510(k) · Cleared
ClearedBiosteon® Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biocomposites, Ltd. · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Feb 17, 2026 as substantially equivalent to K202535 (Arthrex, Inc., 2020) and 1 other predicate after a 263-day review. Its family tree reaches back 9 generations to 1997.
- Decided
- Feb 17, 2026
- Review
- 263 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K971358 (1997). 23 ancestors in all, the oldest K915424 (1993). No later device cites it as a predicate yet.
- Root · 9 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 5 generations between
- 3 generations backK071176 Modification to: Arthrex Interference ScrewArthrex, Inc. · 2007
- 2 generations backK180662 Arthrex FastThread Interference ScrewArthrex, Inc. · 2018
- 1 generation backK202535 Arthrex FastThread Interference ScrewArthrex, Inc. · 2020
- This deviceK251680 Biosteon® ScrewBiocomposites, Ltd. · 2026
Show all 9 generations
- Root · 9 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 8 generations backK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
- 7 generations backK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
- 6 generations backK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
- 5 generations backK032717 Biocryl Rapide Interference ScrewMitek Worldwide · 2004
- 4 generations backK060830 Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006
- 3 generations backK071176 Modification to: Arthrex Interference ScrewArthrex, Inc. · 2007
- 2 generations backK180662 Arthrex FastThread Interference ScrewArthrex, Inc. · 2018
- 1 generation backK202535 Arthrex FastThread Interference ScrewArthrex, Inc. · 2020
- This deviceK251680 Biosteon® ScrewBiocomposites, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K971358 | Bio-Interference Screw, 7 MM, 8 MM, 9 MM | Arthrex, Inc. | 1997 | — |
| −8 | K990454 | Bio-Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −7 | K993975 | Absolute Absorbable Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −6 | K013572 | Mitek Biocryl Interference Screws | Mitek Products | 2002 | — |
| −5 | K032717 | Biocryl Rapide Interference Screw | Mitek Worldwide | 2004 | — |
| −4 | K060830 | Milagro Interference Screw | Depuy Mitek, A Johnson & Johnson Company | 2006 | — |
| −3 | K071176 | Modification to: Arthrex Interference Screw | Arthrex, Inc. | 2007 | — |
| −2 | K180662 | Arthrex FastThread Interference Screw | Arthrex, Inc. | 2018 | — |
| −1 | K202535 | Arthrex FastThread Interference Screw | Arthrex, Inc. | 2020 | — |
| 0 (this device) | K251680 | Biosteon® Screw | Biocomposites, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 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 MAI? 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 MAI device
- #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 11 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 |
|---|---|---|---|
| * | K202535 | Arthrex FastThread Interference ScrewSummary page 5…ass II Product Code MAI, HWC Panel Orthopedic Predicates Primary Predicate Arthrex – FastThread Interference Screw (K202535) Secondary Predicate Biocomposites – Biosteon® Screw (K003641) Reference Devices Arthrex – SwiveLock Anchor… | 2020 |
| * | K003641 | Biolok Screw, Biosteon ScrewSummary page 5…Orthopedic Predicates Primary Predicate Arthrex – FastThread Interference Screw (K202535) Secondary Predicate Biocomposites – Biosteon® Screw (K003641) Reference Devices Arthrex – SwiveLock Anchor (K201749) Device Description The Biosteon® Screw is a cannulated, tape… | 2001 |
| † | K201749 | Arthrex SwiveLock Anchor | 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)
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 29 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 23 ancestors has a recall of any class.
- 1 other device also cites its predicate K202535.
How does its category compare?
All MAI devicesMAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MAI
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAI
54in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAI
40in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAI
2,148in 2025
MAUDE reports naming product code MAI, 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 | 4 | 100 | 0 | 272 |
| 2008 | 3 | 83 | 0 | 172 |
| 2009 | 9 | 74 | 0 | 88 |
| 2010 | 4 | 122 | 0 | 89 |
| 2011 | 9 | 90 | 5 | 129 |
| 2012 | 6 | 56 | 10 | 171 |
| 2013 | 6 | 135 | 0 | 166 |
| 2014 | 4 | 86 | 0 | 149 |
| 2015 | 5 | 95 | 0 | 182 |
| 2016 | 3 | 191 | 0 | 301 |
| 2017 | 9 | 113 | 0 | 478 |
| 2018 | 13 | 108 | 0 | 1,590 |
| 2019 | 9 | 41 | 2 | 1,248 |
| 2020 | 9 | 78 | 40 | 957 |
| 2021 | 8 | 115 | 0 | 1,267 |
| 2022 | 6 | 136 | 0 | 1,425 |
| 2023 | 8 | 34 | 0 | 1,718 |
| 2024 | 7 | 53 | 0 | 2,300 |
| 2025 | 8 | 54 | 0 | 2,148 |
| 2026 | 5 | 69 | 1 | — |
What is it indicated for?
The Biosteon TM Screw is indicated for use in anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), medial collateral ligament (MCL), lateral collateral ligament (LCL), and medial patellofemoral ligament (MPFL) reconstruction procedures where the surgeon: • places the graft in tibial and/or femoral tunnels; and • inserts between the tunnel wall and graft to hold the graft in place The Biosteon TM Screw is used to provide interference…
Read the full statement (112 words)
The Biosteon TM Screw is indicated for use in anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), medial collateral ligament (MCL), lateral collateral ligament (LCL), and medial patellofemoral ligament (MPFL) reconstruction procedures where the surgeon:
• places the graft in tibial and/or femoral tunnels; and
• inserts between the tunnel wall and graft to hold the graft in place
The Biosteon TM Screw is used to provide interference fixation of patellar bone-tendon-bone grafts in ACL, PCL, MCL, LCL, and MPFL reconstruction.
The Bioston TM Screw is used to provide interference fixation during femoral and/or patellar tibial fixation in ACL, PCL, MCL, LCL, and MPFL reconstruction using a soft tissue graft (semi-tendonodesis gracilis).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251680 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251680: Biosteon® Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251680
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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