510(k) Report

510(k) · Cleared

Cleared

VERTEX Nitinol Staple System

K182943510(k) TraditionalCleared Apr 4, 2019163-day reviewClass II21 CFR 888.3030

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

Nvision Biomedical Technologies, LLC · JDR Staple, Fixation, Bone

Cleared on Apr 4, 2019 as substantially equivalent to K142111 (Novatsep, 2014) and 2 other predicates after a 163-day review. Its family tree reaches back 5 generations to 1990.

Decided
Apr 4, 2019
Review
163 days
Class
Class II
Product code
JDR
Recalls
None
Predicates
3

Its longest line of descent runs back 5 generations to K902307 (1990). 16 ancestors in all, the oldest K895117 (1990). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2014: 2 other ancestors2001: 2 other ancestors2013: 1 other ancestor2000: 1 other ancestor1999: 1 other ancestor1997: 1 other ancestor1990: 1 other ancestor2010: 1 other ancestor2007: 1 other ancestorK902307 · Shaw II Hemostatic Surgery System · Hemostatic Surgery Corp. · 1990 · recalledK993714 · Memograph Staple, Warm System · Biomedical Ent., Inc. · 2000K124022 · Speed Shift · Biomedical Enterprises, Inc. · 2013K133780 · Speed XL · Biomedical Ent., Inc. · 2014K142292 · Speed, Speed Shift, Speed Titan, Speed Arc · Biomedical Enterprises, Inc. · 2014 · recalled1990199520002005201020152020
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 7 other ancestors3 generations back: 2 other ancestors K142292 · Speed, Speed Shift, Speed Titan, Speed Arc · Biomedical Enterprises, Inc. · 2014 · recalledK133780 · Speed XL · Biomedical Ent., Inc. · 2014K124022 · Speed Shift · Biomedical Enterprises, Inc. · 2013K993714 · Memograph Staple, Warm System · Biomedical Ent., Inc. · 2000K902307 · Shaw II Hemostatic Surgery System · Hemostatic Surgery Corp. · 1990 · recalled−50
  1. Root · 5 generations backK902307 Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp. · 1990 · Recalled
  2. 4 generations backK993714 Memograph Staple, Warm SystemBiomedical Ent., Inc. · 2000
  3. 3 generations backK124022 Speed ShiftBiomedical Enterprises, Inc. · 2013
  4. 2 generations backK133780 Speed XLBiomedical Ent., Inc. · 2014
  5. 1 generation backK142292 Speed, Speed Shift, Speed Titan, Speed ArcBiomedical Enterprises, Inc. · 2014 · Recalled
  6. This deviceK182943 VERTEX Nitinol Staple SystemNvision Biomedical Technologies, LLC · 2019
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K902307Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp.19902
−4K993714Memograph Staple, Warm SystemBiomedical Ent., Inc.2000—
−3K124022Speed ShiftBiomedical Enterprises, Inc.2013—
−2K133780Speed XLBiomedical Ent., Inc.2014—
−1K142292Speed, Speed Shift, Speed Titan, Speed ArcBiomedical Enterprises, Inc.20143
0 (this device)K182943VERTEX Nitinol Staple SystemNvision Biomedical Technologies, LLC2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199710
199910
200010
200120
200710
201010
201310
201420
FIG. 1 — Lineage of K182943, 1990–2019Source: 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 JDR? 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 JDR device

  1. #1 K243658 TMC Compression Implant Systemscore 16.7 · 18 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
*K142111Arcad Compressive Osteosynthesis Staple, Express Compressive Osteosynthesis Staple
Summary page 5
…aple System is substantially equivalent to the following predicates: 510(k) Number Predicate Device Name / Manufacturer Primary Predicate K142111 Novastep Arcad Compressive Osteosynthesis Staple  K011716 New Deal (Integra) Uni-Clip Staple*…
Novatsep2014—
*K011716The Uni-Clip Staple
Summary page 5
…icate Device Name / Manufacturer Primary Predicate K142111 Novastep Arcad Compressive Osteosynthesis Staple  K011716 New Deal (Integra) Uni-Clip Staple* K142292 BioMedical Enterprises, Inc Speed Staple *Additional Uni-Clip Staple cle…
New Deal, S.A.20011
*K142292Speed, Speed Shift, Speed Titan, Speed Arc
Summary page 5
…Primary Predicate K142111 Novastep Arcad Compressive Osteosynthesis Staple  K011716 New Deal (Integra) Uni-Clip Staple* K142292 BioMedical Enterprises, Inc Speed Staple *Additional Uni-Clip Staple clearances include K991482 and K061594 SUMMARY OF NON-C…
Biomedical Enterprises, Inc.20143

Also cleared against K142111: 1 other device →

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 29 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
  • 4 of the 16 ancestors have a recall of any class.
  • 1 other device also cites its predicate K142111.

How does its category compare?

All JDR devices

JDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · JDR

3in 2025

2007: 82008: 52010: 22011: 12012: 12013: 92014: 112015: 72016: 62017: 92018: 82019: 52020: 42021: 32022: 52023: 92024: 42025: 32026 (partial year): 2
2007high 11 (2014) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDR

65in 2025

2007: 70 days median2008: 89 days median2013: 137 days median2014: 97 days median2015: 111 days median2016: 101 days median2017: 172 days median2018: 107 days median2019: 149 days median2020: 161 days median2021: 62 days median2022: 107 days median2023: 72 days median2024: 29 days median2025: 65 days median
2007high 172 (2017) · low 29 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JDR

11in 2022

2008: 12015: 12018: 12020: 12022: 112026 (partial year): 2
2007high 11 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JDR

314in 2025

2007: 32008: 142009: 102010: 352011: 622012: 342013: 272014: 492015: 482016: 762017: 1162018: 2392019: 2422020: 2342021: 2102022: 2022023: 1752024: 2062025: 314
2007high 314 (2025) · low 3 (2007)2025

MAUDE reports naming product code JDR, 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
200787003
2008589114
20090—010
20102—035
20111—062
20121—034
20139137027
20141197049
20157111148
20166101076
201791720116
201881071239
201951490242
202041611234
20213620210
2022510711202
20239720175
20244290206
20253650314
20262—2—

What is it indicated for?

The VERTEX Nitinol Staple System is indicated for bone fragments and osteotomy fixation and joint arthrodesis of the hand or foot.

Indications for use as stated in the FDA summary.

Also cleared against K142111

1 other device cites the same predicate.

  • K230724arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesNovastep · 2023

More from Nvision Biomedical Technologies, LLC

10 FDA decisions under this applicant name. See the company

  • K183055Vector Hammertoe Correction SystemNvision Biomedical Technologies, LLC · 2019
  • K182949Healix™ Compression Screw SystemNvision Biomedical Technologies, LLC · 2018
  • K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC · 2018
  • K173091Boundary Anterior Lumbar Buttress PlateNvision Biomedical Technologies, LLC · 2017
  • K170074nvcNvision Biomedical Technologies, LLC · 2017

Recent decisions in JDR

The JDR category page

  • K262451Arthrex DynaNite StaplesArthrex, Inc. · 2026
  • K261121Megalodon Dynamic Compression SystemParagon 28, Inc. · 2026
  • K250712Linkt Compression Staple SystemTrax Surgical · 2025
  • K243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LP · 2025
  • K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc. · 2025

https://510kreport.com/device/K182943 · printed Nov 6, 2026

Cite this page

510(k) Report. “K182943: VERTEX Nitinol Staple System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182943

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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