510(k) · Cleared
ClearedAuxein Nailing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Auxein Medical Private Limited · JDS Nail, Fixation, Bone
Cleared on Jun 10, 2020 as substantially equivalent to K962047 (Synthes (Usa), 1996) and 11 other predicates after a 320-day review. Its family tree reaches back 5 generations to 1997. 2 later devices descend from it.
- Decided
- Jun 10, 2020
- Review
- 320 days
- Class
- Class II
- Product code
- JDS
- Recalls
- None
- Predicates
- 12
Its longest line of descent runs back 5 generations to K970097 (1997). 41 ancestors in all, the oldest K871539 (1987). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 4 generations backK973240 Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997
- 3 generations backK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · Recalled
- 2 generations backK042325 Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2004 · Recalled
- 1 generation backK100238 HFN 125 Degree 9-13 MM, 180MM, HFN 130 Degree 9-13 MM, HFN RH 125…DePuy Orthopaedics, Inc. · 2010 · Recalled
- This deviceK192003 Auxein Nailing SystemAuxein Medical Private Limited · 2020
- Descendant · cites it directly · 0 of its ownK230071 Femur Reconstruction Interlocking Nail System, Femur Retrograde…Tdm Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK210792 Auxein Nailing SystemAuxein Medical Private Limited · 2021
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 |
|---|---|---|---|---|---|
| −5 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −4 | K973240 | Synthes Proximal Femoral Nail (PFN) System Modification | Synthes (Usa) | 1997 | — |
| −3 | K013563 | Long Trochanteric Nail System | DePuy Orthopaedics, Inc. | 2001 | 54 |
| −2 | K042325 | Trochanteric Nail System | DePuy Orthopaedics, Inc. | 2004 | 11 |
| −1 | K100238 | HFN 125 Degree 9-13 MM, 180MM, HFN 130 Degree 9-13 MM, HFN RH 125 Degree 9-13MM | DePuy Orthopaedics, Inc. | 2010 | 250 |
| 0 (this device) | K192003 | Auxein Nailing System | Auxein Medical Private Limited | 2020 | — |
| +1 | K230071 | Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking… | Tdm Co., Ltd. | 2024 | — |
| +1 | K210792 | Auxein Nailing System | Auxein Medical Private Limited | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2003 | 5 | 0 |
| 2004 | 7 | 0 |
| 2005 | 2 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 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? (12)
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 |
|---|---|---|---|
| * | K962047 | Titanium Cannulated Tibial Nail (TI CTN)Summary page 7…ding predicate devices. S.No. Item Description Predicate Device 1. Expert Tibia Nail K962047, SYNTHES (USA) TITANIUM CANNULATED TIBIAL NAIL (TI CTN) 2. End cap for… | 1996 |
| * | K000089 | Synthes 4.0 and 5.0 MM Locking ScrewsSummary page 7…TED TIBIAL NAIL (TI CTN) 2. End cap for Expert Tibia Nail K000089,SYNTHES (USA), Locking screws 3. Ø 4.4 mm locking bolt K040762, SYNTHES… | 2000 |
| * | K040762 | Synthes (Usa) Tibial Nail System EXSummary page 7…K000089,SYNTHES (USA), Locking screws 3. Ø 4.4 mm locking bolt K040762, SYNTHES (USA) TIBIAL NAIL SYSTEM EX Ø 4.8 mm Locking bolt, self-tapping 4. Expert Femoral Nail, Left 5. Exper… | 2004 |
| * | K040336 | Synthes (Usa) Lateral Entry Femoral Nail SystemSummary page 7…EX Ø 4.8 mm Locking bolt, self-tapping 4. Expert Femoral Nail, Left 5. Expert Femoral Nail, Right K040336, SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM 6. Ø 6.4 mm Cannulated Anti-Rotation Screw, Self-Tapping for Expert… | 2004 |
| * | K100238 | HFN 125 Degree 9-13 MM, 180MM, HFN 130 Degree 9-13 MM, HFN RH 125 Degree 9-13MMSummary page 7…r Expert Femoral Nail End Cap for Expert Femoral Nail 7. 8. 130° Anti-Rotation Ga-mma Nail, Long, Left K100238 DEPUY ORTHOPAEDICS, INC HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 M… | 2010 |
| * | K012190 | Aos Modular Femoral NailSummary page 7…HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, 9. 130° Anti-Rotation Ga-mma Nail, Long, K012190, ADVANCED ORHTOPAEDIC SOLUTION, AOS Modular Right Femoral Nail… | 2001 |
| * | K970097 | Proximal Femoral Nail (PFN) SystemSummary page 9…K192003 28 AJAX ø 4.9mm Locking Bolt, Self-Tapping 29 Ajax Cephalic Screws K970097, SYNTHES(USA) PROXIMAL FEMORAL NAIL (PFN) SYSTEM 30 End Cap (For Cephalic Screws)… | 1997 |
| * | K131548 | Synthes Trochanteric Fixation Nail - Advanced SystemSummary page 9…K970097, SYNTHES(USA) PROXIMAL FEMORAL NAIL (PFN) SYSTEM 30 End Cap (For Cephalic Screws) K131548,SYNTHES (USA), Synthes Trochanteric Fixation Nail - Advanced System, used as pr… | 2014 |
