510(k) · Cleared
ClearedLigafix Interference Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sciences For Bio Materials · HWC Screw, Fixation, Bone
Cleared on Jul 5, 2006 as substantially equivalent to K050407 (Sciences For Bio Materials, 2005) after a 61-day review. Its family tree reaches back 3 generations to 2000. 6 later devices descend from it.
- Decided
- Jul 5, 2006
- Review
- 61 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K994337 (2000). 4 ancestors in all, the oldest K002070 (2000). 6 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK994337 Vitoss Scaffold Synthetic Cancellous Bone Void FillerOrthovita Co. · 2000
- 2 generations backK021963 Biosorb Resorbable Void FillerSciences ET Bio Materiaux (Sbm) · 2003 · Recalled
- 1 generation backK050407 Ligafix Resorbable Interference Screw, Models 30 and 60Sciences For Bio Materials · 2005
- This deviceK061262 Ligafix Interference ScrewSciences For Bio Materials · 2006
- Descendant · cites it directly · 3 of its ownK070507 Modification to: Ligafix Interference ScrewScience For Biomaterials · 2007 · Recalled
- Descendant · cites it directly · 2 of its ownK090994 Ligafix Interface ScrewScience For Biomaterials · 2009
- Descendant · cites it directly · 1 of its ownK122228 Ligafix Interference ScrewSbm Sciences For Bio Materials · 2012
- Descendant · cites it directly · 1 of its ownK071437 Megafix-C Bioabsorbable Composite Interference Screw, Model…KARL STORZ Endoscopy-America, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK230394 Euroscrew NG; Euroscrew TCP NGTeknimed · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K070507Modification to: Ligafix Interference ScrewScience For Biomaterials · 2007 · cites it directly3descendants
- K090994Ligafix Interface ScrewScience For Biomaterials · 2009 · cites it directly2descendants
- K122228Ligafix Interference ScrewSbm Sciences For Bio Materials · 2012 · cites it directly1descendant
- K071437Megafix-C Bioabsorbable Composite Interference Screw, Model 2870719C, 2870723C…KARL STORZ Endoscopy-America, Inc. · 2007 · cites it directly1descendant
- K230394Euroscrew NG; Euroscrew TCP NGTeknimed · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K994337 | Vitoss Scaffold Synthetic Cancellous Bone Void Filler | Orthovita Co. | 2000 | — |
| −2 | K021963 | Biosorb Resorbable Void Filler | Sciences ET Bio Materiaux (Sbm) | 2003 | 1 |
| −1 | K050407 | Ligafix Resorbable Interference Screw, Models 30 and 60 | Sciences For Bio Materials | 2005 | — |
| 0 (this device) | K061262 | Ligafix Interference Screw | Sciences For Bio Materials | 2006 | — |
| +1 | K070507 | Modification to: Ligafix Interference Screw | Science For Biomaterials | 2007 | 1 |
| +1 | K090994 | Ligafix Interface Screw | Science For Biomaterials | 2009 | — |
| +1 | K122228 | Ligafix Interference Screw | Sbm Sciences For Bio Materials | 2012 | — |
| +1 | K071437 | Megafix-C Bioabsorbable Composite Interference Screw, Model 2870719C… | KARL STORZ Endoscopy-America, Inc. | 2007 | — |
| +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 |
|---|---|---|
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2022 | 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? (1)
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 1…II Product Code HWC CFR section 21CFR 888.3040 Device panel Orthopedic Legally marketed LIGAFIX" Resorbable Interference Screw K050407 predicate devices Reason for special 510k Extension of the range of products Submitter SCIENCE FOR BIOMATERIALS… | 2005 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K070507 (Science For Biomaterials, 2007) has gone furthest, with 3 descendants 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.
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?
LIGAFI e 30 is a cannulated, sterile, single-use, resorbable interference bone screw made of a mixture of tri calcium phosphate (30% 3-TCP) and Poly Lactic Acid (70% PLA) 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/K061262 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061262: Ligafix Interference Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061262
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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