510(k) Report

510(k) · Cleared

Cleared

OsteoMed Cannulated Screw System

K151021510(k) SpecialCleared Jul 15, 201590-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

Osteomed Corp. · HWC Screw, Fixation, Bone

Cleared on Jul 15, 2015 as substantially equivalent to K062863 (Osteomed LP, 2006) after a 90-day review. Its family tree reaches back 3 generations to 2002. 16 later devices descend from it.

Decided
Jul 15, 2015
Review
90 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K013888 (2002). 6 ancestors in all, the oldest K954330 (1995). 16 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1996: 1 other ancestor1995: 1 other ancestor2017: 2 descendants cleared2018: 2 descendants cleared2016: 1 descendant cleared2022: 3 descendants cleared2026: 4 descendants cleared2023: 1 descendant cleared2021: 1 descendant cleared2024: 1 descendant cleared2025: 1 descendant clearedReference device: K954330 · Super Screw 3.5 MM · Osteomed Corp. · 1995K013888 · Fixation (Steinmann) Pins · Miltex, Inc. · 2002K031050 · PCW Percutaneous Compression Wire · Millennium Medical Technologies, Inc. · 2003K062863 · Osteomed Extended 2.0/2.4CANNULATED Screw System · Osteomed LP · 20061995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 3 other ancestors 1 generation forward: 5 descendants2 generations forward: 6 descendants3 generations forward: 4 descendants4 generations forward: 1 descendant K062863 · Osteomed Extended 2.0/2.4CANNULATED Screw System · Osteomed LP · 2006K031050 · PCW Percutaneous Compression Wire · Millennium Medical Technologies, Inc. · 2003K013888 · Fixation (Steinmann) Pins · Miltex, Inc. · 20020
  1. Root · 3 generations backK013888 Fixation (Steinmann) PinsMiltex, Inc. · 2002
  2. 2 generations backK031050 PCW Percutaneous Compression WireMillennium Medical Technologies, Inc. · 2003
  3. 1 generation backK062863 Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP · 2006
  4. This deviceK151021 OsteoMed Cannulated Screw SystemOsteomed Corp. · 2015
  5. Descendant · cites it directly · 7 of its ownK153338 Tiger Cannulated Screw SystemTrilliant Surgical, Ltd. · 2016 · Recalled
  6. Descendant · 2 generations on · 5 of its ownK203595 DynaFuse Fixation SystemMedShape, Inc. · 2022
  7. Descendant · cites it directly · 3 of its ownK163303 OsteoMed ExtremiFix Mid and Large Screw SystemOsteomed, LLC · 2017
  8. Descendant · 3 generations on · 1 of its ownK254110 DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip…MedShape, Inc. · 2026
  9. Descendant · 3 generations on · 1 of its ownK233567 OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho · 2024

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2016: 12017: 22018: 22021: 12022: 32023: 12024: 12025: 12026: 4
2016high 4 (2026) · low 0 (2019)2026

Most influential descendants

Showing 5 of 16 · See all
  • K153338Tiger Cannulated Screw SystemTrilliant Surgical, Ltd. · 2016 · cites it directly7descendants
  • K203595DynaFuse Fixation SystemMedShape, Inc. · 2022 · 2 generations on5descendants
  • K163303OsteoMed ExtremiFix Mid and Large Screw SystemOsteomed, LLC · 2017 · cites it directly3descendants
  • K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc. · 2026 · 3 generations on1descendant
  • K233567OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho · 2024 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K013888Fixation (Steinmann) PinsMiltex, Inc.2002—
−2K031050PCW Percutaneous Compression WireMillennium Medical Technologies, Inc.2003—
−1K062863Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP2006—
0 (this device)K151021OsteoMed Cannulated Screw SystemOsteomed Corp.2015—
+1K153338Tiger Cannulated Screw SystemTrilliant Surgical, Ltd.20164
+2K203595DynaFuse Fixation SystemMedShape, Inc.2022—
+1K163303OsteoMed ExtremiFix Mid and Large Screw SystemOsteomed, LLC2017—
+3K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte…MedShape, Inc.2026—
+3K233567OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199610
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201720
201820
202110
202230
202310
202410
202510
202640
FIG. 1 — Lineage of K151021, 2002–2026Source: 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 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
*K062863Osteomed Extended 2.0/2.4CANNULATED Screw System
Summary page 4
…threaded metallic bone fixation fastener Code: HWC Predicate Device: OsteoMed Extended 2.0/2.4 Cannulated Screw System, K062863 Classification Name: Smooth or threaded metallic fixation fastener (21CFR 888.3040, Product Code HWC)…
Osteomed LP2006—
†K954330Super Screw 3.5 MMOsteomed Corp.1995—

Also cleared against K062863: 7 other devices →

What descends from it? (16)

See all 16

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

NumberDeviceApplicantDecidedDescendants
K153338Tiger Cannulated Screw SystemTrilliant Surgical, Ltd.20167
K163303OsteoMed ExtremiFix Mid and Large Screw SystemOsteomed, LLC20173
K170038FuzeFix Screw SystemFusion Orthopedics, LLC20171
K182989AURORA™ Screw SystemMiRus, LLC20180
K171690Trident Extremity Fixation SystemTrident Orthopedics20180

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 13 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K153338 (Trilliant Surgical, Ltd., 2016) has gone furthest, with 7 descendants of its own.
  • 7 other devices also cite its predicate K062863.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 OsteoMed Cannulated Screw System is indicated for bone fixation of hand and foot following trauma or osteotomy. Screws and washers are intended for single use only.

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 K062863

7 other devices cite the same predicate.

  • K152527Integra DigiFuse Cannulated Intramedullary Fusion SystemAscension Orthopedics · 2015
  • K140283Osteomed Extremifuse SystemOsteomed · 2014
  • K130412Osteomed Extremifuse SystemOsteomed · 2013
  • K120015Osteomed Wrist Plating SystemOsteomed LP · 2012
  • K111536Metasurg Digifuse ImplantMetasurg · 2011
  • K103705Low Profile ScrewsArthrex, Inc. · 2011

More from Osteomed Corp.

27 FDA decisions under this applicant name. See the company

  • K022277Osteomed Cranial Flap Fixation SystemOsteomed Corp. · 2003
  • K022887Interphalangeal Flexible Stabilizing Rod SystemOsteomed Corp. · 2002
  • K022886Metatarsophalangeal Flexible Stabilizing Rod SystemOsteomed Corp. · 2002
  • K0232601.2MM Osteomed Auto-Drive Screw SystemOsteomed Corp. · 2002
  • K013618Intraoral Mandibular Distraction SystemOsteomed Corp. · 2002

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/K151021 · printed Nov 6, 2026

Cite this page

510(k) Report. “K151021: OsteoMed Cannulated 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/K151021

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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