510(k) · Cleared
ClearedDePuy Synthes Trauma Orthopedic Nail Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Synthes · HRS Plate, Fixation, Bone
Cleared on Dec 26, 2018 as substantially equivalent to K000972 (Synthes (Usa), 2000) and 27 other predicates after an 86-day review. Its family tree reaches back 3 generations to 1998. 2 later devices descend from it.
- Decided
- Dec 26, 2018
- Review
- 86 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 28
Its longest line of descent runs back 3 generations to K981529 (1998). 35 ancestors in all, the oldest K914371 (1992). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK981529 Titanium Intramedullary Nail, Titanium Locking ScrewSmith & Nephew, Inc. · 1998 · Recalled
- 2 generations backK040212 Trigen IntertanSmith & Nephew, Inc. · 2004 · Recalled
- 1 generation backK120083 Set Screw for TI Trochanteric Fixation Nail (TFN)Synthes USA · 2012
- This deviceK182783 DePuy Synthes Trauma Orthopedic Nail ImplantsDePuy Synthes · 2018
- Descendant · cites it directly · 0 of its ownK253155 Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK201830 ANSER Clavicle PinBAAT Medical Products B.V. · 2020
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 |
|---|---|---|---|---|---|
| −3 | K981529 | Titanium Intramedullary Nail, Titanium Locking Screw | Smith & Nephew, Inc. | 1998 | 2 |
| −2 | K040212 | Trigen Intertan | Smith & Nephew, Inc. | 2004 | 6 |
| −1 | K120083 | Set Screw for TI Trochanteric Fixation Nail (TFN) | Synthes USA | 2012 | — |
| 0 (this device) | K182783 | DePuy Synthes Trauma Orthopedic Nail Implants | DePuy Synthes | 2018 | — |
| +1 | K253155 | Fule Metallic Lockable Intramedullary Nail Systems | Beijing Fule Science & Technology Development Co., Ltd. | 2026 | — |
| +1 | K201830 | ANSER Clavicle Pin | BAAT Medical Products B.V. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2026 | 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? (28)
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 |
|---|---|---|---|
| * | K000972 | Synthes (Usa) Trochanter Stabilization Plate for DHSSummary page 32…liance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Regulatory Class: Class II; 888.3030 Product Code(s): LXT 1.3. Predicate Device K000972 SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS 1.4. Device Description The DePuy Synthes Trochanter Stabilization Plate… | 2000 |
| * | K002710 | Modification to Synthes (Usa) Trochanter Stabilization Plate (TSB) for DHS (Line…Summary page 34…ine Extension) – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): HRS, N/A 1.3. Predicate Device K002710 Modification to Synthes (USA) Trochanter Stabilization Plate (TSP) for DHS (Line Extension) 1.4. Device Description The DePuy… | 2000 |
| * | K002729 | Synthes Proximal Humeral NailSummary page 36…al Humeral Nail – MR Conditional Classification Name(s): Nail, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): JDS, N/A 1.3. Predicate Device K002729 Synthes (USA) Proximal Humeral Nail 1.4. Device Description The DePuy Synthes Proximal Humeral Nail is an intramedullary rod… | 2000 |
| * | K011857 | Synthes (Usa) Trochanteric Fixation Nail (TFN) SystemSummary page 38…itional Classification Name(s): Rod, Fixation, Intramedullary And Accessories Regulatory Class: Class II; 888.3020 Product Code(s): HSB, HWC 1.3. Predicate Device K011857 Synthes (USA) Trochanteric Fixation Nail (TFN) System 1.4. Device Description The DePuy Synthes Trochanteric Fixation Nail (T… | 2001 |
| * | K033618 | Synthes (Usa) Retrograde/Antegrade Femoral Nail SystemSummary page 40…itional Classification Name(s): Rod, Fixation, Intramedullary And Accessories Regulatory Class: Class II; 888.3020 Product Code(s): HSB, HWC 1.3. Predicate Device K033618 Synthes (USA) Retrograde/Antegrade Femoral Nail System 1.4. Device Description The DePuy Synthes Retrograde/Antegrade Femoral… | 2004 |
| * | K040336 | Synthes (Usa) Lateral Entry Femoral Nail SystemSummary page 42…itional Classification Name(s): Rod, Fixation, Intramedullary And Accessories Regulatory Class: Class II; 888.3020 Product Code(s): HSB, N/A 1.3. Predicate Device K040336 Synthes (USA) Lateral Entry Femoral Nail System 1.4. Device Description The DePuy Synthes Lateral Entry Femoral Nail System i… | 2004 |
