510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

Biopro GO-EZ Screw

K081149510(k) TraditionalCleared Aug 5, 2008105-day reviewClass II21 CFR 888.3040Recalls 14

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

Biopro, Inc. · HWC Screw, Fixation, Bone

Cleared on Aug 5, 2008 after a 105-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it. It has been recalled 14 times.

Decided
Aug 5, 2008
Review
105 days
Class
Class II
Product code
HWC
Recalls
14
Predicates
0

8 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2020: 2 descendants cleared2018: 1 descendant cleared2019: 1 descendant cleared2017: 1 descendant cleared2014: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant cleared20052010201520202025
  1. This deviceK081149 Biopro GO-EZ ScrewBiopro, Inc. · 2008
  2. Descendant · cites it directly · 4 of its ownK182949 Healix™ Compression Screw SystemNvision Biomedical Technologies, LLC · 2018
  3. Descendant · 2 generations on · 1 of its ownK202657 Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc. · 2020
  4. Descendant · 2 generations on · 0 of its ownK260291 Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc. · 2026
  5. Descendant · 2 generations on · 0 of its ownK242896 Caliber Intramedullary Fixation SystemNvision Biomedical Technologies · 2025
  6. Descendant · cites it directly · 0 of its ownK200914 Healix Compression Screw SystemNvision Biomedical Technologies, Inc. · 2020

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2014: 12017: 12018: 12019: 12020: 22025: 12026: 1
2014high 2 (2020) · low 0 (2015)2026

Most influential descendants

Showing 5 of 8 · See all
  • K182949Healix™ Compression Screw SystemNvision Biomedical Technologies, LLC · 2018 · cites it directly4descendants
  • K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc. · 2020 · 2 generations on1descendant
  • K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc. · 2026 · 2 generations on0descendants
  • K242896Caliber Intramedullary Fixation SystemNvision Biomedical Technologies · 2025 · 2 generations on0descendants
  • K200914Healix Compression Screw SystemNvision Biomedical Technologies, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K081149Biopro GO-EZ ScrewBiopro, Inc.2008—
+1K182949Healix™ Compression Screw SystemNvision Biomedical Technologies, LLC2018—
+2K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.2020—
+2K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.2026—
+2K242896Caliber Intramedullary Fixation SystemNvision Biomedical Technologies2025—
+1K200914Healix Compression Screw SystemNvision Biomedical Technologies, Inc.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201710
201810
201910
202020
202510
202610
FIG. 1 — Lineage of K081149, 2008–2026Source: 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 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K182949Healix™ Compression Screw SystemNvision Biomedical Technologies, LLC20184
K200914Healix Compression Screw SystemNvision Biomedical Technologies, Inc.20200
K182704WishBone Guided Growth SystemWishbone Medical20190
K173286Cannulated Screw Internal Fixation SystemLife Spine, Inc.20170
K142528AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mmAgent Medical, LLC20140

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

Recalls of this device

DateClassRecallRoot causeReason
Jun 25, 2019Class IIZ-2253-2019Nonconforming Material/ComponentManufacturing flaw in the sterile barrier system
Jun 25, 2019Class IIZ-2249-2019Nonconforming Material/ComponentManufacturing flaw in the sterile barrier system
Jun 25, 2019Class IIZ-2248-2019Nonconforming Material/ComponentManufacturing flaw in the sterile barrier system
Jun 25, 2019Class IIZ-2250-2019Nonconforming Material/ComponentManufacturing flaw in the sterile barrier system
Jun 25, 2019Class IIZ-2254-2019Nonconforming Material/ComponentManufacturing flaw in the sterile barrier system
Jun 25, 2019Class IIZ-2252-2019Nonconforming Material/ComponentManufacturing flaw in the sterile barrier system
Jun 25, 2019Class IIZ-2256-2019Nonconforming Material/ComponentManufacturing flaw in the sterile barrier system
Jun 25, 2019Class IIZ-2240-2019Nonconforming Material/ComponentManufacturing flaw in the sterile barrier system
Jun 25, 2019Class IIZ-2241-2019Nonconforming Material/ComponentManufacturing flaw in the sterile barrier system
Jun 25, 2019Class IIZ-2247-2019Nonconforming Material/ComponentManufacturing flaw in the sterile barrier system
Jun 25, 2019Class IIZ-2257-2019Nonconforming Material/ComponentManufacturing flaw in the sterile barrier system
Jun 25, 2019Class IIZ-2246-2019Nonconforming Material/ComponentManufacturing flaw in the sterile barrier system
Jun 25, 2019Class IIZ-2255-2019Nonconforming Material/ComponentManufacturing flaw in the sterile barrier system
Jun 25, 2019Class IIZ-2251-2019Nonconforming Material/ComponentManufacturing flaw in the sterile barrier system

The 5 latest of 14 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K182949 (Nvision Biomedical Technologies, LLC, 2018) has gone furthest, with 4 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. 2008, this device’s year, is highlighted.

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?

Bone Fractures, Osteotomies, Arthrodeses, Osteochrondritis and tendon reattachment. It is intended for but not limited to hand surgery, orthopedic surgery, plastic surgery and podiatric surgery but is not intended for use in the spine.

Indications for use as stated in the FDA 510(k) statement.

More from Biopro, Inc.

41 FDA decisions under this applicant name. See the company

  • K163627Shotel Ankle Arthrodesis Nail SystemBiopro, Inc. · 2017
  • K162674BioPro Foot Plating SystemsBiopro, Inc. · 2017
  • K132510Biopro - Infinity Plate Anchor SystemBiopro, Inc. · 2013
  • K130298Biopro Kwick-Wire Universal Screw SystemBiopro, Inc. · 2013
  • K121973Biopro Hemi-Edge Toe SystemBiopro, Inc. · 2012

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/K081149 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081149: Biopro GO-EZ Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081149

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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