510(k) Report

510(k) · Cleared

Cleared

Reunite Screws

K992301510(k) TraditionalCleared Sep 1, 199955-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

Biomet Manufacturing, Inc. · HWC Screw, Fixation, Bone

Cleared on Sep 1, 1999 after a 55-day review. The FDA summary names no predicate by number. 29 later devices descend from it.

Decided
Sep 1, 1999
Review
55 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
0

29 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2005: 3 descendants cleared2010: 1 descendant cleared2001: 1 descendant cleared2003: 1 descendant cleared2007: 1 descendant cleared2013: 1 descendant cleared2015: 1 descendant cleared2008: 1 descendant cleared2016: 1 descendant cleared2024: 2 descendants cleared2020: 3 descendants cleared2021: 2 descendants cleared2012: 1 descendant cleared2025: 1 descendant cleared2018: 1 descendant cleared2023: 2 descendants cleared2022: 2 descendants cleared2019: 2 descendants cleared2026: 1 descendant cleared1995200020052010201520202025
  1. This deviceK992301 Reunite ScrewsBiomet Manufacturing, Inc. · 1999
  2. Descendant · cites it directly · 19 of its ownK043142 Inion Otps Biodegradable Mini Plating SystemInion, Ltd. · 2005
  3. Descendant · 2 generations on · 17 of its ownK123672 Inion Freedomscrew (Alternative Marketing Name: Inion Otps…Inion OY · 2013
  4. Descendant · 3 generations on · 8 of its ownK160304 OsteoBullet Compression ScrewPhalanx Innovations · 2016
  5. Descendant · 3 generations on · 6 of its ownK193660 OSSIOfiber™ Compression ScrewsOSSIO, Ltd. · 2020
  6. Descendant · 4 generations on · 4 of its ownK221193 OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd. · 2022

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2001: 12003: 12005: 32006: 12007: 12008: 12010: 12012: 12013: 12015: 12016: 12018: 12019: 22020: 32021: 22022: 22023: 22024: 22025: 12026: 1
2001high 3 (2005) · low 0 (2002)2026

Most influential descendants

Showing 5 of 29 · See all
  • K043142Inion Otps Biodegradable Mini Plating SystemInion, Ltd. · 2005 · cites it directly19descendants
  • K123672Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)Inion OY · 2013 · 2 generations on17descendants
  • K160304OsteoBullet Compression ScrewPhalanx Innovations · 2016 · 3 generations on8descendants
  • K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd. · 2020 · 3 generations on6descendants
  • K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd. · 2022 · 4 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K992301Reunite ScrewsBiomet Manufacturing, Inc.1999—
+1K043142Inion Otps Biodegradable Mini Plating SystemInion, Ltd.2005—
+2K123672Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)Inion OY2013—
+3K160304OsteoBullet Compression ScrewPhalanx Innovations2016—
+3K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd.2020—
+4K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200310
200530
200610
200710
200810
201010
201210
201310
201510
201610
201810
201920
202030
202120
202220
202320
202420
202510
202610
FIG. 1 — Lineage of K992301, 1999–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (29)

See all 29

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

NumberDeviceApplicantDecidedDescendants
K043142Inion Otps Biodegradable Mini Plating SystemInion, Ltd.200519
K023887Inion Otps Biodegradable Mini Plating SystemInion, Ltd.20034
K102777Twistcut Endosorb ScrewsMerete Medical GmbH20100
K061763Arc Surgical Biotrak ScrewArc Surgical, LLC20060
K050388Refix Internal Fracture Fixation ScrewsXtremi-T, LLC20050
K043176Arc Surgical Resorbable Compression Screw SystemArc Surgical, LLC20050
K011451Reunite Fusion ScrewBiomet, Inc.20010

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, K043142 (Inion, Ltd., 2005) has gone furthest, with 19 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—

What is it indicated for?

The ReUnite™ Screws are indicated for use in the presence of appropriate immobilization in the following procedures:

1. correction of hallux valgus (bunion)

2. repair of metacarpal and phalangeal fusion and fractures

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Biomet Manufacturing, Inc.

32 FDA decisions under this applicant name. See the company

  • K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc. · 20131 recall
  • K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc. · 2012
  • K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc. · 2011
  • K080685Hiploc Compression Hip ScrewBiomet Manufacturing, Inc. · 20084 recalls
  • K080088Biomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc. · 20088 recalls

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/K992301 · printed Nov 6, 2026

Cite this page

510(k) Report. “K992301: Reunite Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992301

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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