510(k) Report

510(k) · Cleared

Cleared

Ligafix Interference Screw

K122228510(k) SpecialCleared Oct 3, 201269-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sbm Sciences For Bio Materials · MAI Fastener, Fixation, Biodegradable, Soft Tissue

Cleared on Oct 3, 2012 as substantially equivalent to K050407 (Sciences For Bio Materials, 2005) and 3 other predicates after a 69-day review. Its family tree reaches back 6 generations to 2000. 1 later device descends from it.

Decided
Oct 3, 2012
Review
69 days
Class
Class II
Product code
MAI
Recalls
None
Predicates
4

Its longest line of descent runs back 6 generations to K994337 (2000). 7 ancestors in all, the oldest K002070 (2000). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor2023: 1 descendant clearedK994337 · Vitoss Scaffold Synthetic Cancellous Bone Void Filler · Orthovita Co. · 2000K021963 · Biosorb Resorbable Void Filler · Sciences ET Bio Materiaux (Sbm) · 2003 · recalledK050407 · Ligafix Resorbable Interference Screw, Models 30 and 60 · Sciences For Bio Materials · 2005K061262 · Ligafix Interference Screw · Sciences For Bio Materials · 2006K070507 · Modification to: Ligafix Interference Screw · Science For Biomaterials · 2007 · recalledK090994 · Ligafix Interface Screw · Science For Biomaterials · 2009200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 1 descendant K090994 · Ligafix Interface Screw · Science For Biomaterials · 2009K070507 · Modification to: Ligafix Interference Screw · Science For Biomaterials · 2007 · recalledK061262 · Ligafix Interference Screw · Sciences For Bio Materials · 2006K050407 · Ligafix Resorbable Interference Screw, Models 30 and 60 · Sciences For Bio Materials · 2005K021963 · Biosorb Resorbable Void Filler · Sciences ET Bio Materiaux (Sbm) · 2003 · recalledK994337 · Vitoss Scaffold Synthetic Cancellous Bone Void Filler · Orthovita Co. · 2000−50
  1. Root · 6 generations backK994337 Vitoss Scaffold Synthetic Cancellous Bone Void FillerOrthovita Co. · 2000
  2. 5 generations backK021963 Biosorb Resorbable Void FillerSciences ET Bio Materiaux (Sbm) · 2003 · Recalled
  3. 4 generations backK050407 Ligafix Resorbable Interference Screw, Models 30 and 60Sciences For Bio Materials · 2005
  4. 3 generations backK061262 Ligafix Interference ScrewSciences For Bio Materials · 2006
  5. 2 generations backK070507 Modification to: Ligafix Interference ScrewScience For Biomaterials · 2007 · Recalled
  6. 1 generation backK090994 Ligafix Interface ScrewScience For Biomaterials · 2009
  7. This deviceK122228 Ligafix Interference ScrewSbm Sciences For Bio Materials · 2012
  8. Descendant · cites it directly · 0 of its ownK230394 Euroscrew NG; Euroscrew TCP NGTeknimed · 2023

Most influential descendants

Showing 1 of 1 · See all
  • K230394Euroscrew NG; Euroscrew TCP NGTeknimed · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K994337Vitoss Scaffold Synthetic Cancellous Bone Void FillerOrthovita Co.2000—
−5K021963Biosorb Resorbable Void FillerSciences ET Bio Materiaux (Sbm)20031
−4K050407Ligafix Resorbable Interference Screw, Models 30 and 60Sciences For Bio Materials2005—
−3K061262Ligafix Interference ScrewSciences For Bio Materials2006—
−2K070507Modification to: Ligafix Interference ScrewScience For Biomaterials20071
−1K090994Ligafix Interface ScrewScience For Biomaterials2009—
0 (this device)K122228Ligafix Interference ScrewSbm Sciences For Bio Materials2012—
+1K230394Euroscrew NG; Euroscrew TCP NGTeknimed2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
FIG. 1 — Lineage of K122228, 2000–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
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What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K050407Ligafix Resorbable Interference Screw, Models 30 and 60
Summary page 1
…I Product Codes MAI Device panel ORTHOPEDIC Legally marketed LIGAFIX INTERFERENCE SCREW (K050407, K061262, K070507 and predicate devices K090994) manufactured by SCIENCE FOR BIOMATERIALS Description: LIGAFIX'…
Sciences For Bio Materials2005—
*K061262Ligafix Interference Screw
Summary page 1
…I Product Codes MAI Device panel ORTHOPEDIC Legally marketed LIGAFIX INTERFERENCE SCREW (K050407, K061262, K070507 and predicate devices K090994) manufactured by SCIENCE FOR BIOMATERIALS Description: LIGAFIX' / Composi…
Sciences For Bio Materials2006—
*K070507Modification to: Ligafix Interference Screw
Summary page 1
…I Product Codes MAI Device panel ORTHOPEDIC Legally marketed LIGAFIX INTERFERENCE SCREW (K050407, K061262, K070507 and predicate devices K090994) manufactured by SCIENCE FOR BIOMATERIALS Description: LIGAFIX' / ComposiTCP' rang…
Science For Biomaterials20071
*K090994Ligafix Interface Screw
Summary page 1
…Device panel ORTHOPEDIC Legally marketed LIGAFIX INTERFERENCE SCREW (K050407, K061262, K070507 and predicate devices K090994) manufactured by SCIENCE FOR BIOMATERIALS Description: LIGAFIX' / ComposiTCP' range of products consists of resorbable cannulat…
Science For Biomaterials2009—