| * | K042135 | Synthes (Usa) Elastic Intramedullary Nail (Ein) System (Line Extension)Summary page 44…itional Classification Name(s): Rod, Fixation, Intramedullary And Accessories Regulatory Class: Class II; 888.3020 Product Code(s): HSB, N/A 1.3. Predicate Device K042135 Synthes (USA) Elastic Intramedullary Nail (EIN) System (Line Extension) 1.4. Device Description The DePuy Synthes Elastic Int… | 2004 |
| * | K042895 | Synthes LCP Dynamic Helical Hip System, Additional Helix BladesSummary page 46…Name(s): Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Regulatory Class: Class II; 888.3030 Product Code(s): KTT, N/A 1.3. Predicate Device K042895 Synthes LCP Dynamic Helical Hip System, Additional Helix Blades 1.4. Device Description The DePuy Synthes LCP Dynamic Helical… | 2004 |
| * | K051678 | Synthes Hindfoot Arthrodesis Nail SystemSummary page 48…itional Classification Name(s): Rod, Fixation, Intramedullary And Accessories Regulatory Class: Class II; 888.3020 Product Code(s): HSB, N/A 1.3. Predicate Device K051678 Synthes Hindfoot Arthrodesis Nail System 1.4. Device Description The DePuy Synthes Hindfoot Arthrodesis Nail System is compos… | 2005 |
| * | K052677 | Synthes Universal Locking Trochanter Stabilization Plate (Ultsp)Summary page 50…Plate (ULTSP) – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): HRS, N/A 1.3. Predicate Device K052677 Synthes Universal Locking Trochanter Stabilization Plate (ULTSP) 1.4. Device Description The DePuy Synthes Universal Locking… | 2005 |
| * | K070294 | Synthes Trochanteric Fixation Nail (TFN) System, Additional Helical BladesSummary page 52…itional Classification Name(s): Rod, Fixation, Intramedullary And Accessories Regulatory Class: Class II; 888.3020 Product Code(s): HSB, HWC 1.3. Predicate Device K070294 Synthes Trochanteric Fixation Nail (TFN) System, Additional Helical Blades 1.4. Device Description The DePuy Synthes Trochant… | 2007 |
| * | K070843 | Synthes Adolescent Lateral Entry Femoral Nail SystemSummary page 54…itional Classification Name(s): Rod, Fixation, Intramedullary And Accessories Regulatory Class: Class II; 888.3020 Product Code(s): HSB, N/A 1.3. Predicate Device K070843 Synthes Adolescent Lateral Entry Femoral Nail System 1.4. Device Description The DePuy Synthes Adolescent Lateral Entry Femor… | 2007 |
| * | K073402 | Synthes Olecranon Osteotomy Nailing SystemSummary page 56…itional Classification Name(s): Rod, Fixation, Intramedullary And Accessories Regulatory Class: Class II; 888.3020 Product Code(s): HSB, N/A 1.3. Predicate Device K073402 Synthes Olecranon Osteotomy Nailing System 1.4. Device Description The DePuy Synthes Olecranon Osteotomy Nailing System consi… | 2008 |
| * | K092646 | Synthes (Usa) Trochanteric Fixation Nail (TFN) ScrewSummary page 58…itional Classification Name(s): Rod, Fixation, Intramedullary And Accessories Regulatory Class: Class II; 888.3020 Product Code(s): HSB, HWC 1.3. Predicate Device K092646 Synthes (USA) Trochanteric Fixation Nail (TFN) Screw 1.4. Device Description The DePuy Synthes Trochanteric Fixation Nail (TF… | 2009 |
| * | K120083 | Set Screw for TI Trochanteric Fixation Nail (TFN)Summary page 60…itional Classification Name(s): Rod, Fixation, Intramedullary And Accessories Regulatory Class: Class II; 888.3020 Product Code(s): HSB, HWC 1.3. Predicate Device K120083 Set Screw for Ti Trochanteric Fixation Nail (TFN) 1.4. Device Description The DePuy Synthes Set Screw for Ti Trochanteric Fix… | 2012 |
| * | K131548 | Synthes Trochanteric Fixation Nail - Advanced SystemSummary page 62…itional Classification Name(s): Rod, Fixation, Intramedullary And Accessories Regulatory Class: Class II; 888.3020 Product Code(s): HSB, N/A 1.3. Predicate Device K131548 Synthes Trochanteric Fixation Nail ‐ Advanced System 1.4. Device Description The DePuy Synthes Trochanteric Fixation Nail ‐ A… | 2014 |
| * | K914371 | Universal Femoral NailSummary page 64…al Femoral Nail – MR Conditional Classification Name(s): Nail, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): JDS, N/A 1.3. Predicate Device K914371 Universal Femoral Nail 1.4. Device Description The DePuy Synthes Universal Femoral Nail, regardless of whether Synthes provid… | 1992 |
