510(k) Report

510(k) · Cleared

Recalled · 2011

Roi Fusion Rods & Plates

K051309510(k) TraditionalCleared Jul 11, 200553-day reviewClass II21 CFR 888.3040Recalls 2

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

Reiley Orthopaedics, Inc. · HWC Screw, Fixation, Bone

Cleared on Jul 11, 2005 as substantially equivalent to K010783 (Osteomed Corp., 2001) and 2 other predicates after a 53-day review. Its family tree reaches back 1 generation to 1993. 145 later devices descend from it. It has been recalled 2 times.

Decided
Jul 11, 2005
Review
53 days
Class
Class II
Product code
HWC
Recalls
2
Predicates
3

Its longest line of descent runs back 1 generation to K930834 (1993). 3 ancestors in all. 145 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1995: 1 other ancestor2008: 1 descendant cleared2013: 2 descendants cleared2015: 4 descendants cleared2011: 1 descendant cleared2012: 2 descendants cleared2016: 5 descendants cleared2014: 2 descendants cleared2019: 5 descendants cleared2018: 3 descendants cleared2024: 21 descendants cleared2021: 11 descendants cleared2020: 7 descendants cleared2017: 2 descendants cleared2025: 19 descendants cleared2023: 26 descendants cleared2026: 18 descendants cleared2022: 16 descendants clearedK930834 · Acutract · Acu Med, Inc. · 19931990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 11 descendants3 generations forward: 18 descendants4 generations forward: 56 descendants5 generations forward: 28 descendants6 generations forward: 15 descendants7 generations forward: 7 descendants8 generations forward: 6 descendants9 generations forward: 2 descendants10 generations forward: 1 descendant K930834 · Acutract · Acu Med, Inc. · 19930+5+10
  1. Root · 1 generation backK930834 AcutractAcu Med, Inc. · 1993
  2. This deviceK051309 Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 2005
  3. Descendant · cites it directly · 144 of its ownK080398 SI Joint Fusion SystemSI-BONE, Inc. · 2008
  4. Descendant · 2 generations on · 143 of its ownK110838 Ifuse Implant SystemSI-BONE, Inc. · 2011
  5. Descendant · 2 generations on · 139 of its ownK122074 Ifuse Implant SystemSI-BONE, Inc. · 2012
  6. Descendant · 2 generations on · 134 of its ownK123850 Ifuse Implant SystemSI-BONE, Inc. · 2013
  7. Descendant · 2 generations on · 133 of its ownK131405 Ifuse Implant SystemSI-BONE, Inc. · 2013

Showing 5 of 145 descendants. See all descendants

Descendants cleared per year

2008: 12011: 12012: 22013: 22014: 22015: 42016: 52017: 22018: 32019: 52020: 72021: 112022: 162023: 262024: 212025: 192026: 18
2008high 26 (2023) · low 0 (2009)2026

Most influential descendants

Showing 5 of 145 · See all
  • K080398SI Joint Fusion SystemSI-BONE, Inc. · 2008 · cites it directly144descendants
  • K110838Ifuse Implant SystemSI-BONE, Inc. · 2011 · 2 generations on143descendants
  • K122074Ifuse Implant SystemSI-BONE, Inc. · 2012 · 2 generations on139descendants
  • K123850Ifuse Implant SystemSI-BONE, Inc. · 2013 · 2 generations on134descendants
  • K131405Ifuse Implant SystemSI-BONE, Inc. · 2013 · 2 generations on133descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K930834AcutractAcu Med, Inc.1993—
0 (this device)K051309Roi Fusion Rods & PlatesReiley Orthopaedics, Inc.2005—
+1K080398SI Joint Fusion SystemSI-BONE, Inc.2008—
+2K110838Ifuse Implant SystemSI-BONE, Inc.2011—
+2K122074Ifuse Implant SystemSI-BONE, Inc.2012—
+2K123850Ifuse Implant SystemSI-BONE, Inc.2013—
+2K131405Ifuse Implant SystemSI-BONE, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201110
201220
201320
201420
201540
201650
201720
201830
201950
202070
2021110
2022160
2023260
2024210
2025190
2026180
FIG. 1 — Lineage of K051309, 1993–2026Source: 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? (3)

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
*K0107832.0/2.4 Cannulated Screw System
Summary page 1
…Class II per 21 CFR section 888.3030 Product Code HWC IIRS Equivalent Device Osteomed Cannulated Screw System (K010783) Acumed Acutrak screws (K930834/K944330 Device Description The ROI Rods and Plates are utilized similar t…
Osteomed Corp.2001—
*K930834Acutract
Summary page 1
…Product Code HWC IIRS Equivalent Device Osteomed Cannulated Screw System (K010783) Acumed Acutrak screws (K930834/K944330 Device Description The ROI Rods and Plates are utilized similar to screws in treating fractures, non-unions and fusions.…
Acu Med, Inc.1993—
*K944330Acutrak Plus Fixation System
Summary page 1
…t Code HWC IIRS Equivalent Device Osteomed Cannulated Screw System (K010783) Acumed Acutrak screws (K930834/K944330 Device Description The ROI Rods and Plates are utilized similar to screws in treating fractures, non-unions and fusions. The rod…
Acu Med, Inc.1995—

Also cleared against K010783: 3 other devices →

What descends from it? (145)

See all 145

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

NumberDeviceApplicantDecidedDescendants
K080398SI Joint Fusion SystemSI-BONE, Inc.2008144

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 20, 2011Not classifiedZ-2589-2011Process controlTwo lots- one lot of Endo-Fuse Fusion Rod, 7x50mm was commingled one lot of Endo-Fuse(R) Fusion Rod, 7x70mm. Not all parts in each lot are affected. The commingled rod sizes might not be detected prior to surgery.
Apr 20, 2011Not classifiedZ-2590-2011Process controlTwo lots- one lot of Endo-Fuse Fusion Rod, 7x50mm was commingled one lot of Endo-Fuse(R) Fusion Rod, 7x70mm. Not all parts in each lot are affected. The commingled rod sizes might not be detected prior to surgery.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K080398 (SI-BONE, Inc., 2008) has gone furthest, with 144 descendants of its own.
  • 3 other devices also cite its predicate K010783.

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?

The use of the ROI Fusion Rods and Plates are generally indicated for the reduction and fixation of fractures appropriate for the size of the devices. They are indicated for use in the internal fixation of fractures, boney fusion, and non-unions. They are also indicated for reconstructive procedures where reduction and fixation of bone fragments are required (e.g. osteotomies).

Indications for use as stated in the FDA summary.

Also cleared against K010783

3 other devices cite the same predicate.

  • K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 20121 recall
  • K101030Modification to HBS Headless Bone ScrewBiopro, Inc. · 20102 recalls
  • K062863Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP · 2006

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/K051309 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051309: Roi Fusion Rods & Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051309

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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