510(k) · Cleared
ClearedARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meril Healthcare Pvt., Ltd. · HRS Plate, Fixation, Bone
Cleared on Mar 8, 2018 as substantially equivalent to K143331 (Zimmer, Inc., 2015) and 18 other predicates after a 308-day review. Its family tree reaches back 14 generations to 1996. 2 later devices descend from it.
- Decided
- Mar 8, 2018
- Review
- 308 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 19
Its longest line of descent runs back 14 generations to K962616 (1996). 141 ancestors in all, the oldest K792022 (1979). 2 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 10 generations between
- 3 generations backK120717 Synthes Variable Angle LCP Elbow System (Medical and Posterolateral…Synthes USA · 2012
- 2 generations backK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
- 1 generation backK121601 Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma…Synthes USA · 2012
- This deviceK171320 ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION…Meril Healthcare Pvt., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK241599 Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK200701 Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc. · 2020
Show all 14 generations
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 13 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 12 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 11 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 10 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 9 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 8 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 7 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 6 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 5 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 4 generations backK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
- 3 generations backK120717 Synthes Variable Angle LCP Elbow System (Medical and Posterolateral…Synthes USA · 2012
- 2 generations backK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
- 1 generation backK121601 Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma…Synthes USA · 2012
- This deviceK171320 ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION…Meril Healthcare Pvt., Ltd. · 2018
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 |
|---|---|---|---|---|---|
| −14 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −13 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −12 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −11 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −10 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −9 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −8 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −7 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −6 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −5 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −4 | K120070 | Synthes Variable Angle LCP Elbow System | Synthes USA | 2012 | 1 |
| −3 | K120717 | Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal… | Synthes USA | 2012 | — |
| −2 | K120854 | Synthes VA LCP Ankle Trauma System | Synthes USA | 2012 | — |
| −1 | K121601 | Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal… | Synthes USA | 2012 | — |
| 0 (this device) | K171320 | ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws… | Meril Healthcare Pvt., Ltd. | 2018 | — |
| +1 | K241599 | Signature Osteosynthesis Plate System | Signature Orthopaedic Pty, Ltd. | 2025 | — |
| +1 | K200701 | Skeletal Dynamics Midshaft Humerus Plating System | Skeletal Dynamics, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 9 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 10 | 0 |
| 2001 | 12 | 0 |
| 2002 | 5 | 0 |
| 2003 | 6 | 0 |
| 2004 | 12 | 0 |
| 2005 | 8 | 0 |
| 2006 | 11 | 0 |
| 2007 | 4 | 0 |
| 2008 | 7 | 0 |
| 2009 | 6 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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? (19)
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 |
|---|---|---|---|
| * | K143331 | Zimmer Plates and Screws System (ZPS) - Non-sterile ZPSSummary page 12…e 510k Number Manufacturer Name Type K143331, K083654 Bone Plates Zimmer Primary K121672, K120717, Pl… | 2015 |
| * | K083654 | Zimmer Universal Locking System 2.7 MM Locking Plates and Screws ( Tivanium TI-6A1-4V…Summary page 12…510k Number Manufacturer Name Type K143331, K083654 Bone Plates Zimmer Primary K121672, K120717, Plate Syste… | 2009 |
| * | K121672 | Aft Proximal Humerus Fracture PlateSummary page 12…Name Type K143331, K083654 Bone Plates Zimmer Primary K121672, K120717, Plate System Synthes Additional K082625 K1216… | 2012 |
| * | K120717 | Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Summary page 12…Name Type K143331, K083654 Bone Plates Zimmer Primary K121672, K120717, Plate System Synthes Additional K082625 K121601, K1208… | 2012 |
| * | K082625 | Synthes (Usa) 3.5MM LCP Periarticular Proximal Humerus PlatesSummary page 12…Zimmer Primary K121672, K120717, Plate System Synthes Additional K082625 K121601, K120854 Ankle Trauma System Synthes Additional K110125, K102694,… | 2008 |
| * | K121601 | Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSummary page 12…Zimmer Primary K121672, K120717, Plate System Synthes Additional K082625 K121601, K120854 Ankle Trauma System Synthes Additional K110125, K102694,… | 2012 |
| * | K120854 | Synthes VA LCP Ankle Trauma SystemSummary page 12…r Primary K121672, K120717, Plate System Synthes Additional K082625 K121601, K120854 Ankle Trauma System Synthes Additional K110125, K102694, Distal R… | 2012 |
| * | K110125 | 2.4 MM VA-LCP Volar Rim Distal Radius SystemSummary page 12…stem Synthes Additional K082625 K121601, K120854 Ankle Trauma System Synthes Additional K110125, K102694, Distal Radius System Synthes Additional K953644 K0617… | 2011 |