| * | K914453 | Universal Tibial Nail and Unreamed Tibial NailSummary page 66…med Tibial Nail – MR Conditional Classification Name(s): Nail, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): JDS, N/A 1.3. Predicate Device K914453 Universal Tibial Nail and Unreamed Tibial Nail 1.4. Device Description The DePuy Synthes Universal Tibial Nail is made from s… | 1992 |
| * | K923580 | Synthes TI-6AI-7NB Unreamed Femoral NailSummary page 68…itional Classification Name(s): Rod, Fixation, Intramedullary And Accessories Regulatory Class: Class II; 888.3020 Product Code(s): HSB, N/A 1.3. Predicate Device K923580 Synthes TI‐6AL‐7NB Unreamed Femoral Nail 1.4. Device Description The DePuy Synthes TI‐6AI‐7NB Unreamed Femoral Nail is intend… | 1993 |
| * | K932330 | TI-6AL-7NB UrtnSummary page 70…itional Classification Name(s): Rod, Fixation, Intramedullary And Accessories Regulatory Class: Class II; 888.3020 Product Code(s): HSB, N/A 1.3. Predicate Device K932330 TI‐6AL‐7NB Unreamed Tibial Nail (URTN) 1.4. Device Description The DePuy Synthes TI‐6AL‐7NB Unreamed Tibial Nail (URTN) is in… | 1996 |
| * | K932593 | Access to Synthes TI-6A1-7NB Unreamed Femoral NailSummary page 72…onal Classification Name(s): Rod, Fixation, Intramedullary And Accessories Regulatory Class: Class II; 888.3020 Product Code(s): HSB, N/A 1.3. Predicate Device K932593 Accessories to Titanium Alloy Unreamed Femoral Nail (URFN) 1.4. Device Description The Accessories to DePuy Synthes Titani… | 1994 |
| * | K933518 | Synthes Unreamed Humeral Nail (Urhn)Summary page 74…itional Classification Name(s): Rod, Fixation, Intramedullary And Accessories Regulatory Class: Class II; 888.3020 Product Code(s): HSB, N/A 1.3. Predicate Device K933518 Synthes Unreamed Humeral Nail (URHN) 1.4. Device Description The DePuy Synthes Unreamed Humeral Nail (URHN) has a 5° bend pos… | 1994 |
| * | K954856 | Cannulated Femoral NailSummary page 76…itional Classification Name(s): Rod, Fixation, Intramedullary And Accessories Regulatory Class: Class II; 888.3020 Product Code(s): HSB, JDS 1.3. Predicate Device K954856 Cannulated Femoral Nail 1.4. Device Description The DePuy Synthes Cannulated Femoral Nail (CFN) is a cannulated, locking intr… | 1996 |
| * | K962047 | Titanium Cannulated Tibial Nail (TI CTN)Summary page 78…l Nail (TI CTN) – MR Conditional Classification Name(s): Nail, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): JDS, N/A 1.3. Predicate Device K962047 Titanium Cannulated Tibial Nail (TI CTN) 1.4. Device Description The DePuy Synthes Titanium Cannulated Tibial Nail (TI CTN) i… | 1996 |
| * | K970097 | Proximal Femoral Nail (PFN) SystemSummary page 80…(PFN) System – MR Conditional Classification Name(s): Pin, Fixation, Threaded Regulatory Class: Class II; 888.3040 Product Code(s): JDW, JDS 1.3. Predicate Device K970097 Proximal Femoral Nail (PFN) System 1.4. Device Description The DePuy Synthes Proximal Femoral Nail (PFN) System is an intrame… | 1997 |
| * | K970733 | Synthes Titanium Diastal Femoral Nail (TI DFN) SystemSummary page 82…(TI DFN) System – MR Conditional Classification Name(s): Pin, Fixation, Smooth Regulatory Class: Class II; 888.3040 Product Code(s): HTY, N/A 1.3. Predicate Device K970733 Synthes Titanium Distal Femoral Nail (TI DFN) System 1.4. Device Description The DePuy Synthes Titanium Distal Femoral Nail (… | 1997 |
| * | K971783 | Synthes Elastic Intramedullary Nail (Ein) SystemSummary page 84…l (EIN) System – MR Conditional Classification Name(s): Pin, Fixation, Smooth Regulatory Class: Class II; 888.3040 Product Code(s): HTY, N/A 1.3. Predicate Device K971783 Synthes Elastic Intramedullary Nail (EIN) System 1.4. Device Description The DePuy Synthes Elastic Intramedullary Nail (EIN)… | 1997 |
| * | K992348 | Synthes Spiral Blade for Humeral Nail (SBHN)Summary page 86…ral Nail (SBHN) – MR Conditional Classification Name(s): Nail, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): JDS, N/A 1.3. Predicate Device K992348 Synthes Spiral Blade for Humeral Nail (SBHN) 1.4. Device Description The DePuy Synthes Spiral Blade for Humeral Nail (SBHN) i… | 1999 |
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 20 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- 11 of the 35 ancestors have a recall of any class.
