510(k) · Cleared
ClearedAcumed Acutrak 3 Headless Compression Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acumed, LLC · HWC Screw, Fixation, Bone
Cleared on Jun 9, 2023 as substantially equivalent to K202680 (Osteomed, LLC, 2020) and 3 other predicates after an 84-day review. Its family tree reaches back 7 generations to 1996. 1 later device descends from it.
- Decided
- Jun 9, 2023
- Review
- 84 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K962823 (1996). 35 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 6 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 5 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 4 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 3 generations backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- 2 generations backK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- 1 generation backK110658 Aptus Cannulated Compression ScrewsMedartis AG · 2011
- This deviceK230744 Acumed Acutrak 3 Headless Compression Screw SystemAcumed, LLC · 2023
- Descendant · cites it directly · 0 of its ownK250251 Eleganz Fusion Screw System (Fusion Screw System)Dev4 · 2025
Most influential descendants
Showing 1 of 1 · See all- K250251Eleganz Fusion Screw System (Fusion Screw System)Dev4 · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −6 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −5 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −4 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −3 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| −2 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| −1 | K110658 | Aptus Cannulated Compression Screws | Medartis AG | 2011 | — |
| 0 (this device) | K230744 | Acumed Acutrak 3 Headless Compression Screw System | Acumed, LLC | 2023 | — |
| +1 | K250251 | Eleganz Fusion Screw System (Fusion Screw System) | Dev4 | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K202680 | OsteoMed ExtremiFix Mini & Small Cannulated Screw SystemSummary page 4….3040 Product Code: HWC III. Legally Marketed Primary Predicate Devices Primary Predicate Device: OsteoMed ExtremiFix Mini & Small Cannulated Screws Screw System K202680 Common Name: Screw, Fixation, Bone Classification Name: Smooth or threaded metallic bone fixation fastener Regulation Number: 21… | 2020 |
| * | K163303 | OsteoMed ExtremiFix Mid and Large Screw SystemSummary page 4…Smooth or threaded metallic bone fixation fastener Regulation Number: 21 CFR 888.3040 Product Code: HWC Predicate Device: OsteoMed ExtremiFix Mid & Large Screw System, K163303 Common Name: Screw, Fixation, Bone Classification Name: Smooth or threaded metallic bone fixation fastener Regulation Number: 21… | 2017 |
| * | K063298 | Osteomed Headless Cannulated Screw SystemSummary page 4…Smooth or threaded metallic bone fixation fastener Regulation Number: 21 CFR 888.3040 Product Code: HWC Predicate Device: OsteoMed ExtremiFix Mid & Large Screw System, K063298 Common Name: Screw, Fixation, Bone Classification Name: Smooth or threaded metallic bone fixation fastener Regulation Number: 21… | 2007 |
| * | K110658 | Aptus Cannulated Compression ScrewsSummary page 4…aded metallic bone fixation fastener Regulation Number: 21 CFR 888.3040 Product Code: HWC Predicate Device: Medartis Aptus SpeedTip Cannulated Compression Screw System, K110658 Common Name: Screw, Fixation, Bone Classification Name: Smooth or threaded metallic bone fixation fastener Regulation Number: 21… | 2011 |
| † | K221333 | Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional | 2022 |
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 |
|---|---|---|---|
| K250251 | Eleganz Fusion Screw System (Fusion Screw System) | 2025 | 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 27 years and passes through 7 companies; a new generation was cleared every 3.0 years on median.
- 3 of the 35 ancestors have a recall of any class.
- Of its descendants, K250251 (Dev4, 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K202680.
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?
Acutrak 3 Headless Compression Screw System screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. The screws are not intended for interference or soft tissue fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230744 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230744: Acumed Acutrak 3 Headless Compression Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230744
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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