed, LLC, 2015) has gone furthest, with 23 descendants of its own.
  • 6 other devices also cite its predicate K033805.

How does its category compare?

All HRS devices

HRS 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

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 Synthes Variable Angle LCP Ankle Trauma System is intended for fixation of the ankle in adults and adolescents (12-21) in which the growth plates have fused, and particularly in osteopenic bone. Specifically, * Medial and Anteromedial 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, * Distal Tibia…

Read the full statement (122 words)

The Synthes Variable Angle LCP Ankle Trauma System is intended for fixation of the ankle in adults and adolescents (12-21) in which the growth plates have fused, and particularly in osteopenic bone. Specifically,

* Medial and Anteromedial 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,

* Distal Tibia T Plates and Distal Tibia L Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and

* 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 as stated in the FDA summary.

Also cleared against K033805

6 other devices cite the same predicate.

  • K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating SystemDePuy Synthes · 2024
  • K201229Intai Anatomic Locking Plate and Screw SystemIntai Technology Corporation · 2022
  • K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2018
  • K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA · 2012
  • K103332Aptus Ulna PlatesMedartis AG · 2011
  • K042598Periarticular Locking Plates and Screws, 2357 and 2359 SeriesZimmer, Inc. · 20041 recall

More from Synthes USA

9 FDA decisions under this applicant name. See the company

  • K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA · 2015
  • K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA · 2012
  • K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA · 2012
  • K120070Synthes Variable Angle LCP Elbow SystemSynthes USA · 20121 recall
  • K120083Set Screw for TI Trochanteric Fixation Nail (TFN)Synthes USA · 2012

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/K120854 · printed Nov 6, 2026

Cite this page

510(k) Report. “K120854: Synthes VA LCP Ankle Trauma System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120854

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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