510(k) Report

510(k) · Cleared

Cleared

Infix Cannulated Screw System

K142057510(k) TraditionalCleared Jan 13, 2015168-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

Infix Medical, LLC · HWC Screw, Fixation, Bone

Cleared on Jan 13, 2015 as substantially equivalent to K962011 (Synthes (Usa), 1996) and 6 other predicates after a 168-day review. Its family tree reaches back 8 generations to 2000. 1 later device descends from it.

Decided
Jan 13, 2015
Review
168 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
7

Its longest line of descent runs back 8 generations to K000684 (2000). 71 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 7 other ancestors2001: 4 other ancestors1996: 8 other ancestors2010: 2 other ancestors2009: 1 other ancestor2008: 2 other ancestors2007: 2 other ancestors2006: 5 other ancestors2005: 5 other ancestors1997: 1 other ancestor2003: 2 other ancestors2000: 2 other ancestors1999: 4 other ancestors1979: 1 other ancestor1995: 3 other ancestors1994: 2 other ancestors1993: 1 other ancestor1992: 4 other ancestors1990: 1 other ancestor1980: 1 other ancestor1991: 1 other ancestor1989: 3 other ancestors1981: 1 other ancestor2017: 1 descendant clearedK000684 · Small Fragment Dynamic Compression Locking (DCL) System · Synthes (Usa) · 2000 · recalled×2: 2 generations cleared close together, K011335 (2001), K012655 (2001) K021626 · Hallu Plates · New Deal, S.A. · 2002K040907 · Arthrex Small Fragment Plates and Screws · Arthrex, Inc. · 2004K052614 · Low Profile Plate and Screw System · Arthrex, Inc. · 2005K103705 · Low Profile Screws · Arthrex, Inc. · 2011K111678 · Ortho Solutions Extremity Fixation Implants for Osteosysnthesis · Ortho Solutions Limited · 2012 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 16 other ancestors3 generations back: 13 other ancestors4 generations back: 15 other ancestors5 generations back: 13 other ancestors 1 generation forward: 1 descendant K111678 · Ortho Solutions Extremity Fixation Implants for Osteosysnthesis · Ortho Solutions Limited · 2012 · recalledK103705 · Low Profile Screws · Arthrex, Inc. · 2011K052614 · Low Profile Plate and Screw System · Arthrex, Inc. · 2005K040907 · Arthrex Small Fragment Plates and Screws · Arthrex, Inc. · 2004K021626 · Hallu Plates · New Deal, S.A. · 2002K012655 · Congruent Bone Plate System · Acu Med, Inc. · 2001 · recalledK011335 · Synths One-Third Tubular DCL Plate · Synthes (Usa) · 2001 · recalledK000684 · Small Fragment Dynamic Compression Locking (DCL) System · Synthes (Usa) · 2000 · recalled−50
  1. Root · 8 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
  2. 7 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
  3. 6 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
  4. 5 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
  5. 4 generations backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
  6. 3 generations backK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
  7. 2 generations backK103705 Low Profile ScrewsArthrex, Inc. · 2011
  8. 1 generation backK111678 Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · Recalled
  9. This deviceK142057 Infix Cannulated Screw SystemInfix Medical, LLC · 2015
  10. Descendant · cites it directly · 0 of its ownK162874 Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A · 2017

Most influential descendants

Showing 1 of 1 · See all
  • K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A · 2017 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K000684Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa)20001
−7K011335Synths One-Third Tubular DCL PlateSynthes (Usa)20012
−6K012655Congruent Bone Plate SystemAcu Med, Inc.200116
−5K021626Hallu PlatesNew Deal, S.A.2002—
−4K040907Arthrex Small Fragment Plates and ScrewsArthrex, Inc.2004—
−3K052614Low Profile Plate and Screw SystemArthrex, Inc.2005—
−2K103705Low Profile ScrewsArthrex, Inc.2011—
−1K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited20121
0 (this device)K142057Infix Cannulated Screw SystemInfix Medical, LLC2015—
+1K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198010
198110
198930
199010
199110
199240
199310
199420
199530
199680
199710
199940
200020
200140
200270
200320
200550
200650
200720
200820
200910
201020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
FIG. 1 — Lineage of K142057, 2000–2017Source: 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? (7)

