510(k) · Cleared
ClearedArc Surgical Bone Reduction Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arc Surgical, LLC · HWC Screw, Fixation, Bone
Cleared on Dec 27, 2006 as substantially equivalent to K023294 (Howmedica Osteonics Corp., 2002) and 3 other predicates after a 62-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Dec 27, 2006
- Review
- 62 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K961498 (1997). 5 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK961498 Resch Arthroscopic and Percutaneous Screw Fixation System (a.S.F.)Howmedica, Inc. · 1997
- 1 generation backK013775 Twinfix Interfragmentary Compression Screw SystemStryker Leibinger · 2002
- This deviceK063244 Arc Surgical Bone Reduction ScrewArc Surgical, LLC · 2006
- Descendant · cites it directly · 0 of its ownK111608 Slic Screw Repair SystemAcumed, LLC · 2011
Most influential descendants
Showing 1 of 1 · See all- K111608Slic Screw Repair SystemAcumed, LLC · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961498 | Resch Arthroscopic and Percutaneous Screw Fixation System (a.S.F.) | Howmedica, Inc. | 1997 | — |
| −1 | K013775 | Twinfix Interfragmentary Compression Screw System | Stryker Leibinger | 2002 | — |
| 0 (this device) | K063244 | Arc Surgical Bone Reduction Screw | Arc Surgical, LLC | 2006 | — |
| +1 | K111608 | Slic Screw Repair System | Acumed, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K023294 | Bosworth Coraco-Clavicular ScrewSummary page 1…d Regulatory Class: Class II, 21 CFR 888.3040 Device Product Code: HWC Legally Marketed Equivalent Device(s): Howmedica Osteonics Bosworth CC Screw K023294 Zimmer Herbert Bone Screw K792022 Stryker Leibinger… | 2002 |
| * | K792022 | Herbert Bone ScrewSummary page 1…: HWC Legally Marketed Equivalent Device(s): Howmedica Osteonics Bosworth CC Screw K023294 Zimmer Herbert Bone Screw K792022 Stryker Leibinger TwinFix Screw K013775 Biomet SS C… | 1979 |
| * | K013775 | Twinfix Interfragmentary Compression Screw SystemSummary page 1…Bosworth CC Screw K023294 Zimmer Herbert Bone Screw K792022 Stryker Leibinger TwinFix Screw K013775 Biomet SS Cannulated Screw K984209 Device Description: The ARC Surgical Bone Reduction Sc… | 2002 |
| * | K984209 | Stainless Steel Taper Foreman Nail Cannulated Screw, Stainless Steel Cannulated Screw…Summary page 1…rbert Bone Screw K792022 Stryker Leibinger TwinFix Screw K013775 Biomet SS Cannulated Screw K984209 Device Description: The ARC Surgical Bone Reduction Screw is a headless, cannulated two- piece screw assembly. The two-piece des… | 1999 |
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 |
|---|---|---|---|
| K111608 | Slic Screw Repair System | 2011 | 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 9 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K111608 (Acumed, LLC, 2011) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K023294.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 bone reduction screw is intended to provide fixation and anatomically reduce two bones or bone portions. Specifically, these indications include scapholunate ligament repair, scapholunate reduction, lunotriquetral ligament repair, lunotriquetral reduction, and carpal instability.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063244 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063244: Arc Surgical Bone Reduction Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063244
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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