510(k) · Cleared
ClearedGREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Greens Surgicals Pvt., Ltd. · HRS Plate, Fixation, Bone
Cleared on Apr 19, 2017 as substantially equivalent to K033995 (Synthes (Usa), 2004) and 26 other predicates after a 139-day review. Its family tree reaches back 11 generations to 1996. 3 later devices descend from it.
- Decided
- Apr 19, 2017
- Review
- 139 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 27
Its longest line of descent runs back 11 generations to K962616 (1996). 117 ancestors in all, the oldest K792022 (1979). 3 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 7 generations between
- 3 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 2 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 1 generation backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- This deviceK163383 GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating…Greens Surgicals Pvt., Ltd. · 2017
- Descendant · cites it directly · 2 of its ownK242939 ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024
- Descendant · 2 generations on · 0 of its ownK261830 FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate…Ortler Global Tibbi Gerecler Anonim Sirketi · 2026
- Descendant · 2 generations on · 0 of its ownK260277 Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti. · 2026
Show all 11 generations
- Root · 11 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 10 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 9 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 8 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 7 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 6 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 5 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 4 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 3 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 2 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 1 generation backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- This deviceK163383 GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating…Greens Surgicals Pvt., Ltd. · 2017
Most influential descendants
Showing 3 of 3 · See all- K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024 · cites it directly2descendants
- K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi · 2026 · 2 generations on0descendants
- K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −10 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −9 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −8 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −7 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −6 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −5 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −4 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −3 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −2 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −1 | K112583 | Synthes Cortical Screws | Synthes (USA) Products, LLC | 2011 | — |
| 0 (this device) | K163383 | GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System… | Greens Surgicals Pvt., Ltd. | 2017 | — |
| +1 | K242939 | ARTFX Trauma Bone Plate and Screw System | Artfx Medical | 2024 | — |
| +2 | K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System… | Ortler Global Tibbi Gerecler Anonim Sirketi | 2026 | — |
| +2 | K260277 | Mikron Trauma Bone Plate& Screw System | Mikron Makina San. ve Tic. Ltd. Sti. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1984 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 7 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 10 | 0 |
| 2001 | 12 | 0 |
| 2002 | 4 | 0 |
| 2003 | 8 | 0 |
| 2004 | 6 | 0 |
| 2005 | 6 | 0 |
| 2006 | 9 | 0 |
| 2007 | 4 | 0 |
| 2008 | 7 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 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? (27)
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 |
|---|---|---|---|
| * | K033995 | 3.5 MM LCP Distal Humerus SystemSummary page 6…Synthes 3.5mm LCP Elbow System 01. Locking Posterolateral Distal Humerus Plate (K033995) 2.7/3.5mm K012114 (Synthes locking distal rad… | 2004 |