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
*K962011Synthes 7.0/7.3 MM Cannulated Screws
Summary page 4
…888.3040 Smooth or threaded metallic bone fixation fastener Product Code: HWC Predicate Device Information: SYNTHES 7.0/7.3 MM CANNULATED SCREWS (K962011) SYNTHES 6.5 MM CANNULATED SCREWS (K021932) SYNTHES STERILE 4.5 MM CANNULATED SCREWS (K963172) SYNTHES STERILE 3.5 MM AND 4.0 MM…
Synthes (Usa)1996—
*K021932Synthes 6.5 MM Cannulated Screw
Summary page 4
…aded metallic bone fixation fastener Product Code: HWC Predicate Device Information: SYNTHES 7.0/7.3 MM CANNULATED SCREWS (K962011) SYNTHES 6.5 MM CANNULATED SCREWS (K021932) SYNTHES STERILE 4.5 MM CANNULATED SCREWS (K963172) SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS (K963192) SYNTHES STERILE…
Synthes (Usa)20027
*K963172Synthes Sterile 4.5 MM Cannulated Screws
Summary page 4
…: HWC Predicate Device Information: SYNTHES 7.0/7.3 MM CANNULATED SCREWS (K962011) SYNTHES 6.5 MM CANNULATED SCREWS (K021932) SYNTHES STERILE 4.5 MM CANNULATED SCREWS (K963172) SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS (K963192) SYNTHES STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHER (K9628…
Synthes (Usa)1996—
*K963192Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws
Summary page 4
…LATED SCREWS (K962011) SYNTHES 6.5 MM CANNULATED SCREWS (K021932) SYNTHES STERILE 4.5 MM CANNULATED SCREWS (K963172) SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS (K963192) SYNTHES STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHER (K962823) SYNTHES 2.4 MM CANNULATED SCREW (K012945) ORTHO SOLUTIONS…
Synthes (Usa)1996—
*K962823Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer
Summary page 4
…HES STERILE 4.5 MM CANNULATED SCREWS (K963172) SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS (K963192) SYNTHES STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHER (K962823) SYNTHES 2.4 MM CANNULATED SCREW (K012945) ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS (K111678) Device Des…
Synthes (Usa)1996—
*K012945Synthes 2.4 MM Cannulated Screw
Summary page 4
…172) SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS (K963192) SYNTHES STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHER (K962823) SYNTHES 2.4 MM CANNULATED SCREW (K012945) ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS (K111678) Device Description: The InFix Cannulated Screw Syste…
Synthes (Usa)20011
*K111678Ortho Solutions Extremity Fixation Implants for Osteosysnthesis
Summary page 4
…STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHER (K962823) SYNTHES 2.4 MM CANNULATED SCREW (K012945) ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS (K111678) Device Description: The InFix Cannulated Screw System includes eight cannulated screw specifications and associated washers, w…
Ortho Solutions Limited20121

Also cleared against K962011: 26 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
K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170

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 15 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
  • 13 of the 71 ancestors have a recall of any class.
  • Of its descendants, K162874 (Neoortho Produtos Ortopedicos S/A, 2017) has gone furthest, with 0 descendants of its own.
  • 26 other devices also cite its predicate K962011.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

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?

InFix Cannulated Screw System is generally intended for fracture fixation of various bones and bone fragments, such as femoral neck, intercondylar femoral, malleolus, pilon tibial, calcaneus, talus, tibial plateau, tarsal, metatarsal, wrist, metacarpal, carpal, scaphoid and radius fracture.

InFix Cannulated Screw System is also intended for fixation arthrodesis, iliosacral dislocations, and hallux valgus corrections.

Accessories implants:

The round washer is used to increase bone contact area for distributing the forces/load and prevent the screw head from sinking into the bone.

Indications for use as stated in the FDA summary.

Also cleared against K962011

26 other devices cite the same predicate.

  • K222282HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company · 2022
  • K183119SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® InstrumentsGlobus Medical, Inc. · 2019
  • K173201UNITY Sacroiliac Joint Fixation SystemHuvexel Co., Ltd. · 2018
  • K171595M.U.S.T. Sacral Iliac Screw and Pelvic Trauma SystemMedacta International S.A. · 2017
  • K170021SMV Scientific Cannulated ScrewsSmv Scientific · 2017
  • K161894SurgTech Trauma SystemSurgtech, Inc. · 2017

Recent decisions in HWC

The HWC category page

  • K261961Ntegrate Threaded Nail SystemNvision Biomedical Technologies · 2026
  • 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/K142057 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142057: Infix Cannulated Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142057

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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