510(k) · Cleared
ClearedTibia and Fibula System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Auxein Medical Private Limited · HRS Plate, Fixation, Bone
Cleared on Jan 27, 2023 as substantially equivalent to K013248 (Synthes (Usa), 2001) after a 492-day review. Its family tree reaches back 1 generation to 2001. 2 later devices descend from it.
- Decided
- Jan 27, 2023
- Review
- 492 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K013248 (2001). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK013248 Synthes LCP Distal Tibia PlatesSynthes (Usa) · 2001
- This deviceK213059 Tibia and Fibula SystemAuxein Medical Private Limited · 2023
- Descendant · cites it directly · 0 of its ownK240181 Clavicle and Scapula SystemAuxein Medical Pvt., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK232115 TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013248 | Synthes LCP Distal Tibia Plates | Synthes (Usa) | 2001 | — |
| 0 (this device) | K213059 | Tibia and Fibula System | Auxein Medical Private Limited | 2023 | — |
| +1 | K240181 | Clavicle and Scapula System | Auxein Medical Pvt., Ltd. | 2024 | — |
| +1 | K232115 | TDM Large Bone Plate and Screw System | Tdm Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K013248 | Synthes LCP Distal Tibia PlatesSummary page 9…e: The following is the range of variants covered with their corresponding predicate devices. Primary Predicate device: 510K Number K013248 Applicant Synthes, USA Device Name 3.5mm LCP Medial D… | 2001 |
| † | K073460 | Synthes 2.7 MM/3.5 MM LCP Distal Fibula Plates | 2008 |
| † | K141680 | AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN… | 2015 |
| † | K020602 | Synthes Pilon Plate | 2002 |
| † | K111039 | Zimmer Periarticular Locking Plate System | 2011 |
| † | K061098 | Ebi Optilock Periarticular Plating System | 2006 |
| † | K052390 | Synthes LCP Proximal Tibia Plates Line Extension | 2005 |
| † | K050646 | Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia Plates | 2005 |
| † | K030597 | Synthes 3.5MM Titanium LCP Proximal Tibia Plates | 2003 |
| † | K011978 | Synthes LCP Proximal Tibia Plate | 2001 |
| † | K120854 | Synthes VA LCP Ankle Trauma System | 2012 |
| † | K120689 | Synthes 3.5 MM VA-LCP Proximal Tibia Plate System | 2012 |
| † | K082624 | Synthes (Usa) 3.5MM LCP Posteromedial Proximal Tibia Plates | 2008 |
| † | K120360 | Ortho Solutions Trauma Plates for Osteosysnthesis | 2012 |
What descends from it? (2)
2 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?
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Wise-Lock Tibia & Fibula System The Wise-Lock Tibia & Fibula System plates are intended for fracture fixation. Indications for the plates included in the system as follows: 3.5mm Wise-Lock Medial Distal Tibia Plate: Medial distal tibia plates are indicated for treating fractures of the tibia. 3.5mm Wise-Lock Proximal Tibia Plate: 3.5mm Wise-Lock Proximal Tibia Plate indicated for treating fractures of the tibia. 3.5mm Wise-Lock Medial Proximal Tibia…
Read the full statement (934 words)
Wise-Lock Tibia & Fibula System
The Wise-Lock Tibia & Fibula System plates are intended for fracture fixation. Indications for the plates included in the system as follows:
3.5mm Wise-Lock Medial Distal Tibia Plate:
Medial distal tibia plates are indicated for treating fractures of the tibia.
3.5mm Wise-Lock Proximal Tibia Plate:
3.5mm Wise-Lock Proximal Tibia Plate indicated for treating fractures of the tibia.
3.5mm Wise-Lock Medial Proximal Tibia Plate:
The 3.5mm Wise-Lock Medial Proximal Tibia Plates are 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. The plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia.
3.5mm Wise-Lock Posterior Medial Proximal Tibia Plate:
3.5mm Wise-Lock Posterior Medial Proximal Tibia Plates are indicated for internal fixation of posteromedial proximal tibia fractures including buttressing of fractures of the proximal, distal, and metaphyseal areas of the tibia.
3.5mm Wise-Lock Anterolateral Distal Tibia Plate:
3.5mm Wise-Lock Anterolateral Distal Tibia Plate indicated for treating fractures of the tibia.
3.5mm Wise-Lock Medial Distal Tibia Plate, Without Tab:
The 3.5mm Wise-Lock Medial Distal Tibia Plate, Without Tab is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia.
3.5mm Wise-Lock Low Profile Medial Distal Tibia Plate, Without Tab:
The 3.5mm Wise-Lock Low Profile Medial Distal Tibia Plate, Without Tab is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia.
3.5mm Wise-Lock Lateral Distal Fibula Plate:
The 3.5mm Wise-Lock Lateral Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula.
3.5mm Wise-Lock Metaphyseal Plate For Medial Distal Tibia:
The 3.5mm Wise-Lock Metaphyseal Plate For Medial Distal Tibia is indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula.
3.5mm Wise-Lock Pilon Plate:
The 3.5mm Wise-Lock Pilon Plate is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia.
3.5mm Wise-Lock Pilon Plate, Cruciform:
3.5mm Wise-Lock Pilon Plate, Cruciform is indicated for fixation of complex intra-and extra-articular fractures and osteotomies of the distal tibia.
3.5mm Wise-Lock Z-type Distal Medial Tibial Plate:
The 3.5mm Wise-Lock Z-type Distal Medial Tibial Plate is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including:
Comminuted fractures
Supracondylar fractures
Intra-articular and extra-articular condylar fractures
Non-unions, and
Malunions
3.5mm Wise-Lock Z-type Proximal Lateral Tibial Plate:
The 3.5mm Wise-Lock Z-type Proximal Lateral Tibial Plate is intended for fixation of fractures and osteotomies involving the tibia. The plate is indicated for the the follow:
Treatment of non-unions, malunions and fractures of the proximal tibia, including simple, comminuted lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression and fractures with associated shaft fractures.
To buttress Metaphyseal fractures of the medial tibial plateau, split-type fractures of the medial tibial plateau, medial split fractures with associated depressions and split of depression fractures of the medial tibia plateau.
The fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intra articular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.
4.5/5.0mm Wise-Lock Proximal Lateral Tibia Plate:
The 4.5/5.0mm Wise-Lock Proximal Lateral Tibia Plate is indicated for treatment of nonunions, malunions, tibial osteotomies (4.5mm plate only), and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.
4.5/5.0mm Wise-Lock Medial Proximal Tibia Plate:
The 4.5/5.0mm Wise-Lock Medial Proximal Tibia Plates are 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. The plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia. The 4.5mm version may also be used for fixation of nonunions and malunions of the medial proximal tibia and tibia shaft, as well as opening and closing wedge tibial osteotomies.
4.5/5.0mm Wise-Lock Proximal Tibia Plate:
4.5/5.0mm Wise-Lock Proximal Tibia Plate is indicated for treatment of non-unions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.
AV-Wise Lock Ankle System
The AV-Wise Lock Ankle System is intended for fixation of the ankle in adults and adolescents (12-21) in which the growth plates have fused. Indications for plates included in the system are as follows:
Medial and Anteromedial Distal Tibia Plates are indicated 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 indicated to buttress partial articular fractures and bone fragments of the distal tibia, and
Lateral Distal Fibula Plates are indicated for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.
AV-Wise Lock Proximal Tibia Plates
The AV-Wise Lock Proximal Tibia Plates are indicated 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213059 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213059: Tibia and Fibula System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213059
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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