510(k) Report

510(k) · Cleared

Cleared

Refix Internal Fracture Fixation Screws

K050388510(k) TraditionalCleared Sep 7, 2005204-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

Xtremi-T, LLC · HWC Screw, Fixation, Bone

Cleared on Sep 7, 2005 as substantially equivalent to K041189 (Arthrex, Inc., 2004) and 11 other predicates after a 204-day review. Its family tree reaches back 6 generations to 1979.

Decided
Sep 7, 2005
Review
204 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
12

Its longest line of descent runs back 6 generations to K792022 (1979). 19 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 2 other ancestors2003: 2 other ancestors2001: 1 other ancestor1999: 2 other ancestors1997: 2 other ancestors1996: 2 other ancestors1995: 2 other ancestorsK792022 · Herbert Bone Screw · Zimmer, Inc. · 1979 · recalledK974876 · Bionx Distal Radius Screw · Bionx Implants, Inc. · 1998K992947 · Cannulated Smartscrew Models 224540C, 224570C · Bionx Implants, Ltd. · 1999K012001 · Smartscrew · Bionx Implants, Ltd. · 2001K023022 · Nugen FX Screw · Bionx Implants, Inc. · 2002K032447 · Cannulated Nugen FX Screw Fully Threaded, Cannulated Nugen FX Screw Partially Threaded · Linvatec Biomaterials, Ltd. · 20041975198019851990199520002005
Other ancestors, by generation 1 generation back: 7 other ancestors2 generations back: 6 other ancestors K032447 · Cannulated Nugen FX Screw Fully Threaded, Cannulated Nugen FX Screw Partially Threaded · Linvatec Biomaterials, Ltd. · 2004K023022 · Nugen FX Screw · Bionx Implants, Inc. · 2002K012001 · Smartscrew · Bionx Implants, Ltd. · 2001K992947 · Cannulated Smartscrew Models 224540C, 224570C · Bionx Implants, Ltd. · 1999K974876 · Bionx Distal Radius Screw · Bionx Implants, Inc. · 1998K792022 · Herbert Bone Screw · Zimmer, Inc. · 1979 · recalled−50
  1. Root · 6 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
  2. 5 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
  3. 4 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
  4. 3 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
  5. 2 generations backK023022 Nugen FX ScrewBionx Implants, Inc. · 2002
  6. 1 generation backK032447 Cannulated Nugen FX Screw Fully Threaded, Cannulated Nugen FX Screw…Linvatec Biomaterials, Ltd. · 2004
  7. This deviceK050388 Refix Internal Fracture Fixation ScrewsXtremi-T, LLC · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K792022Herbert Bone ScrewZimmer, Inc.19796
−5K974876Bionx Distal Radius ScrewBionx Implants, Inc.1998—
−4K992947Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd.1999—
−3K012001SmartscrewBionx Implants, Ltd.2001—
−2K023022Nugen FX ScrewBionx Implants, Inc.2002—
−1K032447Cannulated Nugen FX Screw Fully Threaded, Cannulated Nugen FX Screw Partially…Linvatec Biomaterials, Ltd.2004—
0 (this device)K050388Refix Internal Fracture Fixation ScrewsXtremi-T, LLC2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199520
199620
199720
199920
200110
200320
200420
FIG. 1 — Lineage of K050388, 1979–2005Source: 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
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What was it cleared against? (12)

