510(k) · Cleared
Recalled · Class II · 2022Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional
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 Dec 29, 2022 as substantially equivalent to K930834 (Acu Med, Inc., 1993) and 5 other predicates after a 234-day review. Its family tree reaches back 8 generations to 1996. It has been recalled 4 times.
- Decided
- Dec 29, 2022
- Review
- 234 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 4
- Predicates
- 6
Its longest line of descent runs back 8 generations to K962823 (1996). 72 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 8 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 7 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 6 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 5 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 4 generations backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- 3 generations backK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- 2 generations backK120493 Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 2012 · Recalled
- 1 generation backK123890 Acumed Cannulated Screw SystemAcumed, LLC · 2013 · Recalled
- This deviceK221333 Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR…Acumed, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −7 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −6 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −5 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −4 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| −3 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| −2 | K120493 | Mini Cannulated Headed and Headless Screw Set | Instratek, Inc. | 2012 | 1 |
| −1 | K123890 | Acumed Cannulated Screw System | Acumed, LLC | 2013 | 2 |
| 0 (this device) | K221333 | Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional | Acumed, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1981 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 10 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 7 | 0 |
| 2003 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 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? (6)
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 |
|---|---|---|---|
| * | K930834 | AcutractSummary page 4…llic bone fixation fastener Screw, Fixation, Bone 888.3040 HWC 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K930834 Acutrak Fixation System HWC K944330 Acutrak Plus Fixation System HWC K110658 APTUS Cannulated Compression Screws HWC K123890 Acum… | 1993 |
| * | K944330 | Acutrak Plus Fixation SystemSummary page 4…Fixation, Bone 888.3040 HWC 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K930834 Acutrak Fixation System HWC K944330 Acutrak Plus Fixation System HWC K110658 APTUS Cannulated Compression Screws HWC K123890 Acumed Cannulated Screw System HWC K1633… | 1995 |
| * | K110658 | Aptus Cannulated Compression ScrewsSummary page 4….92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K930834 Acutrak Fixation System HWC K944330 Acutrak Plus Fixation System HWC K110658 APTUS Cannulated Compression Screws HWC K123890 Acumed Cannulated Screw System HWC K163303 OsteoMed ExtremiFix Mid and Large Scre… | 2011 |
| * | K123890 | Acumed Cannulated Screw SystemSummary page 4…mary Predicate is listed first) Product Code K930834 Acutrak Fixation System HWC K944330 Acutrak Plus Fixation System HWC K110658 APTUS Cannulated Compression Screws HWC K123890 Acumed Cannulated Screw System HWC K163303 OsteoMed ExtremiFix Mid and Large Screw System HWC K202680 OsteoMed ExtremiFix Mini &… | 2013 |
| * | K163303 | OsteoMed ExtremiFix Mid and Large Screw SystemSummary page 4…e K930834 Acutrak Fixation System HWC K944330 Acutrak Plus Fixation System HWC K110658 APTUS Cannulated Compression Screws HWC K123890 Acumed Cannulated Screw System HWC K163303 OsteoMed ExtremiFix Mid and Large Screw System HWC K202680 OsteoMed ExtremiFix Mini & Small Cannulated Screw System HWC Device D… | 2017 |
| * | K202680 | OsteoMed ExtremiFix Mini & Small Cannulated Screw SystemSummary page 4…Fixation System HWC K110658 APTUS Cannulated Compression Screws HWC K123890 Acumed Cannulated Screw System HWC K163303 OsteoMed ExtremiFix Mid and Large Screw System HWC K202680 OsteoMed ExtremiFix Mini & Small Cannulated Screw System HWC Device Description Summary 21 CFR 807.92(a)(4) The purpose of thi… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 29, 2022 | Class II | Z-0767-2023 | No Marketing Application | Distribution without Pre-Market Clearance |
| Nov 29, 2022 | Class II | Z-0769-2023 | No Marketing Application | Distribution without Pre-Market Clearance |
| Nov 29, 2022 | Class II | Z-0768-2023 | No Marketing Application | Distribution without Pre-Market Clearance |
| Nov 29, 2022 | Class II | Z-0770-2023 | No Marketing Application | Distribution without Pre-Market Clearance |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 7 companies; a new generation was cleared every 3.0 years on median.
- 8 of the 72 ancestors have a recall of any class.
- 4 other devices also cite its predicate K930834.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Fusion, Standard and Mini, AcuTwist and Acutrak 2 Micro, Mini, Standard, 4.7, and 5.5 screws are Intended as a fixation device for small bones, bone fragments, and osteotomies. It is not intended for interference or soft tissue fixation. Acutrak Plus and (4/5), (6/7) and Acutrak 2 (7.5) and Dual-Trak screws are intended for fusions, fractures, or osteotomies of the clavicle, humerus, radius, ulna, ilium, femur, patella, fibula, tibia, talus…
Read the full statement (112 words)
Acutrak Fusion, Standard and Mini, AcuTwist and Acutrak 2 Micro, Mini, Standard, 4.7, and 5.5 screws are Intended as a fixation device for small bones, bone fragments, and osteotomies. It is not intended for interference or soft tissue fixation.
Acutrak Plus and (4/5), (6/7) and Acutrak 2 (7.5) and Dual-Trak screws are intended for fusions, fractures, or osteotomies of the clavicle, humerus, radius, ulna, ilium, femur, patella, fibula, tibia, talus, malleolus, and calcaneous.
The Acutrak Screw Systems are intended for use by surgeons with orthopedic training and knowledge of the indications and techniques required for fracture fixation. The device is to be implanted by the surgeon in a sterile operating room setting.
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/K221333 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221333: Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221333
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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