510(k) · Cleared
ClearedNebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nebula Surgical Private Limited · HRS Plate, Fixation, Bone
Cleared on Dec 9, 2019 as substantially equivalent to K953644 (Synthes (Usa), 1996) and 19 other predicates after a 159-day review. Its family tree reaches back 11 generations to 1996. 3 later devices descend from it.
- Decided
- Dec 9, 2019
- Review
- 159 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 20
Its longest line of descent runs back 11 generations to K962616 (1996). 111 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 deviceK191793 Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating…Nebula Surgical Private Limited · 2019
- 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 deviceK191793 Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating…Nebula Surgical Private Limited · 2019
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) | K191793 | Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System… | Nebula Surgical Private Limited | 2019 | — |
| +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 |
| 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 | 9 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 10 | 0 |
| 2001 | 10 | 0 |
| 2002 | 4 | 0 |
| 2003 | 7 | 0 |
| 2004 | 5 | 0 |
| 2005 | 6 | 0 |
| 2006 | 8 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 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? (20)
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 |
|---|---|---|---|
| * | K953644 | Volar Distal Radius PlateSummary page 4…Small Fragment Distal Radius Volar Locking Plate, 01 Synthes (USA) VOLAR DISTAL RADIUS PLATE(K953644) Left & Right 02 Small Locking Plate Synthes (USA) 3.5 mm and 4.5 mm Lockin… | 1996 |
| * | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSummary page 4…RADIUS PLATE(K953644) Left & Right 02 Small Locking Plate Synthes (USA) 3.5 mm and 4.5 mm Locking Compression Plate(K082807) Distal Tibial Medial Locking Plate, 03 Synthes (USA) Me… | 2008 |
| * | K001945 | Synthes (Usa) Medial Distal Tibia PlatesSummary page 4…n Plate(K082807) Distal Tibial Medial Locking Plate, 03 Synthes (USA) Medial Distal Tibia Plate (K001945) Left & Right Reconstruction Locking Plate 04… | 2000 |
| * | K051986 | Synthes 4.5 MM LCP Straight Reconstruction PlatesSummary page 4…Left & Right Reconstruction Locking Plate 04 Synthes 4.5 mm LCP Straight Reconstruction Plate (K051986) 3.5mm Clavicle Medial Locking Plate, Left 05… | 2005 |
| * | K111540 | Synthes 3.5MM LCP Clavicle Plate SystemSummary page 4…3.5mm Clavicle Medial Locking Plate, Left 05 Synthes 3.5mm LCP Clavicle Plate System (K111540) & Right Page 1 of 4… | 2011 |
| * | K033995 | 3.5 MM LCP Distal Humerus SystemSummary page 5…510(k) Summary Distal Humerus D/L @ Support 06 Synthes 3.5 MM LCPDISTAL HUMERUS SYSTEM (K033995) LCP, Left & Right Distal Humerus Medial LCP Plate, 07 Synth… | 2004 |
| * | K073460 | Synthes 2.7 MM/3.5 MM LCP Distal Fibula PlatesSummary page 5…5 MM LCP DISTAL HUMERUS SYSTEM (K033995) Left & Right 08 Distal Fibula VA LCP, Left and Right Synthes 2.7mm / 3.5mm LCP Distal Fibula Plate (K073460) Anterolateral Distal Tibia Locking Synthes (USA) 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plate 09… | 2008 |
| * | K092812 | Synthes (Usa) 2.7MM/ 3.5MM LCP Anterolateral Distal Tibia PlatesSummary page 5…Distal Tibia Locking Synthes (USA) 2.7mm / 3.5mm LCP Anterolateral Distal Tibia Plate 09 Plate, Left & Right (K092812) Medial Proximal Tibia Locking 10 Synthes (USA) 3.5 / 4.5mm LCP® Medial Proximal… | 2010 |
| * | K032269 | Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia PlatesSummary page 5…(K092812) Medial Proximal Tibia Locking 10 Synthes (USA) 3.5 / 4.5mm LCP® Medial Proximal Tibia Plate (K032269) Plate, Left & Right Posterior Medial Proximal Tibial 11… | 2003 |
| * | K030597 | Synthes 3.5MM Titanium LCP Proximal Tibia PlatesSummary page 5…Plate, Left & Right Posterior Medial Proximal Tibial 11 Synthes 3.5mm LCP Proximal Tibia Plates(K030597) Locking Plate Anatomical Proximal Tibia Locking 12 SYNTHES… | 2003 |