| * | K032687 | Ace Nancy NailSummary page 9…ws 31 Inner Screws for Ajax Cephalic Screws 32 Ajax Nail end cap( for cephalic Screws) 33 Titanium Elastic Nail K032687 ACE NANCY NAIL DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581… | 2003 |
| * | K120807 | Synthes Multiloc Humeral Nailing SystemSummary page 9…Nail,Cannulated 37 Ø 3.5mm Locking Bolt 38 End Cap for Reconstruction cannulated intramedullary Humeral Nail K120807, SYNTHES MULTILOC HUMERAL NAILING SYSTEM 39 Reconstruction cannulated intramedullary Humeral Nail 40 4.5 mm Locking Bol… | 2012 |
| * | K033071 | Synthes (Usa) Cannulated Titanium Humeral Nail SystemSummary page 9…41 4.5 mm proximal Screw 42 Intramedullary Cannulated Humeral Nail 43 End Cap for Intramedullary Cannulated Humeral Nail K033071,SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM 44 Compression Screw fo… | 2003 |
| * | K051557 | Trigen Retrograde Femoral, Supracondylar and Tibial NailsSummary page 10…=== K192003 45 Retrograde Femoral Nail K051557, SMITH & NEPHEW,INC TRIGEN RETROGRADE FEMORAL, SUPRACONDYLAR AND TIBIAL NAILS 46… | 2005 |
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 23 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 20 of the 41 ancestors have a recall of any class.
- Of its descendants, K230071 (Tdm Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K962047.
How does its category compare?
All JDS devicesJDS Nail, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Device Name: Auxein Nailing System are categorized to the following system: 1. Expert Tibia Nailing System 2. Expert Femoral Nailing System 3. Ga-mma Nailing System 4. AJAX Advance nailing system 5. Elastic Nailing System 6. Humeral Nailing System 7. Retrograde Nailing System INDICATION FOR USE: 1. AUXEIN Brand of Expert Tibia Nailing System- consists of variety of Bone nails and bone screws. Expert Tibia Nail System is intended to stabilize fractures of…
Read the full statement (439 words)
Device Name: Auxein Nailing System are categorized to the following system:
1. Expert Tibia Nailing System 2. Expert Femoral Nailing System 3. Ga-mma Nailing System 4. AJAX Advance nailing system 5. Elastic Nailing System 6. Humeral Nailing System 7. Retrograde Nailing System
INDICATION FOR USE:
1. AUXEIN Brand of Expert Tibia Nailing System- consists of variety of Bone nails and bone screws. Expert Tibia Nail System is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial malunions and non- unions.
2. AUXEIN Brand of Expert Femoral Nailing System -is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions.
3. AUXEIN Brand of Gamma Nailing System -The Gamma Nail with Anti -Rotation Screw is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures and combinations of these fractures, including non-union, malunion and tumor resections. The Long Nail system is additionally indicated to treat pertrochanteric fractures associated with shaft fractures, pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas, impending pathological fractures, long subtrochanteric fractures, ipsilateral femoral fractures, proximal or distal non-unions, malunions, revision procedures and tumor resections.
4. AUXEIN Brand of AJAX Advance Nailing System, end cap and screws is intended to treat stable and unstable proximal femoral fracture including Pertrochanteric fractures, Intertrochanteric fractures and High sub trochanteric fractures and combination of these fractures.
5. The AUXEIN MEDICAL's Elastic Intramedullary Nail System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is important. This includes upper extremity fractures in all patients and lower extremity fractures in children above the age of 6 years and any patient below 65 kg. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures .
6. AUXEIN Brand of Humeral Nailing System is indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures, proximal humeral fractures with diaphyseal extension, diaphyseal fractures of the humeral shaft, and impending pathologic humeral fractures.
7. AUXEIN Brand of Retrograde Nailing System This nails are indicated for simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of long bones being treated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192003 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192003: Auxein 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/K192003
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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