Also cleared against K050407: 4 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K230394Euroscrew NG; Euroscrew TCP NGTeknimed20230

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 12 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
  • 2 of the 7 ancestors have a recall of any class.
  • Of its descendants, K230394 (Teknimed, 2023) has gone furthest, with 0 descendants of its own.
  • 4 other devices also cite its predicate K050407.

How does its category compare?

All MAI devices

MAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · MAI

8in 2025

2007: 42008: 32009: 92010: 42011: 92012: 62013: 62014: 42015: 52016: 32017: 92018: 132019: 92020: 92021: 82022: 62023: 82024: 72025: 82026 (partial year): 5
2007high 13 (2018) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAI

54in 2025

2007: 100 days median2008: 83 days median2009: 74 days median2010: 122 days median2011: 90 days median2012: 56 days median2013: 135 days median2014: 86 days median2015: 95 days median2016: 191 days median2017: 113 days median2018: 108 days median2019: 41 days median2020: 78 days median2021: 115 days median2022: 136 days median2023: 34 days median2024: 53 days median2025: 54 days median2026 (partial year): 69 days median
2007high 191 (2016) · low 34 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MAI

40in 2020

2011: 52012: 102019: 22020: 402026 (partial year): 1
2007high 40 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MAI

2,148in 2025

2007: 2722008: 1722009: 882010: 892011: 1292012: 1712013: 1662014: 1492015: 1822016: 3012017: 4782018: 1,5902019: 1,2482020: 9572021: 1,2672022: 1,4252023: 1,7182024: 2,3002025: 2,148
2007high 2,300 (2024) · low 88 (2009)2025

MAUDE reports naming product code MAI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200741000272
20083830172
2009974088
20104122089
20119905129
201265610171
201361350166
20144860149
20155950182
201631910301
201791130478
20181310801,590
201994121,248
202097840957
2021811501,267
2022613601,425
202383401,718
202475302,300
202585402,148
20265691—

What is it indicated for?

LIGAFIX® / ComposiTCP® is a cannulated, sterile, single-use, resorbable interference bone screw made of a mixture of tri calcium phosphate (beta-TCP) and Poly Lactic Acid (PLA) designed for the interference fixation of grafts in anterior cruciate ligament reconstruction.

Indications for use as stated in the FDA summary.

Also cleared against K050407

4 other devices cite the same predicate.

  • K090994Ligafix Interface ScrewScience For Biomaterials · 2009
  • K071437Megafix-C Bioabsorbable Composite Interference Screw, Model 2870719C, 2870723C, 2870823C, 2870828C, 2870928CKARL STORZ Endoscopy-America, Inc. · 2007
  • K070507Modification to: Ligafix Interference ScrewScience For Biomaterials · 20071 recall
  • K061262Ligafix Interference ScrewSciences For Bio Materials · 2006

More from Sbm Sciences For Bio Materials

3 FDA decisions under this applicant name. See the company

  • K151004PULLUP® Adjustable Juxtacortical Fixation DeviceSbm Sciences For Bio Materials · 2015
  • K130953Neotis; Neotis 50Sbm Sciences For Bio Materials · 2013

Recent decisions in MAI

The MAI category page

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  • K253931Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K260294SF Push-in AnchorSurgical Fusion Technologies GmbH · 2026
  • K254055OSSIOfiber® Suture AnchorOSSIO, Ltd. · 2026
  • K251680Biosteon® ScrewBiocomposites, Ltd. · 2026

https://510kreport.com/device/K122228 · printed Nov 5, 2026

Cite this page

510(k) Report. “K122228: Ligafix Interference Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122228

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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