510(k) · Cleared
ClearedBioscrew Absorbable Interference Srew
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linvatec Corp. · HWC Screw, Fixation, Bone
Cleared on Feb 27, 1998 after a 148-day review. The FDA summary names its predicate without a number. 416 later devices descend from it.
- Decided
- Feb 27, 1998
- Review
- 148 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
416 later devices descend from it, 10 citing it directly.
- This deviceK973758 Bioscrew Absorbable Interference SrewLinvatec Corp. · 1998
- Descendant · cites it directly · 310 of its ownK990194 BiobuttonLinvatec Corp. · 1999
- Descendant · 2 generations on · 309 of its ownK033717 Transet Fracture Fixation SystemBonutti Research, Inc. · 2004
- Descendant · 3 generations on · 306 of its ownK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- Descendant · 4 generations on · 217 of its ownK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- Descendant · 4 generations on · 94 of its ownK083070 Toggleloc SystemBiomet Sports Medicine · 2008 · Recalled
Showing 5 of 416 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 416 · See all- K990194BiobuttonLinvatec Corp. · 1999 · cites it directly310descendants
- K033717Transet Fracture Fixation SystemBonutti Research, Inc. · 2004 · 2 generations on309descendants
- K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc. · 2005 · 3 generations on306descendants
- K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc. · 2005 · 4 generations on217descendants
- K083070Toggleloc SystemBiomet Sports Medicine · 2008 · 4 generations on94descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973758 | Bioscrew Absorbable Interference Srew | Linvatec Corp. | 1998 | — |
| +1 | K990194 | Biobutton | Linvatec Corp. | 1999 | — |
| +2 | K033717 | Transet Fracture Fixation System | Bonutti Research, Inc. | 2004 | — |
| +3 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| +4 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| +4 | K083070 | Toggleloc System | Biomet Sports Medicine | 2008 | 6 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 7 | 0 |
| 2009 | 13 | 0 |
| 2010 | 5 | 0 |
| 2011 | 10 | 0 |
| 2012 | 8 | 0 |
| 2013 | 12 | 0 |
| 2014 | 21 | 0 |
| 2015 | 11 | 0 |
| 2016 | 8 | 0 |
| 2017 | 23 | 0 |
| 2018 | 19 | 0 |
| 2019 | 32 | 0 |
| 2020 | 27 | 0 |
| 2021 | 24 | 0 |
| 2022 | 28 | 0 |
| 2023 | 34 | 0 |
| 2024 | 37 | 0 |
| 2025 | 38 | 0 |
| 2026 | 36 | 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 |
|---|---|---|---|
| * | — | Linvatec BioScrew Absorbable Interference Screw Named without a submission number | |
| * | — | Arthrex Interference Screws Named without a submission number | |
| * | — | Arthrotek Interference Screw Named without a submission number |
What descends from it? (416)
See all 41610 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990194 | Biobutton | 1999 | 310 |
| K013131 | Bioscrew Xtralok | 2002 | 77 |
| K993073 | Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025… | 1999 | 16 |
| K032894 | Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T… | 2004 | 15 |
| K051611 | Mbaresorb Implant | 2005 | 10 |
| K063588 | Matryx Interference Screw, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5 | 2007 | 3 |
| K013781 | Rididfix 2.7MM BTB Cross Pin Kit | 2002 | 3 |
| K021280 | Inion Hexalon Biodegradable Acl/PCL Screw | 2002 | 1 |
| K993166 | Stryker Bioabsorbable Interference Screw System | 2000 | 1 |
| K031939 | Bio-Eurolig Interference Screw | 2004 | 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?
- Of its descendants, K990194 (Linvatec Corp., 1999) has gone furthest, with 310 descendants of its own.
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?
1. The BioScrew is used to provide interference fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament reconstruction.
2. The BioScrew is used to provide interference fixation during femoral and/or tibial fixation in anterior cruciate ligament reconstruction using a soft tissue graft (semitendinosus, gracilis).
3. The BioScrew is used to provide interference fixation during posterior cruciate ligament reconstruction.
Implantation of the interference screw is accomplished through arthroscopy or arthrotomy. This device is a single-use device.
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/K973758 · printed Nov 5, 2026
Cite this page
510(k) Report. “K973758: Bioscrew Absorbable Interference Srew.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973758
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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