510(k) Report

510(k) · Cleared

Cleared

Triabsorb Composite Screw

K050468510(k) TraditionalCleared Aug 31, 2005189-day reviewClass II21 CFR 888.3040

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

Advanced Biomaterials · HWC Screw, Fixation, Bone

Cleared on Aug 31, 2005 as substantially equivalent to K013572 (Mitek Products, 2002) and 3 other predicates after a 189-day review. Its family tree reaches back 7 generations to 1994.

Decided
Aug 31, 2005
Review
189 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
4

Its longest line of descent runs back 7 generations to K933738 (1994). 34 ancestors in all, the oldest K895711 (1990). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestor2001: 3 other ancestors2000: 2 other ancestors1999: 4 other ancestors1998: 4 other ancestors1995: 4 other ancestors1994: 2 other ancestors1997: 1 other ancestor1996: 5 other ancestors1990: 1 other ancestorK933738 · M. Kurosaka Interference Fixation Screw · Depuy, Inc. · 1994 · recalledK955733 · Hyloc Interference Screw (Cannulated)/(Non-Cannulated) · Depuy, Inc. · 1996K980440 · Depuy Orthotech Phantom Sof-Thread Soft Tissue Interference Screw · Depuy, Inc. · 1998K981670 · Depuy Profile Round Head Interference Screw and Depuy Phantom Resorbable Interference Screw · Depuy, Inc. · 1998K982662 · Depuy Profile Round Head Interference Screw, Depuy Phantom Resorbable Interference Screw · DePuy Orthopaedics, Inc. · 1998 · recalledK993073 · Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030 · Bionx Implants, Ltd. · 1999K032894 · Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T, · Linvatec Biomaterials, Inc. · 20041990199520002005
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 7 other ancestors3 generations back: 11 other ancestors4 generations back: 6 other ancestors K032894 · Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T, · Linvatec Biomaterials, Inc. · 2004K993073 · Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030 · Bionx Implants, Ltd. · 1999K982662 · Depuy Profile Round Head Interference Screw, Depuy Phantom Resorbable Interference Screw · DePuy Orthopaedics, Inc. · 1998 · recalledK981670 · Depuy Profile Round Head Interference Screw and Depuy Phantom Resorbable Interference Screw · Depuy, Inc. · 1998K980440 · Depuy Orthotech Phantom Sof-Thread Soft Tissue Interference Screw · Depuy, Inc. · 1998K955733 · Hyloc Interference Screw (Cannulated)/(Non-Cannulated) · Depuy, Inc. · 1996K933738 · M. Kurosaka Interference Fixation Screw · Depuy, Inc. · 1994 · recalled−50
  1. Root · 7 generations backK933738 M. Kurosaka Interference Fixation ScrewDepuy, Inc. · 1994 · Recalled
  2. 6 generations backK955733 Hyloc Interference Screw (Cannulated)/(Non-Cannulated)Depuy, Inc. · 1996
  3. 5 generations backK980440 Depuy Orthotech Phantom Sof-Thread Soft Tissue Interference ScrewDepuy, Inc. · 1998
  4. 4 generations backK981670 Depuy Profile Round Head Interference Screw and Depuy Phantom…Depuy, Inc. · 1998
  5. 3 generations backK982662 Depuy Profile Round Head Interference Screw, Depuy Phantom…DePuy Orthopaedics, Inc. · 1998 · Recalled
  6. 2 generations backK993073 Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025…Bionx Implants, Ltd. · 1999
  7. 1 generation backK032894 Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T…Linvatec Biomaterials, Inc. · 2004
  8. This deviceK050468 Triabsorb Composite ScrewAdvanced Biomaterials · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K933738M. Kurosaka Interference Fixation ScrewDepuy, Inc.19942
−6K955733Hyloc Interference Screw (Cannulated)/(Non-Cannulated)Depuy, Inc.1996—
−5K980440Depuy Orthotech Phantom Sof-Thread Soft Tissue Interference ScrewDepuy, Inc.1998—
−4K981670Depuy Profile Round Head Interference Screw and Depuy Phantom Resorbable…Depuy, Inc.1998—
−3K982662Depuy Profile Round Head Interference Screw, Depuy Phantom Resorbable…DePuy Orthopaedics, Inc.19984
−2K993073Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020…Bionx Implants, Ltd.1999—
−1K032894Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T…Linvatec Biomaterials, Inc.2004—
0 (this device)K050468Triabsorb Composite ScrewAdvanced Biomaterials2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199420
199540
199650
199710
199840
199940
200020
200130
200210
FIG. 1 — Lineage of K050468, 1994–2005Source: 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 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. #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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
*K013572Mitek Biocryl Interference Screws
Summary page 1
…sual name: Composite Interference Screw Classification: Smooth or threaded bone fixation fastener: 888.3040 Predicate device: K013572 MITEK BIOCRYL INTERFERENCE SCREWS (MITEK) K032894 OSTEO ACL SCREW MODEL (LINVATEC) K002070 BIOLOK SCREW…
Mitek Products2002—
*K032894Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T…
Summary page 1
…lassification: Smooth or threaded bone fixation fastener: 888.3040 Predicate device: K013572 MITEK BIOCRYL INTERFERENCE SCREWS (MITEK) K032894 OSTEO ACL SCREW MODEL (LINVATEC) K002070 BIOLOK SCREW (BIOCOMPOSITES) K003641 BIOLOK SCREW, BIOSTEON SC…
Linvatec Biomaterials, Inc.2004—
*K002070Biolok Screw
Summary page 1
…bone fixation fastener: 888.3040 Predicate device: K013572 MITEK BIOCRYL INTERFERENCE SCREWS (MITEK) K032894 OSTEO ACL SCREW MODEL (LINVATEC) K002070 BIOLOK SCREW (BIOCOMPOSITES) K003641 BIOLOK SCREW, BIOSTEON SCREW (BIOCOMPOSITES) Device description:…
Biocomposites, Ltd.2000—
*K003641Biolok Screw, Biosteon Screw
Summary page 1
…evice: K013572 MITEK BIOCRYL INTERFERENCE SCREWS (MITEK) K032894 OSTEO ACL SCREW MODEL (LINVATEC) K002070 BIOLOK SCREW (BIOCOMPOSITES) K003641 BIOLOK SCREW, BIOSTEON SCREW (BIOCOMPOSITES) Device description: The TriABSorbTM composite screw is bio-ab…
Biocomposites, Ltd.2001—

