510(k) · Cleared
ClearedOIC Intramedullary Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthopaedic Implant Company · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jul 9, 2015 as substantially equivalent to K043431 (Howmedica Osteonics Corp., 2005) and 3 other predicates after a 118-day review. Its family tree reaches back 3 generations to 2001. 2 later devices descend from it.
- Decided
- Jul 9, 2015
- Review
- 118 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K013468 (2001). 11 ancestors in all, the oldest K003018 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK013468 Long Length Dyax NailHowmedica Osteonics Corp. · 2001 · Recalled
- 2 generations backK034002 GAMMA3 Nail SystemHowmedica Osteonics Corp. · 2004 · Recalled
- 1 generation backK043431 GAMMA3 Nail SystemHowmedica Osteonics Corp. · 2005
- This deviceK150655 OIC Intramedullary Nail SystemOrthopaedic Implant Company · 2015
- Descendant · cites it directly · 1 of its ownK181184 OIC Intramedullary Nail SystemThe Orthopaedic Implant Company · 2018
- Descendant · 2 generations on · 0 of its ownK223761 OIC Intramedullary Screw SystemOrthopaedic Implant Company · 2023
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 | K013468 | Long Length Dyax Nail | Howmedica Osteonics Corp. | 2001 | 1 |
| −2 | K034002 | GAMMA3 Nail System | Howmedica Osteonics Corp. | 2004 | 2 |
| −1 | K043431 | GAMMA3 Nail System | Howmedica Osteonics Corp. | 2005 | — |
| 0 (this device) | K150655 | OIC Intramedullary Nail System | Orthopaedic Implant Company | 2015 | — |
| +1 | K181184 | OIC Intramedullary Nail System | The Orthopaedic Implant Company | 2018 | — |
| +2 | K223761 | OIC Intramedullary Screw System | Orthopaedic Implant Company | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K043431 | GAMMA3 Nail SystemSummary page 4…ndition will be sterilized with gamma radiation in accordance with methods and protocols outlined in ISO 11137-1:2006. Substantial Equivalence Primary predicate device: K043431 Gamma 3 Nail System Additional predicate devices: K101438 T2 Greater Trochanter Nail (GTN) K112059 T2… | 2005 |
| * | K101438 | T2 Greater Trochanter NailSummary page 4…methods and protocols outlined in ISO 11137-1:2006. Substantial Equivalence Primary predicate device: K043431 Gamma 3 Nail System Additional predicate devices: K101438 T2 Greater Trochanter Nail (GTN) K112059 T2 Femoral Nail K003018 Titan Tibial Nail Reference device: K… | 2010 |
| * | K112059 | T2 Femoral Nail Model 1825-Xxxxcp, 1828-XxxxcpSummary page 4…. Substantial Equivalence Primary predicate device: K043431 Gamma 3 Nail System Additional predicate devices: K101438 T2 Greater Trochanter Nail (GTN) K112059 T2 Femoral Nail K003018 Titan Tibial Nail Reference device: K131548 Synthes Trochanteric Fixation Nail… | 2011 |
| * | K003018 | Titan Tibial NailSummary page 4…y predicate device: K043431 Gamma 3 Nail System Additional predicate devices: K101438 T2 Greater Trochanter Nail (GTN) K112059 T2 Femoral Nail K003018 Titan Tibial Nail Reference device: K131548 Synthes Trochanteric Fixation Nail - Advanced System The new devic… | 2000 |
| † | K131548 | Synthes Trochanteric Fixation Nail - Advanced System | 2014 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181184 | OIC Intramedullary Nail System | 2018 | 1 |
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 14 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- 6 of the 11 ancestors have a recall of any class.
- Of its descendants, K181184 (The Orthopaedic Implant Company, 2018) has gone furthest, with 1 descendant of its own.
- 15 other devices also cite its predicate K043431.
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. 2015, 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/K150655 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150655: 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/K150655
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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