510(k) Report

510(k) · Cleared

Cleared

Osteo 4.0MM Cannulated Screw System

K983165510(k) TraditionalCleared Dec 3, 199884-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

Osteonics Corp. · HWC Screw, Fixation, Bone

Cleared on Dec 3, 1998 after an 84-day review. The FDA summary names its predicate without a number. 42 later devices descend from it.

Decided
Dec 3, 1998
Review
84 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
0

42 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared2009: 1 descendant cleared2021: 3 descendants cleared2017: 3 descendants cleared2015: 1 descendant cleared2020: 5 descendants cleared2019: 2 descendants cleared2022: 8 descendants cleared2024: 4 descendants cleared2023: 8 descendants cleared2025: 2 descendants cleared2026: 4 descendants cleared1995200020052010201520202025
  1. This deviceK983165 Osteo 4.0MM Cannulated Screw SystemOsteonics Corp. · 1998
  2. Descendant · cites it directly · 36 of its ownK123890 Acumed Cannulated Screw SystemAcumed, LLC · 2013 · Recalled
  3. Descendant · 2 generations on · 21 of its ownK190586 Monster® Screw SystemParagon 28, Inc. · 2019
  4. Descendant · 3 generations on · 9 of its ownK200398 AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020
  5. Descendant · 2 generations on · 9 of its ownK150693 PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015
  6. Descendant · 4 generations on · 8 of its ownK222381 PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti…Stryker GmbH · 2023

Showing 5 of 42 descendants. See all descendants

Descendants cleared per year

2009: 12013: 12015: 12017: 32019: 22020: 52021: 32022: 82023: 82024: 42025: 22026: 4
2009high 8 (2022) · low 0 (2010)2026

Most influential descendants

Showing 5 of 42 · See all
  • K123890Acumed Cannulated Screw SystemAcumed, LLC · 2013 · cites it directly36descendants
  • K190586Monster® Screw SystemParagon 28, Inc. · 2019 · 2 generations on21descendants
  • K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020 · 3 generations on9descendants
  • K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015 · 2 generations on9descendants
  • K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH · 2023 · 4 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K983165Osteo 4.0MM Cannulated Screw SystemOsteonics Corp.1998—
+1K123890Acumed Cannulated Screw SystemAcumed, LLC20132
+2K190586Monster® Screw SystemParagon 28, Inc.2019—
+3K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH2020—
+2K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC2015—
+4K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker…Stryker GmbH2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201310
201510
201730
201920
202050
202130
202280
202380
202440
202520
202640
FIG. 1 — Lineage of K983165, 1998–2026Source: 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? (2)

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
*—Richards 4.0mm Cannulated Screw
Named without a submission number
—
*—ACE Medical Titanium 3.5/4.0mm Small Fragment System
Named without a submission number
—

What descends from it? (42)

See all 42

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

NumberDeviceApplicantDecidedDescendants
K123890Acumed Cannulated Screw SystemAcumed, LLC201336
K081813Universal Compression Fracture Repair SystemU.S. Implant Solutions, LLC20094

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?

  • Of its descendants, K123890 (Acumed, LLC, 2013) has gone furthest, with 36 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.

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 indications for the use of these cannulated screws, in keeping with those of other legally marketed cannulated screws, are as follows. The Osteo 4.0mm Cannulated Screw System is indicated for osteochrondritis dissecans, ligament fixation, and long and small bone fracture fixation, which may include the following: Fractures of the olecranon, distal humerus Fractures of the ulna and radius Patellar fractures Distal tibia and pilon fractures Fractures…

Read the full statement (110 words)

The indications for the use of these cannulated screws, in keeping with those of other legally marketed cannulated screws, are as follows.

The Osteo 4.0mm Cannulated Screw System is indicated for osteochrondritis dissecans, ligament fixation, and long and small bone fracture fixation, which may include the following:

Fractures of the olecranon, distal humerus

Fractures of the ulna and radius

Patellar fractures

Distal tibia and pilon fractures

Fractures of the tarsals and metatarsals

Tarso-metatarsal and metatarso-phalangeal arthrodeses

Metatarsal and phalangeal osteotomies

Fractures of the posterior wall of the acetabulum and other fractures of the pelvic ring

Fractures of the fibula, medial malleolus, and os calcis

Other small fragment, cancellous bone fractures

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

More from Osteonics Corp.

178 FDA decisions under this applicant name. See the company

  • K983657Osteonics Series 7000 AD Tibial TrayOsteonics Corp. · 2000
  • K980070Osteonics HA-Coated DevicesOsteonics Corp. · 1999
  • K984375Osteonics Spinal System - Sacral Offset Connector AssemblyOsteonics Corp. · 1999
  • K982798Osteonics Anterior Cervical Compression Plating SystemOsteonics Corp. · 1999
  • K984585Osteonics +10 Unipolar Adaptor SleeveOsteonics Corp. · 1999

Recent decisions in HWC

The HWC category page

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https://510kreport.com/device/K983165 · printed Nov 6, 2026

Cite this page

510(k) Report. “K983165: Osteo 4.0MM 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/K983165

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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