| * | K102694 | 2.4MM VA-LCP Dorsal Distal Radius PlatesSummary page 12…Synthes Additional K082625 K121601, K120854 Ankle Trauma System Synthes Additional K110125, K102694, Distal Radius System Synthes Additional K953644 K061753… | 2010 |
| * | K953644 | Volar Distal Radius PlateSummary page 12…m Synthes Additional K110125, K102694, Distal Radius System Synthes Additional K953644 K061753 Clavicle Hook Plate Synthes Additional… | 1996 |
| * | K061753 | Synthes (Usa) Clavicle Hook PlatesSummary page 12…Synthes Additional K110125, K102694, Distal Radius System Synthes Additional K953644 K061753 Clavicle Hook Plate Synthes Additional… | 2006 |
| * | K070946 | Synthes LCP Diaphyseal-Metaphyseal (Dia-Meta) Volar Distal Radius PlatesSummary page 13…Page 3 of 4 510(K) SUMMARY 510(K) K171320 K070946, K031573 Pelvic Plates Synthes Additional K020401 Calcaneal Plate Synth… | 2007 |
| * | K031573 | Synthes 3.5 MM Low Profile Pelvic Reconstruction PlateSummary page 13…Page 3 of 4 510(K) SUMMARY 510(K) K171320 K070946, K031573 Pelvic Plates Synthes Additional K020401 Calcaneal Plate Synthes Add… | 2003 |
| * | K020401 | Synthes Calcaneal PlateSummary page 13…510(K) SUMMARY 510(K) K171320 K070946, K031573 Pelvic Plates Synthes Additional K020401 Calcaneal Plate Synthes Additional Cortical Screws and DCL K… | 2002 |
| * | K112583 | Synthes Cortical ScrewsSummary page 13…Synthes Additional K020401 Calcaneal Plate Synthes Additional Cortical Screws and DCL K112583, K000682 Synthes Additional System K071264, K102694,… | 2011 |
| * | K000682 | Synthes Large Fragment Dynamic Compression Locking (DCL) SystemSummary page 13…thes Additional K020401 Calcaneal Plate Synthes Additional Cortical Screws and DCL K112583, K000682 Synthes Additional System K071264, K102694,… | 2000 |
| * | K071264 | Synthes (Usa) 2.4/2.7 MM Locking Foot ModuleSummary page 13…Cortical Screws and DCL K112583, K000682 Synthes Additional System K071264, K102694, Foot and Ankle Plates Synthes Additional K092609, K000682 K092609, K… | 2007 |
| * | K092609 | Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP)Summary page 13…Synthes Additional System K071264, K102694, Foot and Ankle Plates Synthes Additional K092609, K000682 K092609, K021932 Cancellous Screws Synthes Additional IV. PERFORMANCE DATA ARMAR™ /… | 2009 |
| * | K021932 | Synthes 6.5 MM Cannulated ScrewSummary page 13…System K071264, K102694, Foot and Ankle Plates Synthes Additional K092609, K000682 K092609, K021932 Cancellous Screws Synthes Additional IV. PERFORMANCE DATA ARMAR™ / ARTIS™ plates and MBOSS™/FIXION… | 2002 |
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?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 37 of the 141 ancestors have a recall of any class.
- Of its descendants, K241599 (Signature Orthopaedic Pty, Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K143331.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
ARMAR™ / ARTIS™ Small Fragment and Calcaneal Plates & MBOSS™/FIXION™ Screws are indicated for temporary internal fixation and stabilization of osteotomies and fractures, such as: • comminuted fractures • supracondylar fractures • extra-articular fractures • fractures in osteopenic bone • nonunions • malunions Smaller-sized ARMAR™ / ARTIS™ plates are used for small bones and small fragments of the hands and feet. ARMAR™ / ARTIS™ Calcaneal plates are…
Read the full statement (434 words)
ARMAR™ / ARTIS™ Small Fragment and Calcaneal Plates & MBOSS™/FIXION™ Screws are indicated for temporary internal fixation and stabilization of osteotomies and fractures, such as:
• comminuted fractures
• supracondylar fractures
• extra-articular fractures
• fractures in osteopenic bone
• nonunions
• malunions
Smaller-sized ARMAR™ / ARTIS™ plates are used for small bones and small fragments of the hands and feet.
ARMAR™ / ARTIS™ Calcaneal plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures of the calcaneous.
ARMAR™ / ARTIS™ Humerus and Olecranon plates & MBOSS™/FIXION™ Screws are intended for fractures and fracture dislocations, osteotomnies, and non-unions of the distal and proximal humerus, olecranon, and ulna in adult, particularly in osteopenic bone.
Specifically, distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distalhumerus. Olecranon and Proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna.
ARMAR™ / ARTIS™ Tibia and Buttress Plates & MBOSS™/FIXION™ Screws are intended for fixation of the ankle in adults. 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 Distal and Proximal 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,
• L Buttress and T Buttress Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and
• Proximal Lateral 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, a Distal Tibia T Plates and Distal Tibia L Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia.
ARMAR™ / ARTIS™ 2.4mm Plates & MBOSS™/FIXION™ Screws are intended for Fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults.
ARMAR™ / ARTIS™ Clavical Hook Plate & MBOSS™/FIXION™ Screws is intended for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.
ARMAR™ / ARTIS™ Metaphyseal Plate & MBOSS™/FIXION™ Screws indicated for fractures, osteotomies, and non-unions of the radius and other small bones. Additionally, the Metaphyseal Plate is intended for pelvic and acetabular reconstructive surgery and fracture fixation of the distal humerus, clavicle, and scapula.
ARMAR™ / ARTIS™ Calcaneal Plate & MBOSS™/FIXION™ Screws is intended for fixation of complex extra-articular and intra-articular fractures and osteotomies of the calcaneus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171320 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171320: ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171320
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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