510(k) Report

510(k) · Cleared

Cleared

Nexa Bone Screw System

K053394510(k) TraditionalCleared Dec 14, 20058-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

Nexa Orthopedics, Inc. · HWC Screw, Fixation, Bone

Cleared on Dec 14, 2005 as substantially equivalent to K043583 (Wrightmedicaltechnologyinc, 2005) after an 8-day review. Its family tree reaches back 1 generation to 2005. 9 later devices descend from it.

Decided
Dec 14, 2005
Review
8 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K043583 (2005). 9 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2007: 2 descendants cleared2017: 1 descendant cleared2015: 1 descendant cleared2006: 1 descendant cleared2014: 3 descendants cleared2025: 1 descendant clearedK043583 · Charlotte Snap-Off Screw, Models 45110001, 45110002, 45110003 · Wrightmedicaltechnologyinc · 200520052010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant K043583 · Charlotte Snap-Off Screw, Models 45110001, 45110002, 45110003 · Wrightmedicaltechnologyinc · 20050
  1. Root · 1 generation backK043583 Charlotte Snap-Off Screw, Models 45110001, 45110002, 45110003Wrightmedicaltechnologyinc · 2005
  2. This deviceK053394 Nexa Bone Screw SystemNexa Orthopedics, Inc. · 2005
  3. Descendant · cites it directly · 5 of its ownK061620 Ifs Cannulated Bone ScrewInternal Fixation Systems, Inc. · 2006
  4. Descendant · 2 generations on · 4 of its ownK063589 Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC · 2007
  5. Descendant · cites it directly · 3 of its ownK071035 Ifs Bone Fixation DevicesInternal Fixation Systems, Inc. · 2007
  6. Descendant · 2 generations on · 1 of its ownK130613 Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga · 2014
  7. Descendant · 3 generations on · 0 of its ownK252758 Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc. · 2025

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2006: 12007: 22014: 32015: 12017: 12025: 1
2006high 3 (2014) · low 0 (2008)2026

Most influential descendants

Showing 5 of 9 · See all
  • K061620Ifs Cannulated Bone ScrewInternal Fixation Systems, Inc. · 2006 · cites it directly5descendants
  • K063589Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC · 2007 · 2 generations on4descendants
  • K071035Ifs Bone Fixation DevicesInternal Fixation Systems, Inc. · 2007 · cites it directly3descendants
  • K130613Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga · 2014 · 2 generations on1descendant
  • K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K043583Charlotte Snap-Off Screw, Models 45110001, 45110002, 45110003Wrightmedicaltechnologyinc2005—
0 (this device)K053394Nexa Bone Screw SystemNexa Orthopedics, Inc.2005—
+1K061620Ifs Cannulated Bone ScrewInternal Fixation Systems, Inc.2006—
+2K063589Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC2007—
+1K071035Ifs Bone Fixation DevicesInternal Fixation Systems, Inc.2007—
+2K130613Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga2014—
+3K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200720
201430
201510
201710
202510
FIG. 1 — Lineage of K053394, 2005–2025Source: 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? (1)

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
*K043583Charlotte Snap-Off Screw, Models 45110001, 45110002, 45110003
Summary page 1
…rthopedic Regulation Number 888.3040 Product Code: 87 HWC Predicate Device: K043583 - Charlotte Snap-off Screw Systeni Registration Number:…
Wrightmedicaltechnologyinc2005—

Also cleared against K043583: 6 other devices →

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K061620Ifs Cannulated Bone ScrewInternal Fixation Systems, Inc.20065
K071035Ifs Bone Fixation DevicesInternal Fixation Systems, Inc.20073
K163627Shotel Ankle Arthrodesis Nail SystemBiopro, Inc.20170
K150871ForeFoot STP SystemTornier, Inc.20150
K132911I.B.S Snap-Off Screw / Solafix Snap-Off ScrewIn2bones Sas20140

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?

  • Its one ancestor has no recall.
  • Of its descendants, K061620 (Internal Fixation Systems, Inc., 2006) has gone furthest, with 5 descendants of its own.
  • 6 other devices also cite its predicate K043583.

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 Nexa bone screw system provides fixation of fractures, fusions, or osteotomies of bones of the hand and foot.

Indications for use as stated in the FDA summary.

Also cleared against K043583

6 other devices cite the same predicate.

  • K170038FuzeFix Screw SystemFusion Orthopedics, LLC · 2017
  • K163038EPIC Extremity Snap-Off ScrewEpic Extremity, LLC · 2017
  • K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
  • K133713Charlotte (TM) Snap-Off ScrewWrightmedicaltechnologyinc · 2014
  • K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 20132 recalls
  • K050819Charlotte Snap-Off ScrewWrightmedicaltechnologyinc · 2005

More from Nexa Orthopedics, Inc.

16 FDA decisions under this applicant name. See the company

  • K072710Nexfix Compression PinNexa Orthopedics, Inc. · 2007
  • K071147Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc. · 2007
  • K070688Nexfix Compression StapleNexa Orthopedics, Inc. · 2007
  • K060386Nexa Carpo Metacarpal ImplantNexa Orthopedics, Inc. · 2006
  • K060071Nexa Compression ScrewNexa Orthopedics, Inc. · 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/K053394 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053394: Nexa Bone 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/K053394

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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