| * | K012114 | Synthes Locking Distal Radius Plating SystemSummary page 6…(K033995) 2.7/3.5mm K012114 (Synthes locking distal radius 02. Locking Distal Dorsal Radius T-Plates 2.7mm plating system) 03.… | 2001 |
| * | K040777 | LCP Radial Head Plating SystemSummary page 6…) 03. Locking Volar Distal Radius Plate Extra-Articular LCP Radial Head Plating Plates Ø 2.4mm/2.7mm Left and Right System (K040777) Synthes Small Fragment Dynamic 04. 3.5MM Small Lo… | 2004 |
| * | K000684 | Small Fragment Dynamic Compression Locking (DCL) SystemSummary page 6…ic 04. 3.5MM Small Locking T- Plate 3.5mm Compression Locking( DCL) System(K000684) Small Fragment 05. 3.5mm Locking Plate K082807 Synthes (USA) 3.5 nun and… | 2000 |
| * | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSummary page 6…L) System(K000684) Small Fragment 05. 3.5mm Locking Plate K082807 Synthes (USA) 3.5 nun and 4.5 nun Locking Compression Plate 0… | 2008 |
| * | K001945 | Synthes (Usa) Medial Distal Tibia PlatesSummary page 6…Locking Medial Distal Tibia Plate 3.5mm / Synthes (USA) Medial Distal Tibia 4.0mm Left & Right Plate (K001945) CONFIDENTIAL SECTION 5 PAGE 3 OF 9… | 2000 |
| * | K030597 | Synthes 3.5MM Titanium LCP Proximal Tibia PlatesSummary page 7…Synthes 3.5mm Titanium LCP 09. 3.5MM Locking Proximal Tibia Plate, Left& Right Proximal Tibia Plate (K030597) OR Synthes LCP Proximal Tibia Plates… | 2003 |
| * | K011978 | Synthes LCP Proximal Tibia PlateSummary page 7…(K030597) OR Synthes LCP Proximal Tibia Plates (K011978) 10. 3.5mm Locking Reconstruction Plate Synthes 4.5 mm LCP Straight… | 2001 |
| * | K051986 | Synthes 4.5 MM LCP Straight Reconstruction PlatesSummary page 7…. 3.5mm Locking Reconstruction Plate Synthes 4.5 mm LCP Straight Reconstruction Plate (K051986) Synthes Clavicle Hook Plate 11. Locking Clavicle Hook Plate… | 2005 |
| * | K061753 | Synthes (Usa) Clavicle Hook PlatesSummary page 7…on Plate (K051986) Synthes Clavicle Hook Plate 11. Locking Clavicle Hook Plate Ø 3.5mm, Left & (K061753) Right 12. 3.5mm Locking Periarticular Proximal Humerus Synthes (USA) 3.5mm LCP Plate, Left a… | 2006 |
| * | K082625 | Synthes (Usa) 3.5MM LCP Periarticular Proximal Humerus PlatesSummary page 7….5mm LCP Plate, Left and Right Periarticular Proximal Humerus Plates (K082625) Proximal Humerus Plate Long 13. 3.5MM Locking Proximal Hume… | 2008 |
| * | K041860 | Synthes (Usa) LCP Proximal Humerus Plates, LongSummary page 7…(K082625) Proximal Humerus Plate Long 13. 3.5MM Locking Proximal Humerus Plate Synthes K041860 14. 3.5MM Locking Superior Anterior Clavicle Synthes 3.5mm LCP Clavicle Plate Plates, Left and Right… | 2004 |
| * | K111540 | Synthes 3.5MM LCP Clavicle Plate SystemSummary page 7…1860 14. 3.5MM Locking Superior Anterior Clavicle Synthes 3.5mm LCP Clavicle Plate Plates, Left and Right System (K111540) 15. 3.5MM Locking Anterolateral Distal Tibia Plate, Synthes (USA) 2.7mm / 3.5mm LCP Left and Right… | 2011 |
| * | K092812 | Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia PlatesSummary page 7…m / 3.5mm LCP Left and Right Anterolateral Distal Tibia Plate (k092812) 16. 3.5MM Locking Medial Proximal Tibia Plate Left Synthes (USA) 3.5 / 4.5mm LCP® and Right… | 2010 |
| * | K032269 | Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia PlatesSummary page 7….5MM Locking Medial Proximal Tibia Plate Left Synthes (USA) 3.5 / 4.5mm LCP® and Right Medial Proximal Tibia Plate (K032269) 17. 3.5mm Locking Posteromedial Proximal Tibia Synthes (USA) 3.5mm LCP Plate Right and Left… | 2003 |
| * | K082624 | Synthes (Usa) 3.5MM LCP Posteromedial Proximal Tibia Plates Our reading of the summary gave K082628, FDA’s number for CMR42 Cardiac Mri Imaging System, 2.1.23 (Circle Cardiovascular Imaging, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Synthes (USA) 3.5mm LCP Posteromedial Proximal Tibia Plates”. | 2008 |
| * | K073460 | Synthes 2.7 MM/3.5 MM LCP Distal Fibula PlatesSummary page 7…18. 3.5MM Locking Distal Fibula Plate, Left and Synthes 2.7mm / 3.5mm LCP Distal Right Fibula Plate (K073460) Large Fragment Synthes 3.5 and 4.5mm Locking 19. Narrow Lo… | 2008 |
| * | K062564 | Synthes LCP Distal Femur PlatesSummary page 8…(K082807) 22. Locking Distal Femur Plate, Right Synthes LCP Distal Femur Locking Distal Femur Plate, Left Plates (K062564) 23. Proximal Lateral Tibia Locking Plate, Left Synthes LCP Proximal Tibia Proximal Lateral Tibia… | 2006 |