- Of its descendants, K253155 (Beijing Fule Science & Technology Development Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K000972.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
The DePuy Synthes Trochanter Stabilization Plate (TSP) for DHS is intended to treat stable and unstable intertrochanteric, subtrochanteric, pertrochanteric and basilar neck fractures when used in conjunction with the DePuy Synthes Dynamic Hip Screw (DHS) plating system. The DePuy Synthes Trochanter Stabilization Plate (TSP) for the Dynamic Hip Screw System (DHS®) is intended to treat stable and unstable intertrochanteric, subtrochanteric, pertrochanteric…
Read the full statement (1,500 words)
The DePuy Synthes Trochanter Stabilization Plate (TSP) for DHS is intended to treat stable and unstable intertrochanteric, subtrochanteric, pertrochanteric and basilar neck fractures when used in conjunction with the DePuy Synthes Dynamic Hip Screw (DHS) plating system.
The DePuy Synthes Trochanter Stabilization Plate (TSP) for the Dynamic Hip Screw System (DHS®) is intended to treat stable and unstable intertrochanteric, subtrochanteric, pertrochanteric and basilar neck fractures when used in conjunction with the DHS® System.
The DePuy Synthes Proximal Humeral Nail is intended for use in fractures of the proximal humerus.
The DePuy Synthes Trochanteric Fixation Nail (TFN) System is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The Long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.
The DePuy Synthes Retrograde/Antegrade Femoral Nail System is intended to stabilize fractures of the distal femur and the femoral shaft, including:
• supracondylar fractures, including those with intra-articular extension;
• ipsilateral hip/shaft fractures;
• ipsilateral femur/tibia fractures;
• femoral fractures in multiple trauma patients;
• fractures proximal to total knee arthroplasty;
• fractures distal to a hip implant;
• fractures in the morbidly obese;
• fractures in osteoporotic bone, impending pathologic fractures;
• malunions and nonunions
The DePuy Synthes Lateral Entry Femoral Nail System is intended to stabilize femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions.
The DePuy Synthes Elastic Intramedullary Nail (EIN) System (Line Extension) is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate.
The DePuy Synthes LCP Dynamic Helical Hip System, Additional Helix Blades is intended to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed.
The DePuy Synthes Hindfoot Arthrodesis Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include, but are not limited to Neuro-osteoarthropathy (Charcot's Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture non-unions, Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis.
The DePuy Synthes Universal Locking Trochanter Stabilization Plate (ULTSP) for DHS or LCP DHHS is intented to treat stable and unstable intertrochanteric, subtrochanteric, pertrochanteric and basilar neck fractures when used in conjunction with the Synthes Dynamic Hip Screw (DHS) or the LCP Dynamic Helical Hip System (DHHS) side plates with four or more holes.
The DePuy Synthes Trochanteric Fixation Nail (TFN) System, Additional Helical Blades is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The Long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.
The DePuy Synthes Adolescent Lateral Entry Femoral Nail System will be intended to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, impending pathologic fractures, non-unions and malunions in adolescent and small stature adult patients.
The DePuy Synthes Olecranon Osteotomy Nailing (OleON) System is intended to treat olecranlon osteotomies as well as simple fractures of the olecranon.
As part of the DePuy Synthes Trochanteric Fixation Nail (TFN) System, the DePuy Synthes Trochanteric Fixation Nail (TFN) Screw is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The Long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.
The DePuy Synthes Set Screw for Ti Trochanteric Fixation Nail (TFN) is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures and combinations thereof. The long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.