Also cleared against K013572: 5 other devices →

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 11 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
  • 3 of the 34 ancestors have a recall of any class.
  • 5 other devices also cite its predicate K013572.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

To provide interference fixation of soft tissue graft and bone-tendon-bone patellar graft during the Anterior Cruciate Ligament repair through arthroscopy or arthrotomy.

Indications for use as stated in the FDA summary.

Also cleared against K013572

5 other devices cite the same predicate.

  • K091041Rigidfix Biocryl 2.7MM BTB (210815), Femoral 3.3MM ST (210816), and Tibial 3.3MM ST (210817) Cross Pin KitsDepuy Mitek, A Johnson & Johnson Company · 2009
  • K090669Rigidfix Biocryl Cross Pin KitsDepuy Mitek, A Johnson & Johnson Company · 2009
  • K081390Bioactif Osteotrans Interfence ScrewTakiron Co., Ltd. · 2008
  • K032717Biocryl Rapide Interference ScrewMitek Worldwide · 2004
  • K032167Bio-Intrafix Tibial Screw and SheathMitek Worldwide · 2003

More from Advanced Biomaterials

3 FDA decisions under this applicant name. See the company

  • K032830Plla Cannulated Interference ScrewAdvanced Biomaterials · 2004
  • K033749Titanium Cannulated Interference ScrewAdvanced Biomaterials · 2004

Recent decisions in HWC

The HWC category page

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  • K263116OsteoCentric Technologies Cannulated and Soild Fasteners with NutsOsteoCentric Technologies · 2026
  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K050468 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050468: Triabsorb Composite Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050468

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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