510(k) · Cleared
ClearedSynthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes USA · HRS Plate, Fixation, Bone
Cleared on Jul 6, 2012 as substantially equivalent to K120854 (Synthes USA, 2012) and 11 other predicates after a 35-day review. Its family tree reaches back 13 generations to 1996. 6 later devices descend from it.
- Decided
- Jul 6, 2012
- Review
- 35 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 12
Its longest line of descent runs back 13 generations to K962616 (1996). 104 ancestors in all, the oldest K792022 (1979). 6 later devices descend from it, 4 citing it directly.
- Root · 13 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 9 generations between
- 3 generations backK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
- 2 generations backK120717 Synthes Variable Angle LCP Elbow System (Medical and Posterolateral…Synthes USA · 2012
- 1 generation backK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
- This deviceK121601 Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma…Synthes USA · 2012
- Descendant · cites it directly · 2 of its ownK171320 ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION…Meril Healthcare Pvt., Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK241599 Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK200062 Foot and Ankle SystemLeith Medical, LLC · 2021
- Descendant · 2 generations on · 0 of its ownK200701 Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK160553 DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2017
Show all 13 generations
- Root · 13 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 12 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 11 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 10 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 9 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 8 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 7 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 6 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 5 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 4 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 3 generations backK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
- 2 generations backK120717 Synthes Variable Angle LCP Elbow System (Medical and Posterolateral…Synthes USA · 2012
- 1 generation backK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
- This deviceK121601 Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma…Synthes USA · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd. · 2018 · cites it directly2descendants
- K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd. · 2025 · 2 generations on0descendants
- K200062Foot and Ankle SystemLeith Medical, LLC · 2021 · cites it directly0descendants
- K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc. · 2020 · 2 generations on0descendants
- K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −12 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −11 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −10 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −9 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −8 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −7 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −6 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −5 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −4 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −3 | K120070 | Synthes Variable Angle LCP Elbow System | Synthes USA | 2012 | 1 |
| −2 | K120717 | Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal… | Synthes USA | 2012 | — |
| −1 | K120854 | Synthes VA LCP Ankle Trauma System | Synthes USA | 2012 | — |
| 0 (this device) | K121601 | Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal… | Synthes USA | 2012 | — |
| +1 | K171320 | ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws… | Meril Healthcare Pvt., Ltd. | 2018 | — |
| +2 | K241599 | Signature Osteosynthesis Plate System | Signature Orthopaedic Pty, Ltd. | 2025 | — |
| +1 | K200062 | Foot and Ankle System | Leith Medical, LLC | 2021 | — |
| +2 | K200701 | Skeletal Dynamics Midshaft Humerus Plating System | Skeletal Dynamics, Inc. | 2020 | — |
| +1 | K160553 | DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes… | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 6 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 9 | 0 |
| 2001 | 10 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 10 | 0 |
| 2005 | 8 | 0 |
| 2006 | 7 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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? (12)
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 |
|---|---|---|---|
| * | K120854 | Synthes VA LCP Ankle Trauma System Cleared while this submission was under review Summary page 1…fixation appliances and accessories. Product Code: HRS, HWC Predicate Device: Synthes 2.7/3.5 VA-LCP Ankle Trauma System (K 120854) Synthes 4.513.5 LCP Metaphyseal Plates (K033805) Zimmer Periarticular and ECT Plate… | 2012 |
| * | K033805 | Synthes (Usa) 3.5 / 4.5 MM LCP Metaphyseal PlatesSummary page 1…Product Code: HRS, HWC Predicate Device: Synthes 2.7/3.5 VA-LCP Ankle Trauma System (K 120854) Synthes 4.513.5 LCP Metaphyseal Plates (K033805) Zimmer Periarticular and ECT Plate Systems (K040593, K042598, K043227, K043560, K030… | 2004 |
| * | K040593 | Periarticular Locking Plates and Screws, 2358, 2359 SeriesSummary page 1…P Ankle Trauma System (K 120854) Synthes 4.513.5 LCP Metaphyseal Plates (K033805) Zimmer Periarticular and ECT Plate Systems (K040593, K042598, K043227, K043560, K030121, K05 1098, and Pre-amendment) 3.5mm Cortex Screws… | 2004 |
| * | K042598 | Periarticular Locking Plates and Screws, 2357 and 2359 SeriesSummary page 1…rauma System (K 120854) Synthes 4.513.5 LCP Metaphyseal Plates (K033805) Zimmer Periarticular and ECT Plate Systems (K040593, K042598, K043227, K043560, K030121, K05 1098, and Pre-amendment) 3.5mm Cortex Screws (KI 1258… | 2004 |
| * | K043227 | Periarticular Locking Plates, 2358 SeriesSummary page 1…tem (K 120854) Synthes 4.513.5 LCP Metaphyseal Plates (K033805) Zimmer Periarticular and ECT Plate Systems (K040593, K042598, K043227, K043560, K030121, K05 1098, and Pre-amendment) 3.5mm Cortex Screws (KI 12583)… | 2004 |
| * | K043560 | Periarticular Locking Plates and Screws, Series 2358 and 2359Summary page 1…Synthes 4.513.5 LCP Metaphyseal Plates (K033805) Zimmer Periarticular and ECT Plate Systems (K040593, K042598, K043227, K043560, K030121, K05 1098, and Pre-amendment) 3.5mm Cortex Screws (KI 12583) 3.5 mm Locking… | 2005 |
| * | K050121 | Zimmer Periarticular Locking Plate System, Model 2357 & 2359 Our reading of the summary gave K030121, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Zimmer Periarticular and ECT Plate Systems”. | 2005 |
| * | K051098 | Periarticular Locking Plates and Screws, Model 2358 SeriesSummary page 1…3.5 LCP Metaphyseal Plates (K033805) Zimmer Periarticular and ECT Plate Systems (K040593, K042598, K043227, K043560, K030121, K05 1098, and Pre-amendment) 3.5mm Cortex Screws (KI 12583) 3.5 mm Locking Screws (K000684)… | 2005 |
| * | K112583 | Synthes Cortical Screws | 2011 |
| * | K000684 | Small Fragment Dynamic Compression Locking (DCL) SystemSummary page 1…7, K043560, K030121, K05 1098, and Pre-amendment) 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 (K] 10… | 2000 |
| * | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSummary page 1…ndment) 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 (K] 10354) Device The Synthes Anterolateral Distal Ti… | 2010 |
| * | K110354 | 4.5MM VA-LCP Curved Condylar Plate System | 2011 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 1.2 years on median.
- 25 of the 104 ancestors have a recall of any class.
- Of its descendants, K171320 (Meril Healthcare Pvt., Ltd., 2018) has gone furthest, with 2 descendants of its own.
- 8 other devices also cite its predicate K120854.
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 2.7/3.5mm 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, * 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. * Medial and…
Read the full statement (154 words)
The Synthes 2.7/3.5mm 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,
* 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.
* 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 osteotomnies, 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.
https://510kreport.com/device/K121601 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121601: Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121601
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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