510(k) · Cleared
ClearedEmerge Medical IM Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emerge Medical · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Oct 2, 2014 as substantially equivalent to K081152 (Howmedica Osteonics Corp., 2008) and 4 other predicates after a 133-day review. Its family tree reaches back 12 generations to 1996.
- Decided
- Oct 2, 2014
- Review
- 133 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 12 generations to K962616 (1996). 100 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 8 generations between
- 3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 2 generations backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- 1 generation backK122489 Emerge Medical Solid Bone ScrewsEmerge Medical · 2012
- This deviceK141347 Emerge Medical IM Nail SystemEmerge Medical · 2014
Show all 12 generations
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 11 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 10 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 9 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 8 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 7 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 6 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 5 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 4 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 2 generations backK112583 Synthes Cortical ScrewsSynthes (USA) Products, LLC · 2011
- 1 generation backK122489 Emerge Medical Solid Bone ScrewsEmerge Medical · 2012
- This deviceK141347 Emerge Medical IM Nail SystemEmerge Medical · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −11 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −10 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −9 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −8 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −7 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −6 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −5 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −4 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −3 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −2 | K112583 | Synthes Cortical Screws | Synthes (USA) Products, LLC | 2011 | — |
| −1 | K122489 | Emerge Medical Solid Bone Screws | Emerge Medical | 2012 | — |
| 0 (this device) | K141347 | Emerge Medical IM Nail System | Emerge Medical | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 6 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 10 | 0 |
| 2001 | 10 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 7 | 0 |
| 2005 | 5 | 0 |
| 2006 | 8 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 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 HSB? 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 HSB device
- #1 K200869 Gamma3 Systemscore 19.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K081152 | T2 Femoral NailSummary page 4…or Humeral Fractures according to Neer-Classification. MATERIALS: Titanium alloy (ASTM F136) PREDICATE DEVICES: Stryker IM Nails (K081152, K003018, K043404); Emerge Medical Screws (K122489, K140119) TECHNOLOGIC The fundamental scien… | 2008 |
| * | K003018 | Titan Tibial NailSummary page 4…l Fractures according to Neer-Classification. MATERIALS: Titanium alloy (ASTM F136) PREDICATE DEVICES: Stryker IM Nails (K081152, K003018, K043404); Emerge Medical Screws (K122489, K140119) TECHNOLOGIC The fundamental scientific pri… | 2000 |
| * | K043404 | Modification to T2 Proximal Humeral NailSummary page 4…es according to Neer-Classification. MATERIALS: Titanium alloy (ASTM F136) PREDICATE DEVICES: Stryker IM Nails (K081152, K003018, K043404); Emerge Medical Screws (K122489, K140119) TECHNOLOGIC The fundamental scientific principles a… | 2004 |
| * | K122489 | Emerge Medical Solid Bone ScrewsSummary page 4…on. MATERIALS: Titanium alloy (ASTM F136) PREDICATE DEVICES: Stryker IM Nails (K081152, K003018, K043404); Emerge Medical Screws (K122489, K140119) TECHNOLOGIC The fundamental scientific principles and technological CHARACTERISTICS: characteristics,… | 2012 |
| * | K140119 | Emerge Medical Periarticular and Locking Large Fragment SystemSummary page 4…IALS: Titanium alloy (ASTM F136) PREDICATE DEVICES: Stryker IM Nails (K081152, K003018, K043404); Emerge Medical Screws (K122489, K140119) TECHNOLOGIC The fundamental scientific principles and technological CHARACTERISTICS: characteristics, includin… | 2014 |
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 18 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 22 of the 100 ancestors have a recall of any class.
- 5 other devices also cite its predicate K081152.
How does its category compare?
All HSB devicesHSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · HSB
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSB
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSB
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSB
2,911in 2025
MAUDE reports naming product code HSB, 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 | 8 | 68 | 0 | 162 |
| 2008 | 11 | 57 | 9 | 184 |
| 2009 | 18 | 86 | 81 | 334 |
| 2010 | 14 | 117 | 18 | 454 |
| 2011 | 16 | 78 | 2 | 662 |
| 2012 | 17 | 112 | 7 | 1,079 |
| 2013 | 18 | 105 | 14 | 1,773 |
| 2014 | 19 | 147 | 3 | 1,474 |
| 2015 | 22 | 111 | 3 | 1,671 |
| 2016 | 8 | 124 | 6 | 1,920 |
| 2017 | 23 | 119 | 66 | 1,447 |
| 2018 | 17 | 134 | 56 | 3,526 |
| 2019 | 13 | 132 | 6 | 2,517 |
| 2020 | 17 | 112 | 6 | 3,299 |
| 2021 | 10 | 94 | 2 | 4,111 |
| 2022 | 12 | 172 | 1 | 2,733 |
| 2023 | 11 | 162 | 1 | 2,219 |
| 2024 | 13 | 195 | 1 | 2,869 |
| 2025 | 15 | 106 | 18 | 2,911 |
| 2026 | 18 | 151 | 1 | — |
What is it indicated for?
The Emerge Medical IM Nail System is intended to provide temporary stabilization in long bones including the femur, tibia and humerus of various types of open or closed fractures including malunions, nonunions (pseudoarthrosis), correction osteotomy including malalignment, pathologic fractures, impending pathologic fractures, and tumor resections of specific bones. Specific Femoral indications may include supracondylar fractures, including those with…
Read the full statement (105 words)
The Emerge Medical IM Nail System is intended to provide temporary stabilization in
long bones including the femur, tibia and humerus of various types of open or closed
fractures including malunions, nonunions (pseudoarthrosis), correction osteotomy
including malalignment, pathologic fractures, impending pathologic fractures, and tumor
resections of specific bones.
Specific Femoral indications may include supracondylar fractures, including those with
intra-articular extension, Ipsilateral femur fractures, fractures proximal to a total knee
arthroplasty, and fractures distal to a hip joint.
Specific Humeral indications according to AO classification may include Type A-
Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact
calotte, or Humeral Fractures according to Neer-Classification.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141347 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141347: Emerge Medical IM Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141347
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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