510(k) · Cleared
ClearedNET BRAND Osteosynthesis Nailing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Narang Medical, Ltd. · JDS Nail, Fixation, Bone
Cleared on Feb 20, 2024 as substantially equivalent to K914453 (Synthes (Usa), 1992) and 7 other predicates after a 146-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Feb 20, 2024
- Review
- 146 days
- Class
- Class II
- Product code
- JDS
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 3 generations to K960642 (1996). 9 ancestors in all, the oldest K914453 (1992). No later device cites it as a predicate yet.
- Root · 3 generations backK960642 Nancy NailLandos, Inc. · 1996
- 2 generations backK971783 Synthes Elastic Intramedullary Nail (Ein) SystemSynthes (Usa) · 1997
- 1 generation backK032687 Ace Nancy NailDePuy Orthopaedics, Inc. · 2003
- This deviceK233150 NET BRAND Osteosynthesis Nailing SystemNarang Medical, Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960642 | Nancy Nail | Landos, Inc. | 1996 | — |
| −2 | K971783 | Synthes Elastic Intramedullary Nail (Ein) System | Synthes (Usa) | 1997 | — |
| −1 | K032687 | Ace Nancy Nail | DePuy Orthopaedics, Inc. | 2003 | — |
| 0 (this device) | K233150 | NET BRAND Osteosynthesis Nailing System | Narang Medical, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1996 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 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 JDS? 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 JDS device
- #1 K230761 TRIGEN META-NAIL Nail Systemscore 12.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
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 |
|---|---|---|---|
| * | K914453 | Universal Tibial Nail and Unreamed Tibial NailSummary page 7…YNTHES Titanium Tibia Nail Cannulated Locking Screw (Dual (K914453) Core) for Perfect Tibial Nails… | 1992 |
| * | K962047 | Titanium Cannulated Tibial Nail (TI CTN)Summary page 7…Multi-Fix Tibial Nail - Locking Bolt, Ø4.5mm SYNTHES Titanium Tibia Nail Cannulated (Dynamic Hole) (Self Tapping) for Multi- (K962047) Fix Nail Locking Bolt, Ø 6mm… | 1996 |
| * | K040336 | Synthes (Usa) Lateral Entry Femoral Nail SystemSummary page 7…ect Femoral Nail - Locking Bolt 6.0mm (Self SYNTHES Lateral Entry Cannulated (Long) for Right Tapping) Femoral Nail (K040336) and Left Leg Locking Bolt 4.9mm (Self Tapping)… | 2004 |
| * | K954856 | Cannulated Femoral NailSummary page 7…erfect Femoral Nail - Locking Bolt 6.0mm (Self SYNTHES Cannulated Femoral Cannulated (Short) Tapping) Nail (K954856) Locking Bolt 4.9mm (Self Tapping)… | 1996 |
| * | K011857 | Synthes (Usa) Trochanteric Fixation Nail (TFN) SystemSummary page 7…Nail, Antirotation – Short Bolt, Ø 4.9 mm (Self FIXATION NAIL (TFN) SYSTEM Tapping) (K011857 & K070294) PFNA-II Nail Blade Screw… | 2001 |
| * | K070294 | Synthes Trochanteric Fixation Nail (TFN) System, Additional Helical BladesSummary page 7…Antirotation – Short Bolt, Ø 4.9 mm (Self FIXATION NAIL (TFN) SYSTEM Tapping) (K011857 & K070294) PFNA-II Nail Blade Screw (Cannula… | 2007 |
| * | K971783 | Synthes Elastic Intramedullary Nail (Ein) SystemSummary page 8…Not Applicable Synthes Elastic Intramedullary nailing System (K971783) and Depuy Ace Nancy Nail… | 1997 |
| * | K032687 | Ace Nancy NailSummary page 8…Depuy Ace Nancy Nail (K032687) 10. Ø4.8mm Cancellous Locking Not Applicable SYNTHES Titanium Tibia Nail Screw (… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
- 3 of the 9 ancestors have a recall of any class.
- 12 other devices also cite its predicate K914453.
How does its category compare?
All JDS devicesJDS Nail, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · JDS
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDS
146in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDS
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDS
497in 2025
MAUDE reports naming product code JDS, 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 | 2 | — | 0 | 161 |
| 2008 | 1 | — | 0 | 169 |
| 2009 | 0 | — | 3 | 160 |
| 2010 | 0 | — | 2 | 70 |
| 2011 | 1 | — | 0 | 104 |
| 2012 | 0 | — | 0 | 195 |
| 2013 | 1 | — | 4 | 284 |
| 2014 | 0 | — | 0 | 388 |
| 2015 | 1 | — | 0 | 316 |
| 2016 | 0 | — | 0 | 506 |
| 2017 | 0 | — | 1 | 287 |
| 2018 | 0 | — | 0 | 320 |
| 2019 | 0 | — | 0 | 490 |
| 2020 | 3 | 106 | 1 | 643 |
| 2021 | 0 | — | 0 | 630 |
| 2022 | 0 | — | 0 | 589 |
| 2023 | 1 | — | 0 | 357 |
| 2024 | 3 | 146 | 0 | 466 |
| 2025 | 1 | — | 2 | 497 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
NET BRAND Osteosynthesis Nailing System are provided non-sterile. Tibial Nails are indicated for stabilization of fractures of proximal and distal tibia, tibial shaft, open and closed tibial shaft fractures, certain pre and postisthmic fractures, non-unions and malunions. Femoral Nails are indicated for stabilization of femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and…
Read the full statement (137 words)
NET BRAND Osteosynthesis Nailing System are provided non-sterile.
Tibial Nails are indicated for stabilization of fractures of proximal and distal tibia, tibial shaft, open and closed tibial shaft fractures, certain pre and postisthmic fractures, non-unions and malunions.
Femoral Nails are indicated for stabilization of femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions.
The Elastic Nails are indicated for fixation of diaphyseal fractures of the long bones where the medullary canal is narrow or the flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in paediatric or small statured patients. In paediatric applications, the flexibility of the elastic intramedullary nailing allows it to be inserted at a point which avoids disruption of the bone growth plate.
All Implants are for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233150 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233150: NET BRAND Osteosynthesis Nailing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233150
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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