510(k) · Cleared
ClearedLigafix Interface Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Science For Biomaterials · HWC Screw, Fixation, Bone
Cleared on May 6, 2009 as substantially equivalent to K050407 (Sciences For Bio Materials, 2005) and 2 other predicates after a 29-day review. Its family tree reaches back 5 generations to 2000. 2 later devices descend from it.
- Decided
- May 6, 2009
- Review
- 29 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K994337 (2000). 6 ancestors in all, the oldest K002070 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK994337 Vitoss Scaffold Synthetic Cancellous Bone Void FillerOrthovita Co. · 2000
- 4 generations backK021963 Biosorb Resorbable Void FillerSciences ET Bio Materiaux (Sbm) · 2003 · Recalled
- 3 generations backK050407 Ligafix Resorbable Interference Screw, Models 30 and 60Sciences For Bio Materials · 2005
- 2 generations backK061262 Ligafix Interference ScrewSciences For Bio Materials · 2006
- 1 generation backK070507 Modification to: Ligafix Interference ScrewScience For Biomaterials · 2007 · Recalled
- This deviceK090994 Ligafix Interface ScrewScience For Biomaterials · 2009
- Descendant · cites it directly · 1 of its ownK122228 Ligafix Interference ScrewSbm Sciences For Bio Materials · 2012
- Descendant · 2 generations on · 0 of its ownK230394 Euroscrew NG; Euroscrew TCP NGTeknimed · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K994337 | Vitoss Scaffold Synthetic Cancellous Bone Void Filler | Orthovita Co. | 2000 | — |
| −4 | K021963 | Biosorb Resorbable Void Filler | Sciences ET Bio Materiaux (Sbm) | 2003 | 1 |
| −3 | K050407 | Ligafix Resorbable Interference Screw, Models 30 and 60 | Sciences For Bio Materials | 2005 | — |
| −2 | K061262 | Ligafix Interference Screw | Sciences For Bio Materials | 2006 | — |
| −1 | K070507 | Modification to: Ligafix Interference Screw | Science For Biomaterials | 2007 | 1 |
| 0 (this device) | K090994 | Ligafix Interface Screw | Science For Biomaterials | 2009 | — |
| +1 | K122228 | Ligafix Interference Screw | Sbm Sciences For Bio Materials | 2012 | — |
| +2 | K230394 | Euroscrew NG; Euroscrew TCP NG | Teknimed | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K050407 | Ligafix Resorbable Interference Screw, Models 30 and 60Summary page 2…screws strength retention profiles are compatible with the healing process. 5. SUBSTANTIAL EQUIVALENCE The modifications to LIGAFIX® / ComposiTCP® Interference screw (K050407, K061262 and K070507) consist of additional size of screw together with the deletion of a reference to surgical technique in the… | 2005 |
| * | K061262 | Ligafix Interference ScrewSummary page 1…II Product Code HIWC CFR section 21CFR 888.3040 Device panel Orthopedic Legally marketed LIGAFIX® INTERFERENCE SCREW (K061262 and predicate devices K070507) manufactured by SCIENCE FOR BIOMATERIALS Submitt… | 2006 |
| * | K070507 | Modification to: Ligafix Interference ScrewSummary page 1…ction 21CFR 888.3040 Device panel Orthopedic Legally marketed LIGAFIX® INTERFERENCE SCREW (K061262 and predicate devices K070507) manufactured by SCIENCE FOR BIOMATERIALS Submitter SCIENCE FOR BIOMATERI… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122228 | Ligafix Interference Screw | 2012 | 1 |
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 4 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K122228 (Sbm Sciences For Bio Materials, 2012) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K050407.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
LIGAFIX® interference screws are designed for the interference fixation of
grafts in anterior cruciate ligament reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090994 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090994: Ligafix Interface Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090994
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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