510(k) Report

510(k) · Cleared

Cleared

SMV Scientific Cannulated Screws

K170021510(k) TraditionalCleared May 22, 2017139-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

Smv Scientific · HWC Screw, Fixation, Bone

Cleared on May 22, 2017 as substantially equivalent to K012945 (Synthes (Usa), 2001) and 5 other predicates after a 139-day review. Its family tree reaches back 1 generation to 1996. 8 later devices descend from it.

Decided
May 22, 2017
Review
139 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K962011 (1996). 6 ancestors in all. 8 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2001: 1 other ancestor1996: 3 other ancestors2020: 1 descendant cleared2021: 3 descendants cleared2024: 2 descendants cleared2023: 2 descendants clearedK962011 · Synthes 7.0/7.3 MM Cannulated Screws · Synthes (Usa) · 19961995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors 1 generation forward: 4 descendants2 generations forward: 4 descendants K962011 · Synthes 7.0/7.3 MM Cannulated Screws · Synthes (Usa) · 19960
  1. Root · 1 generation backK962011 Synthes 7.0/7.3 MM Cannulated ScrewsSynthes (Usa) · 1996
  2. This deviceK170021 SMV Scientific Cannulated ScrewsSmv Scientific · 2017
  3. Descendant · cites it directly · 3 of its ownK210754 Cannulated Fasteners and NutsOsteoCentric Technologies · 2021
  4. Descendant · cites it directly · 2 of its ownK211783 TriMed Threaded Intramedullary Nail SystemTriMed, Inc. · 2021
  5. Descendant · cites it directly · 2 of its ownK211290 Cannulated Fasteners and NutsOsteoCentric Technologies · 2021
  6. Descendant · 2 generations on · 1 of its ownK230749 TriMed Threaded Intramedullary Nail SystemTriMed, Inc. · 2023
  7. Descendant · 2 generations on · 0 of its ownK242691 OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies · 2024

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2020: 12021: 32023: 22024: 2
2020high 3 (2021) · low 0 (2022)2026

Most influential descendants

Showing 5 of 8 · See all
  • K210754Cannulated Fasteners and NutsOsteoCentric Technologies · 2021 · cites it directly3descendants
  • K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc. · 2021 · cites it directly2descendants
  • K211290Cannulated Fasteners and NutsOsteoCentric Technologies · 2021 · cites it directly2descendants
  • K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc. · 2023 · 2 generations on1descendant
  • K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies · 2024 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K962011Synthes 7.0/7.3 MM Cannulated ScrewsSynthes (Usa)1996—
0 (this device)K170021SMV Scientific Cannulated ScrewsSmv Scientific2017—
+1K210754Cannulated Fasteners and NutsOsteoCentric Technologies2021—
+1K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.2021—
+1K211290Cannulated Fasteners and NutsOsteoCentric Technologies2021—
+2K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.2023—
+2K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199630
200110
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202130
202320
202420
FIG. 1 — Lineage of K170021, 1996–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (6)