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
*K041189Arthrex Trimit Family
Summary page 2
…uivalence of the ReFIX Screws is based on the equivalence in intended use, materials, operational principals, and indications to: DEVICE Manufacturer Trade Name K041189 Arthrex TRIMIt K992301 Biomet Reunite Screw K964970 Biomet Bonescrew K042295 Bionx…
Arthrex, Inc.2004—
*K992301Reunite Screws
Summary page 2
…ased on the equivalence in intended use, materials, operational principals, and indications to: DEVICE Manufacturer Trade Name K041189 Arthrex TRIMIt K992301 Biomet Reunite Screw K964970 Biomet Bonescrew K042295 Bionx Smartscrew K032447 Bionx…
Biomet Manufacturing, Inc.1999—
*K964970Biomet Bone Screw
Summary page 2
…materials, operational principals, and indications to: DEVICE Manufacturer Trade Name K041189 Arthrex TRIMIt K992301 Biomet Reunite Screw K964970 Biomet Bonescrew K042295 Bionx Smartscrew K032447 Bionx Nugen FX K023022 Bionx…
Biomet, Inc.1997—
*K042295Smartscrew II, Models 232010, 232012, 232014, 232016, 232018, 232020
Summary page 2
…d indications to: DEVICE Manufacturer Trade Name K041189 Arthrex TRIMIt K992301 Biomet Reunite Screw K964970 Biomet Bonescrew K042295 Bionx Smartscrew K032447 Bionx Nugen FX K023022 Bionx Nugen FX K012001 Bionx S…
Linvatec Biomaterials, Ltd.2004—
*K032447Cannulated Nugen FX Screw Fully Threaded, Cannulated Nugen FX Screw Partially Threaded
Summary page 2
…turer Trade Name K041189 Arthrex TRIMIt K992301 Biomet Reunite Screw K964970 Biomet Bonescrew K042295 Bionx Smartscrew K032447 Bionx Nugen FX K023022 Bionx Nugen FX K012001 Bionx Smartscrew K003077 Bionx S…
Linvatec Biomaterials, Ltd.2004—
*K023022Nugen FX Screw
Summary page 2
…ex TRIMIt K992301 Biomet Reunite Screw K964970 Biomet Bonescrew K042295 Bionx Smartscrew K032447 Bionx Nugen FX K023022 Bionx Nugen FX K012001 Bionx Smartscrew K003077 Bionx Smartscrew K992947 Bionx…
Bionx Implants, Inc.2002—
*K012001Smartscrew
Summary page 2
…Reunite Screw K964970 Biomet Bonescrew K042295 Bionx Smartscrew K032447 Bionx Nugen FX K023022 Bionx Nugen FX K012001 Bionx Smartscrew K003077 Bionx Smartscrew K992947 Bionx Smartscrew K974876 Bionx…
Bionx Implants, Ltd.2001—
*K003077Smartscrew Model 222006...227510
Summary page 2
…et Bonescrew K042295 Bionx Smartscrew K032447 Bionx Nugen FX K023022 Bionx Nugen FX K012001 Bionx Smartscrew K003077 Bionx Smartscrew K992947 Bionx Smartscrew K974876 Bionx Distal Radius Screw K030900 Ini…
Bionx Implants, Ltd.2001—
*K992947Cannulated Smartscrew Models 224540C, 224570C
Summary page 2
…Smartscrew K032447 Bionx Nugen FX K023022 Bionx Nugen FX K012001 Bionx Smartscrew K003077 Bionx Smartscrew K992947 Bionx Smartscrew K974876 Bionx Distal Radius Screw K030900 Inion OTPS System K023887 In…
Bionx Implants, Ltd.1999—
*K974876Bionx Distal Radius Screw
Summary page 2
…Nugen FX K023022 Bionx Nugen FX K012001 Bionx Smartscrew K003077 Bionx Smartscrew K992947 Bionx Smartscrew K974876 Bionx Distal Radius Screw K030900 Inion OTPS System K023887 Inion OTPS System END OF 510…
Bionx Implants, Inc.1998—
*K030900Inion Otps Biodegradable Fixaton System
Summary page 2
…ugen FX K012001 Bionx Smartscrew K003077 Bionx Smartscrew K992947 Bionx Smartscrew K974876 Bionx Distal Radius Screw K030900 Inion OTPS System K023887 Inion OTPS System END OF 510(K) SUMMARY Xtremi-T, LLC…
Inion, Ltd.2003—
*K023887Inion Otps Biodegradable Mini Plating System
Summary page 2
…tscrew K003077 Bionx Smartscrew K992947 Bionx Smartscrew K974876 Bionx Distal Radius Screw K030900 Inion OTPS System K023887 Inion OTPS System END OF 510(K) SUMMARY Xtremi-T, LLC…
Inion, Ltd.2003—

Also cleared against K041189: 3 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 26 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
  • 1 of the 19 ancestors has a recall of any class.
  • 3 other devices also cite its predicate K041189.

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?

ReFIX Screws are intended for use in the fixation and/or alignment of fragments of

fractured non-load bearing bones, osteotomies and arthrodeses; and fixation and/or

alignment of apical fragments, osteochondral fragments and cancellous/non-load

bearing bone fragments.

For example, ReFIX Screws are intended for use in fractures of the ankle, colles,

distal radius, hand and wrist, humeral condyle, malleolus, metacarpals, olecranon,

phalanges and the radial head; fusions of metacarpals, metatarsals and phalanges; and

correction of hallux valgus.

Indications for use as stated in the FDA summary.

Also cleared against K041189

3 other devices cite the same predicate.

  • K211770R3ACT Stabilization SystemParagon 28, Inc. · 2021
  • K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical · 2015
  • K061925Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc. · 2006

More from Xtremi-T, LLC

2 FDA decisions under this applicant name. See the company

  • K043339Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models 2070LG, 2770LG, 3570LG, 4570LGXtremi-T, LLC · 2005

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The HWC category page

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  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
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  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K050388 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050388: Refix Internal Fracture Fixation Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050388

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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