510(k) · Cleared
ClearedINnate Cannulated Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exsomed Corporation · HWC Screw, Fixation, Bone
Cleared on Mar 12, 2019 as substantially equivalent to K171558 (Exsomed Holdings Company, LLC, 2017) and 1 other predicate after a 76-day review. Its family tree reaches back 2 generations to 2000. 5 later devices descend from it.
- Decided
- Mar 12, 2019
- Review
- 76 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K000080 (2000). 3 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK000080 Asnis Iii Cannulated Screw SystemHowmedica Osteonics Corp. · 2000 · Recalled
- 1 generation backK171558 ExsoMed ITN Cannulated Screw SystemExsomed Holdings Company, LLC · 2017
- This deviceK183603 INnate Cannulated Screw SystemExsomed Corporation · 2019
- Descendant · cites it directly · 1 of its ownK201430 InFrame™ Cannulated Fixation SystemExsomed Corp. · 2020
- Descendant · cites it directly · 0 of its ownK252312 Eleganz IM Threaded Nail System (IM Threaded Nail System)Dev4 · 2025
- Descendant · cites it directly · 0 of its ownK223761 OIC Intramedullary Screw SystemOrthopaedic Implant Company · 2023
- Descendant · cites it directly · 0 of its ownK222799 Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices · 2023
- Descendant · 2 generations on · 0 of its ownK220892 ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp. · 2022
Most influential descendants
Showing 5 of 5 · See all- K201430InFrame™ Cannulated Fixation SystemExsomed Corp. · 2020 · cites it directly1descendant
- K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)Dev4 · 2025 · cites it directly0descendants
- K223761OIC Intramedullary Screw SystemOrthopaedic Implant Company · 2023 · cites it directly0descendants
- K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices · 2023 · cites it directly0descendants
- K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000080 | Asnis Iii Cannulated Screw System | Howmedica Osteonics Corp. | 2000 | 1 |
| −1 | K171558 | ExsoMed ITN Cannulated Screw System | Exsomed Holdings Company, LLC | 2017 | — |
| 0 (this device) | K183603 | INnate Cannulated Screw System | Exsomed Corporation | 2019 | — |
| +1 | K201430 | InFrame™ Cannulated Fixation System | Exsomed Corp. | 2020 | — |
| +1 | K252312 | Eleganz IM Threaded Nail System (IM Threaded Nail System) | Dev4 | 2025 | — |
| +1 | K223761 | OIC Intramedullary Screw System | Orthopaedic Implant Company | 2023 | — |
| +1 | K222799 | Haymaker® Screw System | Orthocircle Spine D.B.A. OC Medical Devices | 2023 | — |
| +2 | K220892 | ExsoMed INnate NanoTM Lag Screw System | Exsomed Corp. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K171558 | ExsoMed ITN Cannulated Screw SystemSummary page 4…fastener Classification: 21 CFR 888.3040 Classification: Class II Product Code: HWC PREDICATE DEVICES Primary Predicate: ExsoMed™ ITN Cannulated Screw System K Number: K171558 Clearance Date: 09/01/17 Secondary Predicate: Synthes 3.0mm Headless Compression Screws K Number: K050636 Clearance Date: 04/21/… | 2017 |
| * | K050636 | Synthes 3.0MM Headless Compression ScrewsSummary page 4…mary Predicate: ExsoMed™ ITN Cannulated Screw System K Number: K171558 Clearance Date: 09/01/17 Secondary Predicate: Synthes 3.0mm Headless Compression Screws K Number: K050636 Clearance Date: 04/21/2005 ExsoMed Corporation Special 510(k)… | 2005 |
What descends from it? (5)
4 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 19 years and passes through 3 companies; a new generation was cleared every 17.4 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K201430 (Exsomed Corp., 2020) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K171558.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 ExsoMed INnate Cannulated Screw System is intended for fixation of intra-articular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodesis of small joints; bunionectomies and osteotomies, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
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/K183603 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183603: INnate Cannulated 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/K183603
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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