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
*K012945Synthes 2.4 MM Cannulated Screw
Summary page 5
…or Use e Materials of manufacture e Principles of operation Table 5-1: Predicate Devices 510k Trade or Proprietary or Model Manufacturer | Predicate Type Number | Name K012945 | 2.4mm Cannulated Screw Synthes Primary K962823 | 3.0mm Cannulated Screw Synthes Additional K963192 | 3.5mm & 4.0mm Cannulated S…
Synthes (Usa)20011
*K962823Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer
Summary page 5
…operation Table 5-1: Predicate Devices 510k Trade or Proprietary or Model Manufacturer | Predicate Type Number | Name K012945 | 2.4mm Cannulated Screw Synthes Primary K962823 | 3.0mm Cannulated Screw Synthes Additional K963192 | 3.5mm & 4.0mm Cannulated Screw | Synthes Additional K963172 | 4.5mm Cannula…
Synthes (Usa)1996—
*K963192Synthes Sterile 3.5 MM and 4.0 MM Cannulated Screws
Summary page 5
…or Proprietary or Model Manufacturer | Predicate Type Number | Name K012945 | 2.4mm Cannulated Screw Synthes Primary K962823 | 3.0mm Cannulated Screw Synthes Additional K963192 | 3.5mm & 4.0mm Cannulated Screw | Synthes Additional K963172 | 4.5mm Cannulated Screw Synthes Additional K962011 . K021932 6.5 &…
Synthes (Usa)1996—
*K963172Synthes Sterile 4.5 MM Cannulated Screws
Summary page 5
…| Name K012945 | 2.4mm Cannulated Screw Synthes Primary K962823 | 3.0mm Cannulated Screw Synthes Additional K963192 | 3.5mm & 4.0mm Cannulated Screw | Synthes Additional K963172 | 4.5mm Cannulated Screw Synthes Additional K962011 . K021932 6.5 & 7.3mm Cannulated Screw Synthes Additional CONCLUSION The ove…
Synthes (Usa)1996—
*K962011Synthes 7.0/7.3 MM Cannulated Screws
Summary page 5
…ary K962823 | 3.0mm Cannulated Screw Synthes Additional K963192 | 3.5mm & 4.0mm Cannulated Screw | Synthes Additional K963172 | 4.5mm Cannulated Screw Synthes Additional K962011 . K021932 6.5 & 7.3mm Cannulated Screw Synthes Additional CONCLUSION The overall technology characteristics and mechanical perfo…
Synthes (Usa)1996—
*K021932Synthes 6.5 MM Cannulated Screw
Summary page 5
…3 | 3.0mm Cannulated Screw Synthes Additional K963192 | 3.5mm & 4.0mm Cannulated Screw | Synthes Additional K963172 | 4.5mm Cannulated Screw Synthes Additional K962011 . K021932 6.5 & 7.3mm Cannulated Screw Synthes Additional CONCLUSION The overall technology characteristics and mechanical performance dat…
Synthes (Usa)20027

Also cleared against K012945: 9 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K210754Cannulated Fasteners and NutsOsteoCentric Technologies20213
K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212
K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212
K200259Headless Compression Screw SystemOsteocentric Extremities, LLC20200

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?

  • 2 of the 6 ancestors have a recall of any class.
  • Of its descendants, K210754 (OsteoCentric Technologies, 2021) has gone furthest, with 3 descendants of its own.
  • 9 other devices also cite its predicate K012945.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?

The SMV Scientific 2.4mm and 3.0mm Cannulated Screws are intended for fixation of fractures and non-unions of small bones and small bone arthrodesis. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies. The SMV Scientific 3.5mm Cannulated Screws are intended for fixation of small bones and small bone fragments, such as fractures of the metatarsals, arthrodeses of…

Read the full statement (145 words)

The SMV Scientific 2.4mm and 3.0mm Cannulated Screws are intended for fixation of

fractures and non-unions of small bones and small bone arthrodesis. Examples include, but are

not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions,

osteotomies, and bunionectomies.

The SMV Scientific 3.5mm Cannulated Screws are intended for fixation of small bones and

small bone fragments, such as fractures of the metatarsals, arthrodeses of the carpals and

phalanges, steochondritis dissecans, and ligament fixation.

The SMV Scientific 4.5mm Cannulated Screws is intended for fracture fixation of long bones

and long bone fragments.

The SMV Scientific 6.5mm and 7.3mm Cannulated Screws are intended for fracture fixation of

large bones and large bone fragments, femoral neck fractures, slipped capital femoral

epiphyses, as an adjunct to DHS in basilar neck fractures, tibial plateau fractures, ankle

arthrodesis, pediatric femoral neck fractures, intercondylar femur fractures, and subtalar

arthrodesis.

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

Also cleared against K012945

9 other devices cite the same predicate.

  • K161616DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm…Synthes USA Products, LLC · 2017
  • K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015
  • K142057Infix Cannulated Screw SystemInfix Medical, LLC · 2015
  • K124027Monster Screw SystemApogee Orthosolutions · 2013
  • K111008Microware Bone Plates and Bone ScrewMicroware Precision Co., Ltd. · 2012
  • K102343Emerge Medical Cannulated Screw Fixation SystemEmerge Medical · 2010

More from Smv Scientific

5 FDA decisions under this applicant name. See the company

  • K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific · 2016
  • K160603SMV Scientific Schanz ScrewsSmv Scientific · 2016
  • K152000SMV Scientific Bone Plate and Screw SystemSmv Scientific · 2015
  • K150981SMV Scientific Bone ScrewsSmv Scientific · 2015

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/K170021 · printed Nov 6, 2026

Cite this page

510(k) Report. “K170021: SMV Scientific Cannulated Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170021

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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