| * | K961413 | Synthes Anatomical Locking Plate SystemSummary page 5…030597) Locking Plate Anatomical Proximal Tibia Locking 12 SYNTHES ANATOMICAL LOCKING PLATE SYSTEM (K961413) Plate, Left and Right Large Fragment Narrow and Broad Locking… | 1996 |
| * | K062564 | Synthes LCP Distal Femur PlatesSummary page 5…ing Compression Plate System (K082807) Distal Femur Locking Plate, Right & 15 Synthes LCP Distal FemurPlates (K062564) Left Lateral Tibia Locking Plate, Right & 16… | 2006 |
| * | K011978 | Synthes LCP Proximal Tibia PlateSummary page 5…62564) Left Lateral Tibia Locking Plate, Right & 16 Synthes LCP Proximal Tibia Plate (K011978) Left 17 Philos Locking Plate Synthes (USA) LCP® Proximal Humerus Plates, Long (K… | 2001 |
| * | K041860 | Synthes (Usa) LCP Proximal Humerus Plates, LongSummary page 5…Synthes LCP Proximal Tibia Plate (K011978) Left 17 Philos Locking Plate Synthes (USA) LCP® Proximal Humerus Plates, Long (K041860) 18 Narrow LC DCP Plate, 3.5mm Synthes 3.5 and 4.5mm Locking Compression Plate System (K082807) D.H.S. Pla… | 2004 |
| * | K923613 | Synthes Limited Contact-Dynamic Hip Screw ImplantSummary page 5…Limited Contact- Dynamic Hip Screw Implant (LC-DHS) for Dynamic Hip Screw (Non- Locking) K923613S Long Barrel and Short Barrel D.H.S. 19 Plate 130 Degree with Dynamic Hip… | 1993 |
| * | K953607 | Titanium Limited Contact Dynamic Hip Screw Plate (Tilc-DHS)Summary page 5…nium Limited Contact-Dynamic Hip Screw Implant Screw (Non- Locking) Long Barrel (Ti LC- DHS) for K953607 and Short Barrel Locking and Non-Locking Screw… | 1996 |
| * | K000684 | Small Fragment Dynamic Compression Locking (DCL) SystemSummary page 5…crew, Ø 2.7mm - Self Synthes Small Fragment Dynamic CompressionLocking (DCL) System 21 Tapping (K000684) Locking Screw, Ø 3.5mm - Self Synthes Small Fragment Dynamic Compression Locking (DCL) System 22… | 2000 |
| * | K112583 | Synthes Cortical ScrewsSummary page 5…(K000684) Cortical Screw Ø 3.5mm 20 TPI 23 Synthes Cortical Screws K112583 (Self Tapping) Cannulated Cancellous Screw Ø 4.0 24 mm, 16mm Thread, 32mm Thread Syn… | 2011 |
| * | K061621 | Synthes (Usa) 6.5 MM Cancellous ScrewsSummary page 5…583 (Self Tapping) Cannulated Cancellous Screw Ø 4.0 24 mm, 16mm Thread, 32mm Thread Synthes (USA) 6.5 mm Cancellous Screws (K061621) and Full Thread Cortical Screw Ø 4.5mm, 25… | 2006 |
| * | K000682 | Synthes Large Fragment Dynamic Compression Locking (DCL) SystemSummary page 5…g Screw, Ø4.9 mm Synthes Large Fragment Dynamic Compression Locking (DCL) System 26 Self-Tapping (K000682) Cancellous Screw, Ø6.5mm, 16mm Thread, 32mm Thread and Full Synthes (USA) 6.5 mm Cancellous Screws… | 2000 |
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 23 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 20 of the 111 ancestors have a recall of any class.
- Of its descendants, K242939 (Artfx Medical, 2024) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K953644.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2007high 76 (2014) · low 35 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
2007high 144 (2022) · low 57 (2014)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
2007high 25 (2019) · low 0 (2014)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
2007high 3,359 (2019) · low 311 (2008)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?
NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System are provided non-sterile.
NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS 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).
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/K191793 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191793: Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS 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/K191793
Report an extraction error
Are you the manufacturer?
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