The DePuy Synthes Trochanteric Fixation Nail - Advanced (TFNA) System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused. Specifically, the system is indicated for:
• Stable and unstable pertrochanteric fractures
• Intertrochanteric fractures
• Basal neck fractures
• Combinations of pertrochanteric, intertrochanteric and basal neck fractures
The Long Nail is additionally intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused for the following indications:
• Subtrochanteric fractures
• Pertrochanteric fractures associated with shaft fractures
• Pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions
• Long Subtrochanteric fractures
• Proximal or distal non-unions, malunions and revisions
The DePuy Synthes Universal Femoral Nail is intended for use in stabilizing fractures of the femur. More specifically, the primary intended use is stable midshaft (diaphyseal) femoral fracture and hypertrophic pseudarthrosis (non-union) or unstable femoral fracture stabilization.
The DePuy Synthes Universal Tibial Nail and the DePuy Synthes Unreamed Tibial Nail are intended for use in stabilizing fractures of the tibia. More specifically, the primary intended use of the Universal Tibial Nail is stable diaphyseal fractures or long or rotationally-unstable diaphyseal fractures, including rotationally unstable proximal and distal diaphyseal fractures. For the Unreamed Tibial Nail, the specific intended uses are Grade I and II open tibial diaphyseal fractures; high energy, unstable, closed fracture patterns; comminuted fractures of tibias with small medullary canals; and certain pre- and postisthmic fractures.
The DePuy Synthes TI-6AI-7NB Unreamed Femoral Nail is intended for use in stabilizing fractures of the femur. Specific Indications: Acute femoral diaphyseal fractures; post-isthmic femoral fractures; subtrochanteric femoral fractures.
The DePuy Synthes TI-6AL-7NB Unreamed Tibial Nail (URTN) is intended to stabilize fractures of the tibia. Specifically, it is intended for grade I and II open tibial diaphyseal fractures; high energy, unstable, closed fracture patterns; comminuted fractures of tibiae with small medullary canals; and certain pre- and post-isthmic fractures.
The accessories are intended for use with the DePuy Synthes Titanium Alloy Unreamed Femoral Nail (URFN), which is intended for use in stabilizing fractures of the femur. The Synthes Twisted Blade and 5.0 mm Shaft Screw, used with the Locking Sleeve and End Cap, are intended to transmit load between the bone and the URFN to prevent rotation and displacement of the nail/fracture when stabilizing subtrochanteric femoral fractures (short, long, reverse oblique and comminuted).
The DePuy Synthes Unreamed Humeral Nail (URHN) is intended to stabilize fractures of the humerus. It is specifically indicated for acute humeral shaft fractures, pathologic or impending pathologic fractures of the humeral shaft, and non- and mal unions of the humeral shaft.
The DePuy Synthes Cannulated Femoral Nail (CFN) is intended to stabilize fractures of the femur. Specifically, the primary intended use is acute femoral diaphyseal fractures, post-isthmic femoral fractures, subtrochanteric femoral fractures, non-unions and impending pathological fractures.
The DePuy Synthes Titanium Cannulated Tibial Nail (TI CTN) is intended to stabilize fractures of the tibia. Indications include, but are not limited to, open and closed tibial shaft fractures, certain pre- and post-isthmic fractures, tibial malunions and tibial non-unions.
The DePuy Synthes Proximal Femoral Nail (PFN) System is intended to treat stable and unstable proximal femoral fractures including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures, and combinations of these fractures.
The DePuy Synthes Titanium Distal Femoral Nail (TI DFN) System is generally intended to stabilize fractures of the distal femur. Specifically, the Ti DFN is intended for supracondylar fractures (including those with intra-articular and/or extra-articular involvement), pathologic fractures, mal-unions, non-unions, ipsilateral hip/shaft fractures, ipsilateral femur/tibia fractures, fractures proximal to a total knee, fractures distal to a total hip, fractures in the multiply injured patient, fractures in the morbidly obese patient, and fractures in osteoporotic bane. The Ti DFN can be used in either reamed or non-reamed applications.
The DePuy Synthes Elastic Intramedullary Nail (EIN) System is intended for fixation of diaphyseal fractures of the long bones where the medullary canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-statured patients. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate.
The DePuy Synthes Spiral Blade for Humeral Nail (SBHN) is intended to stabilize fractures of the humerus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182783 · printed Nov 6, 2026
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510(k) Report. “K182783: DePuy Synthes Trauma Orthopedic Nail Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182783
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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