510(k) · Cleared
ClearedNET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Narang Medical Limited · HRS Plate, Fixation, Bone
Cleared on Nov 25, 2015 as substantially equivalent to K011815 (Synthes (Usa), 2001) and 14 other predicates after a 264-day review. Its family tree reaches back 11 generations to 1996. 1 later device descends from it.
- Decided
- Nov 25, 2015
- Review
- 264 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 15
Its longest line of descent runs back 11 generations to K962616 (1996). 97 ancestors in all, the oldest K792022 (1979). 1 later device descends 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 deviceK150561 NET Brand Small Fragment and Large Fragment Osteosynthesis Plating…Narang Medical Limited · 2015
- Descendant · cites it directly · 0 of its ownK163425 NMUC Brand Small And Large Fragment Osteosynthesis Plating System…Narang Medical USA Corporation · 2017
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 deviceK150561 NET Brand Small Fragment and Large Fragment Osteosynthesis Plating…Narang Medical Limited · 2015
Most influential descendants
Showing 1 of 1 · See all- K163425NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS…Narang Medical USA Corporation · 2017 · cites it directly0descendants
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) | K150561 | NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET… | Narang Medical Limited | 2015 | — |
| +1 | K163425 | NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand… | Narang Medical USA Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 7 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 9 | 0 |
| 2001 | 10 | 0 |
| 2002 | 3 | 0 |
| 2003 | 7 | 0 |
| 2004 | 5 | 0 |
| 2005 | 6 | 0 |
| 2006 | 8 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (15)
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 |
|---|---|---|---|
| * | K011815 | Synthes LCP Proximal Humerus PlatesSummary page 7…Filos ‐ Proximal Humerus 1. Synthes LCP Proximal K011815 Synthes (USA) Safety Lock Plate 3.5 – Humerus Plate Standard… | 2001 |
| * | K033995 | 3.5 MM LCP Distal Humerus SystemSummary page 7…Standard 3.5 mm LCP Distal Humerus Distal Humerus Safety Lock 2. K033995 Synthes (USA) System Plate 2.7/3.5, Dorsolateral… | 2004 |
| * | K000684 | Small Fragment Dynamic Compression Locking (DCL) SystemSummary page 7…System Lock Plate 2.7/3.5mm Synthes Small Fragment Dynamic 5. Compression Locking (DCL) K000684 Synthes (USA) LC‐DCP Safety Lock Plate 3.5 System Synthes Small Fragment… | 2000 |
| * | K061753 | Synthes (Usa) Clavicle Hook PlatesSummary page 7…Clavicle Hook Safety Lock Plate 3.5 8. Synthes Clavicle Hook Plate K061753 Synthes (USA) Reconstruction Safety Lock Sy… | 2006 |
| * | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSummary page 8…Broad LC‐DCP Safety Lock mm Locking Compression Plate Plate 4.5 /5.0 12. K082807 Synthes (USA) (LCP) System with Expanded Indications Synthes (USA) 3.5 mm and 4.5 mm Locking Com… | 2008 |
| * | K030858 | Synthes (Usa) LCP Proximal Femur Plate and ScrewsSummary page 8…Proximal Femoral Safety Lock 14. Synthes (USA) LCP Proximal Plate 4.5/5.0/7.3 K030858 Synthes (USA) Femur Plate and Screws Dist… | 2003 |
| * | K062564 | Synthes LCP Distal Femur PlatesSummary page 8…Distal Femoral Safety Lock Plate 4.5/5.0 15. Synthes LCP Distal Femur Plates K062564 Synthes (USA) For Stainless Synthes LCP Proximal Tibia Plate Steel Pla… | 2006 |
| * | K011978 | Synthes LCP Proximal Tibia PlateSummary page 8…Synthes (USA) For Stainless Synthes LCP Proximal Tibia Plate Steel Plate (K011978) Proximal Lateral Tibial Safety 16. Lo… | 2001 |
| * | K023802 | Synthes 4.5 MM Titanium LCP Proximal Tibia Plating SystemSummary page 8…For Synthes (USA) Synthes 4.5 mm Titanium LCP Titanium Proximal Tibia Plating System Plate K023802 Synthes Small Fragment 17. Dynamic Compression K000684 Synthes (USA) Safety Lock 'T' Plate 4.5/… | 2003 |
| * | K051986 | Synthes 4.5 MM LCP Straight Reconstruction PlatesSummary page 8…em Synthes 4.5 mm LCP Reconstruction Safety Lock 20. Straight Reconstruction K051986 Synthes (USA) Plate 4.5/5.0 Plates S… | 2005 |
| * | K000682 | Synthes Large Fragment Dynamic Compression Locking (DCL) SystemSummary page 8…Plate 4.5/5.0 Plates Synthes Large Fragment Dynamic 21. Compression Locking (DCL) K000682 Synthes (USA) Safety Lock Screw Ø 5.0mm System SECTION 05… | 2000 |
| * | K923613 | Synthes Limited Contact-Dynamic Hip Screw ImplantSummary page 9…PAGE 5 OF 10 K150561 Page 6 of 10 Synthes Limited Contact- Dynamic Hip Screw Implant (LC- K 923613 DHS)” for K923613 Dynamic Hip Compression 22.… | 1993 |
| * | K953607 | Titanium Limited Contact Dynamic Hip Screw Plate (Tilc-DHS)Summary page 9…es (USA) Plate (with Dynamic Synthes Titanium Limited Compression Holes) Contact-Dynamic Hip Screw K953607 Implant (Ti LC-DHS)” for K953607 Synthes Limited Contact- Dynamic Hip Screw Implant (LC-… | 1996 |
| * | K840954 | Dynamic Condylar Screw or D.C.S.Summary page 9…DHS)” for K953607 DYNAMIC CONDYLAR DCS Plate 95° with Dynamic 24. K840954 Synthes (USA) SCREW OR D.C.S Compression Holes Synthes… | 1984 |
| * | K112583 | Synthes Cortical ScrewsSummary page 9…K953607 K953607 Cortex Screw Ø 3.5mm, Self 26. Synthes Cortical Screws K112583 Synthes (USA) Tapping… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163425 | NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS… | 2017 | 0 |
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 19 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 19 of the 97 ancestors have a recall of any class.
- Of its descendants, K163425 (Narang Medical USA Corporation, 2017) has gone furthest, with 0 descendants of its own.
- 24 other devices also cite its predicate K011815.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
NET Brand Small Fragment and Large Fragment Osteosynthesis System is intended for small and large bone fracture fixation, arthrodesis and osteotomy fixation. Examples include: fractures of the clavicle, scapula, humerus, olecranon, radius, ulna, distal femur, proximal tibia, tibial pilon, fibula, pelvis and acetabulum fractures; periprosthetic fractures; The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone. This…
Read the full statement (113 words)
NET Brand Small Fragment and Large Fragment Osteosynthesis System is intended for small and large bone fracture fixation, arthrodesis and osteotomy fixation. Examples include: fractures of the clavicle, scapula, humerus, olecranon, radius, ulna, distal femur, proximal tibia, tibial pilon, fibula, pelvis and acetabulum fractures; periprosthetic fractures; The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone. This system is not indicated for use in the spine.
NET Brand DHS/DCS plating system may be used for fixation of the fractures of proximal femur such as femoral neck, trochanteric, pertrochanteric or intertrochanteric zones.
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/K150561 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150561: NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150561
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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