510(k) · Cleared
Recalled · 2009Arc Surgical Biotrak 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 Sep 19, 2006 as substantially equivalent to K032098 (Arthrex, Inc., 2003) and 2 other predicates after an 89-day review. Its family tree reaches back 1 generation to 1999. It has been recalled once.
- Decided
- Sep 19, 2006
- Review
- 89 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K992301 (1999). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK992301 Reunite ScrewsBiomet Manufacturing, Inc. · 1999
- This deviceK061763 Arc Surgical Biotrak ScrewArc Surgical, LLC · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992301 | Reunite Screws | Biomet Manufacturing, Inc. | 1999 | — |
| 0 (this device) | K061763 | Arc Surgical Biotrak Screw | Arc Surgical, LLC | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 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? (3)
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 |
|---|---|---|---|
| * | K032098 | Arthrex Bio-Compression Screw, Small, Arthrex Bio-Compression Screw, Large, Models…Summary page 1…Proposed Regulatory Class: Class II, 21 CFR 888.3040 Device Product Code: HWC Legally Marketed Equivalent Device(s): Arthrex Bio-Compression Screw K032098 Bionx Smart Screw K003077 Biomet ReUnite Bone Screw… | 2003 |
| * | K003077 | Smartscrew Model 222006...227510Summary page 1…ice Product Code: HWC Legally Marketed Equivalent Device(s): Arthrex Bio-Compression Screw K032098 Bionx Smart Screw K003077 Biomet ReUnite Bone Screw K992301 Device Description: The ARC Surgical Biotrak T M Screw… | 2001 |
| * | K992301 | Reunite ScrewsSummary page 1…: Arthrex Bio-Compression Screw K032098 Bionx Smart Screw K003077 Biomet ReUnite Bone Screw K992301 Device Description: The ARC Surgical Biotrak T M Screw System is composed of screws injection molded from poly-L-lactic acid (PL… | 1999 |
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 |
|---|---|---|---|---|
| Aug 21, 2009 | Not classified | Z-0073-2010 | Pending | Labeling may contain 2 lot numbers and 2 model numbers. It was observed that the box top label (30170060-S, W67391) does not match the two side labels (3010320-S, W67385). The part and patient labeling inside the box match the side labels… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K032098.
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 Biotrak TM resorbable compression screw is intended to provide fixation and/or reduction of small bone fractures, osteotomies, and arthrodeses, cancellous fragments, and osteochondral fragments in the upper and lower extremities. Specifically, these indications include osteochondral defects (OCDs), patella rim fractures, tarsal fractures, metatarsal fusions and fractures, metatarsal osteotomies, hallux valgus corrections, humeral condyle fractures, metacarpal fusions and fractures, carpal fusions and fractures, radial head fractures, and distal radius fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061763 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061763: Arc Surgical Biotrak Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061763
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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