510(k) Report

510(k) · Cleared

Cleared

Acutrak Plus Fixation System

K944330510(k) TraditionalCleared May 5, 1995241-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

Acu Med, Inc. · HWC Screw, Fixation, Bone

Cleared on May 5, 1995 after a 241-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 172 later devices descend from it.

Decided
May 5, 1995
Review
241 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
0

172 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2023: 29 descendants cleared2005: 1 descendant cleared1998: 1 descendant cleared2017: 5 descendants cleared2004: 1 descendant cleared2022: 17 descendants cleared2014: 3 descendants cleared2008: 2 descendants cleared2016: 6 descendants cleared2026: 22 descendants cleared2021: 14 descendants cleared2013: 2 descendants cleared2015: 4 descendants cleared2011: 1 descendant cleared2012: 2 descendants cleared2019: 7 descendants cleared2018: 4 descendants cleared2020: 10 descendants cleared2024: 21 descendants cleared2025: 20 descendants cleared1995200020052010201520202025
  1. This deviceK944330 Acutrak Plus Fixation SystemAcu Med, Inc. · 1995
  2. Descendant · cites it directly · 145 of its ownK051309 Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005 · Recalled
  3. Descendant · 2 generations on · 144 of its ownK080398 SI Joint Fusion SystemSI-BONE, Inc. · 2008
  4. Descendant · 3 generations on · 143 of its ownK110838 Ifuse Implant SystemSI-BONE, Inc. · 2011
  5. Descendant · 3 generations on · 139 of its ownK122074 Ifuse Implant SystemSI-BONE, Inc. · 2012
  6. Descendant · 3 generations on · 134 of its ownK123850 Ifuse Implant SystemSI-BONE, Inc. · 2013

Showing 5 of 172 descendants. See all descendants

Descendants cleared per year

1998: 12004: 12005: 12008: 22011: 12012: 22013: 22014: 32015: 42016: 62017: 52018: 42019: 72020: 102021: 142022: 172023: 292024: 212025: 202026: 22
1998high 29 (2023) · low 0 (1999)2026

Most influential descendants

Showing 5 of 172 · See all
  • K051309Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005 · cites it directly145descendants
  • K080398SI Joint Fusion SystemSI-BONE, Inc. · 2008 · 2 generations on144descendants
  • K110838Ifuse Implant SystemSI-BONE, Inc. · 2011 · 3 generations on143descendants
  • K122074Ifuse Implant SystemSI-BONE, Inc. · 2012 · 3 generations on139descendants
  • K123850Ifuse Implant SystemSI-BONE, Inc. · 2013 · 3 generations on134descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K944330Acutrak Plus Fixation SystemAcu Med, Inc.1995—
+1K051309Roi Fusion Rods & PlatesReiley Orthopaedics, Inc.20052
+2K080398SI Joint Fusion SystemSI-BONE, Inc.2008—
+3K110838Ifuse Implant SystemSI-BONE, Inc.2011—
+3K122074Ifuse Implant SystemSI-BONE, Inc.2012—
+3K123850Ifuse Implant SystemSI-BONE, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200410
200510
200820
201110
201220
201320
201430
201540
201660
201750
201840
201970
2020100
2021140
2022170
2023290
2024210
2025200
2026220
FIG. 1 — Lineage of K944330, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (172)

See all 172

8 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K051309Roi Fusion Rods & PlatesReiley Orthopaedics, Inc.2005145
K131920Stabilization ScrewIn2bones Sas201418
K170038FuzeFix Screw SystemFusion Orthopedics, LLC20171
K170594I.B.S. osteosynthesis screwsIn2bones Sas20171
K040265Little Grafter ScrewBiocomposites, Ltd.20041
K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd.20230
K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLC20220
K972722Ultimate Compression Screw SystemOrthopedic Designs, Inc.19980

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?

  • Of its descendants, K051309 (Reiley Orthopaedics, Inc., 2005) has gone furthest, with 145 descendants of its own.

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—

More from Acu Med, Inc.

43 FDA decisions under this applicant name. See the company

  • K021321Wrist Fusion PlateAcu Med, Inc. · 2002
  • K013616Polarus Cap ScrewAcu Med, Inc. · 2001
  • K012655Congruent Bone Plate SystemAcu Med, Inc. · 200116 recalls
  • K992525Acumed Modular Shoulder SystemAcu Med, Inc. · 20001 recall
  • K993657Acumed Suture AnchorAcu Med, Inc. · 2000

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/K944330 · printed Nov 5, 2026

Cite this page

510(k) Report. “K944330: Acutrak Plus Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K944330

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026