510(k) · Cleared
ClearedOIC Intramedullary Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthopaedic Implant Company · HWC Screw, Fixation, Bone
Cleared on Feb 13, 2023 as substantially equivalent to K183603 (Exsomed Corporation, 2019) and 3 other predicates after a 60-day review. Its family tree reaches back 8 generations to 1997.
- Decided
- Feb 13, 2023
- Review
- 60 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K970097 (1997). 40 ancestors in all, the oldest K871539 (1987). No later device cites it as a predicate yet.
- Root · 8 generations backK970097 Proximal Femoral Nail (PFN) SystemSynthes (Usa) · 1997
- 7 generations backK973240 Synthes Proximal Femoral Nail (PFN) System ModificationSynthes (Usa) · 1997
- 6 generations backK013563 Long Trochanteric Nail SystemDePuy Orthopaedics, Inc. · 2001 · Recalled
- 5 generations backK033329 Depuy Ace Universal and Troch Entry Femoral Nail SystemsDepuy, Inc. · 2003
- 4 generations backK083497 Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter…Zimmer, Inc. · 2009 · Recalled
- 3 generations backK090596 Zimmer Natural Nail System Stainless Steel Tibial Nail & Stainless…Zimmer, Inc. · 2009 · Recalled
- 2 generations backK130595 Zimmer Natural Nail System Tibial Nail and Stainless Steel Tibial NailZimmer, Inc. · 2013 · Recalled
- 1 generation backK181184 OIC Intramedullary Nail SystemThe Orthopaedic Implant Company · 2018
- This deviceK223761 OIC Intramedullary Screw SystemOrthopaedic Implant Company · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K970097 | Proximal Femoral Nail (PFN) System | Synthes (Usa) | 1997 | — |
| −7 | K973240 | Synthes Proximal Femoral Nail (PFN) System Modification | Synthes (Usa) | 1997 | — |
| −6 | K013563 | Long Trochanteric Nail System | DePuy Orthopaedics, Inc. | 2001 | 54 |
| −5 | K033329 | Depuy Ace Universal and Troch Entry Femoral Nail Systems | Depuy, Inc. | 2003 | — |
| −4 | K083497 | Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade… | Zimmer, Inc. | 2009 | 16 |
| −3 | K090596 | Zimmer Natural Nail System Stainless Steel Tibial Nail & Stainless Piriformis… | Zimmer, Inc. | 2009 | 16 |
| −2 | K130595 | Zimmer Natural Nail System Tibial Nail and Stainless Steel Tibial Nail | Zimmer, Inc. | 2013 | 3 |
| −1 | K181184 | OIC Intramedullary Nail System | The Orthopaedic Implant Company | 2018 | — |
| 0 (this device) | 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 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 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 |
|---|---|---|---|
| * | K183603 | INnate Cannulated Screw SystemSummary page 4…and Wire for Surgical Implants (UNS S31673) Comparison of Technological Characteristics (Substantial Equivalence): The primary predicate device is: Exsomed Corporation K183603 Innate Cannulated Screw System Additional predicate devices: Synthes USA K050636 Synthes 3.0mm Headless Compression Screws… | 2019 |
| * | K050636 | Synthes 3.0MM Headless Compression ScrewsSummary page 4…stics (Substantial Equivalence): The primary predicate device is: Exsomed Corporation K183603 Innate Cannulated Screw System Additional predicate devices: Synthes USA K050636 Synthes 3.0mm Headless Compression Screws Orthopaedic Implant Company K113123 OIC Cannulated Scr… | 2005 |
| * | K113123 | Oic Cannulated Screw System, Oic Sliding Hip Screw (SHS) SystemSummary page 4…Screw System Additional predicate devices: Synthes USA K050636 Synthes 3.0mm Headless Compression Screws Orthopaedic Implant Company K113123 OIC Cannulated Screw System Orthopaedic Implant Company K181184 OIC Intramedullary Nail System… | 2012 |
| * | K181184 | OIC Intramedullary Nail SystemSummary page 4…sion Screws Orthopaedic Implant Company K113123 OIC Cannulated Screw System Orthopaedic Implant Company K181184 OIC Intramedullary Nail System The OIC Intramedullary Screw System has the following similarities to those which previously rece… | 2018 |
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 26 years and passes through 6 companies; a new generation was cleared every 4.2 years on median.
- 21 of the 40 ancestors have a recall of any class.
- 3 other devices also cite its predicate K183603.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The OIC Intramedullary Screw System is indicated for the fixation of intra-articular and extra-articular fractures, malunions, non-unions or osteotomies of small bones and small bone fragments, as well as arthrodesis of small joints. The device is intended for use in adults.
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/K223761 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223761: OIC Intramedullary Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223761
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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