510(k) · Cleared
ClearedOIC Intramedullary Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Orthopaedic Implant Company · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jul 27, 2018 as substantially equivalent to K150655 (Orthopaedic Implant Company, 2015) and 1 other predicate after an 85-day review. Its family tree reaches back 7 generations to 1997. 1 later device descends from it.
- Decided
- Jul 27, 2018
- Review
- 85 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K970097 (1997). 34 ancestors in all, the oldest K871539 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 6 generations backK973240 Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997
- 5 generations backK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · Recalled
- 4 generations backK033329 Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc. · 2003
- 3 generations backK083497 Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter…Zimmer, Inc. · 2009 · Recalled
- 2 generations backK090596 Zimmer Natural Nail System Stainless Steel Tibial Nail & Stainless…Zimmer, Inc. · 2009 · Recalled
- 1 generation backK130595 Zimmer Natural Nail System Tibial Nail and Stainless Steel Tibial NailZimmer, Inc. · 2013 · Recalled
- This deviceK181184 OIC Intramedullary Nail SystemThe Orthopaedic Implant Company · 2018
- Descendant · cites it directly · 0 of its ownK223761 OIC Intramedullary Screw SystemOrthopaedic Implant Company · 2023
Most influential descendants
Showing 1 of 1 · See all- K223761OIC Intramedullary Screw SystemOrthopaedic Implant Company · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −6 | K973240 | Synthes Proximal Femoral Nail (PFN) System Modification | Synthes (Usa) | 1997 | — |
| −5 | K013563 | Long Trochanteric Nail System | DePuy Orthopaedics, Inc. | 2001 | 54 |
| −4 | K033329 | Depuy Ace Universal and Troch Entry Femoral Nail Systems | Depuy, Inc. | 2003 | — |
| −3 | K083497 | Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade… | Zimmer, Inc. | 2009 | 16 |
| −2 | K090596 | Zimmer Natural Nail System Stainless Steel Tibial Nail & Stainless Piriformis… | Zimmer, Inc. | 2009 | 16 |
| −1 | K130595 | Zimmer Natural Nail System Tibial Nail and Stainless Steel Tibial Nail | Zimmer, Inc. | 2013 | 3 |
| 0 (this device) | K181184 | OIC Intramedullary Nail System | The Orthopaedic Implant Company | 2018 | — |
| +1 | K223761 | OIC Intramedullary Screw System | Orthopaedic Implant Company | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (2)
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 |
|---|---|---|---|
| * | K150655 | OIC Intramedullary Nail SystemSummary page 4…on. They are made of surgical grade stainless steel or 6061-T6 Aluminum with a medical grade silicone or Radel handle. Substantial Equivalence Primary predicate device: K150655 OIC Intramedullary Nail System Additional predicate devices: K130595 System Modification - ZNN System Tibial Na… | 2015 |
| * | K130595 | Zimmer Natural Nail System Tibial Nail and Stainless Steel Tibial NailSummary page 4…medical grade silicone or Radel handle. Substantial Equivalence Primary predicate device: K150655 OIC Intramedullary Nail System Additional predicate devices: K130595 System Modification - ZNN System Tibial Nail and Stainless Steel Tibial Nail The new device is substantially equivalent… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223761 | OIC Intramedullary Screw System | 2023 | 0 |
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 21 years and passes through 5 companies; a new generation was cleared every 4.1 years on median.
- 19 of the 34 ancestors have a recall of any class.
- Of its descendants, K223761 (Orthopaedic Implant Company, 2023) has gone furthest, with 0 descendants of its own.
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. 2018, 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 OIC Intramedullary Nail System is intended for surgical management of femoral and tibial fractures including open and closed fractures, pseudarthrosis and correction osteotomy, pathologic fractures, impending pathologic fractures, tumor resections, nonunions and malunions. The hip nails may be used for basilar neck, subtrochanteric and intertrochanteric fractures. The femoral nails may be used for fractures of the femur below the hip joint including ipsilateral femur fractures, fractures proximal to a total knee arthroplasty and supracondylar fractures, including those with intra-articular extension.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181184 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181184: OIC Intramedullary 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/K181184
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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