| * | K030858 | Synthes (Usa) LCP Proximal Femur Plate and ScrewsSummary page 8…Locking Proximal Femur Plate 4.5/5.0/6.5mm Synthes (USA) LCP Proximal Femur Left & Right Plate and Screw (K030858) 25. Locking Philos Proximal Humeral Plate - Long Synthes (USA) LCP® Proximal… | 2003 |
| * | K011815 | Synthes LCP Proximal Humerus PlatesSummary page 8…K041860) Locking Philos Proximal Humeral Plate - Short Synthes LCP Proximal Humerus Plates K011815 Synthes 3.5 and 4.5mm Locking 26. Broad LC DCP Plate, 4.5… | 2001 |
| * | K923613 | Synthes Limited Contact-Dynamic Hip Screw ImplantSummary page 8…mic Hip Screw (Non-Locking) Plate (with Synthes Limited Contact-Dynamic Hip 28. Dynamic Compression Holes) (Long Barrel) Screw Implant (LC-DHS)” for K923613 Dynamic Hip Screw (Non-Locking) Plate (with Synthes Titanium Limited Contact- Dynamic Compressio… | 1993 |
| * | K953607 | Titanium Limited Contact Dynamic Hip Screw Plate (Tilc-DHS)Summary page 8…- Dynamic Compression Holes) (Short Barrel) Dynamic Hip Screw Implant (Ti LC- DHS)” for K953607 Synthes dynamic condylar screw or 29. Dynamic Condylar P… | 1996 |
| * | K840954 | Dynamic Condylar Screw or D.C.S.Summary page 8…607 Synthes dynamic condylar screw or 29. Dynamic Condylar Plate with Dynamic D.C.S. K840954 Compression Holes (Barrel length 25 mm) Synthes Limi… | 1984 |
| * | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSummary page 8…mm variable angle 32. Locking Head Screw, Ø 2.7mm - Self Tapping LCP Forefoot/Midfoot System K100776 33. Locking Head Screw, Ø 3.5mm - Self Tapping Synthes Small Fragment Dynamic CONFIDENTIAL… | 2010 |
| * | K112583 | Synthes Cortical ScrewsSummary page 9…(K000684) 34. Cortex Screw Ø 3.5mm, Self Tapping Synthes Cortical Screws K112583 35. Cortex Screw Ø 4.5mm, Self Tapping Synthes Cortical Screws K112583… | 2011 |
| * | K000682 | Synthes Large Fragment Dynamic Compression Locking (DCL) SystemSummary page 9…c 36. Locking Head Screw, Ø 5.0mm - Self Tapping Compression Locking (DCL) System (K000682) 37. Cancellous Screw, Ø6.5mm, 16mm Thread, Synthes (USA) 6.5 mm Cancellous 32mm Thread… | 2000 |
| * | K061621 | Synthes (Usa) 6.5 MM Cancellous ScrewsSummary page 9…Cancellous Screw, Ø6.5mm, 16mm Thread, Synthes (USA) 6.5 mm Cancellous 32mm Thread and Full Thread Screws (K061621) a4). A description of the device that is the subject of the premarket notification submission, such as might be found in the… | 2006 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242939 | ARTFX Trauma Bone Plate and Screw System | 2024 | 2 |
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 21 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 22 of the 117 ancestors have a recall of any class.
- Of its descendants, K242939 (Artfx Medical, 2024) has gone furthest, with 2 descendants of its own.
- 23 other devices also cite its predicate K033995.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS Brand of DHS/Dynamic Condylar Plate Plating System are provided non-sterile. GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System are indicated for treating fractures of various bones including the clavicle, pelvis, scapula, long bone ( humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges). GREENS Brand of…
Read the full statement (107 words)
GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS Brand of DHS/Dynamic Condylar Plate Plating System are provided non-sterile.
GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System are indicated for treating fractures of various bones including the clavicle, pelvis, scapula, long bone ( humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges).
GREENS Brand of DHS/Dynamic Condylar Plate Plating System is used to provide fixation of fractures to the proximal femur shaft and generally indicated for use in trochanteric, pertrochanteric, intertrochanteric fractures.
The system is indicated for use in adult patients only. All implants are for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163383 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163383: GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163383
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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