510(k) Report

510(k) · Cleared

Cleared

Osteomed Extended 2.0/2.4CANNULATED Screw System

K062863510(k) TraditionalCleared Oct 31, 200636-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 LP · HWC Screw, Fixation, Bone

Cleared on Oct 31, 2006 as substantially equivalent to K010783 (Osteomed Corp., 2001) and 3 other predicates after a 36-day review. Its family tree reaches back 2 generations to 2002. 310 later devices descend from it.

Decided
Oct 31, 2006
Review
36 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K013888 (2002). 5 ancestors in all, the oldest K954330 (1995). 310 later devices descend from it, 8 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1996: 1 other ancestor1995: 1 other ancestor2014: 18 descendants cleared2015: 24 descendants cleared2013: 10 descendants cleared2011: 9 descendants cleared2009: 1 descendant cleared2012: 7 descendants cleared2010: 1 descendant cleared2017: 31 descendants cleared2024: 24 descendants cleared2020: 21 descendants cleared2019: 15 descendants cleared2025: 26 descendants cleared2018: 14 descendants cleared2016: 7 descendants cleared2021: 22 descendants cleared2026: 37 descendants cleared2022: 22 descendants cleared2023: 21 descendants clearedK013888 · Fixation (Steinmann) Pins · Miltex, Inc. · 2002K031050 · PCW Percutaneous Compression Wire · Millennium Medical Technologies, Inc. · 20031995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 8 descendants2 generations forward: 45 descendants3 generations forward: 92 descendants4 generations forward: 86 descendants5 generations forward: 48 descendants6 generations forward: 20 descendants7 generations forward: 7 descendants8 generations forward: 3 descendants9 generations forward: 1 descendant K031050 · PCW Percutaneous Compression Wire · Millennium Medical Technologies, Inc. · 2003K013888 · Fixation (Steinmann) Pins · Miltex, Inc. · 20020+5
  1. Root · 2 generations backK013888 Fixation (Steinmann) PinsMiltex, Inc. · 2002
  2. 1 generation backK031050 PCW Percutaneous Compression WireMillennium Medical Technologies, Inc. · 2003
  3. This deviceK062863 Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP · 2006
  4. Descendant · cites it directly · 219 of its ownK103705 Low Profile ScrewsArthrex, Inc. · 2011
  5. Descendant · 2 generations on · 135 of its ownK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
  6. Descendant · 2 generations on · 91 of its ownK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
  7. Descendant · 2 generations on · 71 of its ownK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
  8. Descendant · 2 generations on · 58 of its ownK111678 Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · Recalled

Showing 5 of 310 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12011: 92012: 72013: 102014: 182015: 242016: 72017: 312018: 142019: 152020: 212021: 222022: 222023: 212024: 242025: 262026: 37
2009high 37 (2026) · low 1 (2009)2026

Most influential descendants

Showing 5 of 310 · See all
  • K103705Low Profile ScrewsArthrex, Inc. · 2011 · cites it directly219descendants
  • K111253Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011 · 2 generations on135descendants
  • K112437Arthrex Fracture SystemArthrex, Inc. · 2011 · 2 generations on91descendants
  • K123241Arthrex Fracture PlatesArthrex, Inc. · 2013 · 2 generations on71descendants
  • K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · 2 generations on58descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K013888Fixation (Steinmann) PinsMiltex, Inc.2002—
−1K031050PCW Percutaneous Compression WireMillennium Medical Technologies, Inc.2003—
0 (this device)K062863Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP2006—
+1K103705Low Profile ScrewsArthrex, Inc.2011—
+2K111253Arthrex Distal Extremity Plate SystemArthrex, Inc.2011—
+2K112437Arthrex Fracture SystemArthrex, Inc.2011—
+2K123241Arthrex Fracture PlatesArthrex, Inc.2013—
+2K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited20121

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199610
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201190
201270
2013100
2014180
2015240
201670
2017310
2018140
2019150
2020210
2021220
2022220
2023210
2024240
2025260
2026370
FIG. 1 — Lineage of K062863, 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? (4)

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
*K0107832.0/2.4 Cannulated Screw System
Summary page 1
…s device is based on similarities in intended use, material, design and operational principle to the Osteomed Cannulated Screw Systems (K010783 and K954330), the BioPro Digital Compression Screw (K963433) and the Millennium Medical Technologies Percutaneou…
Osteomed Corp.2001—
*K954330Super Screw 3.5 MM
Summary page 1
…based on similarities in intended use, material, design and operational principle to the Osteomed Cannulated Screw Systems (K010783 and K954330), the BioPro Digital Compression Screw (K963433) and the Millennium Medical Technologies Percutaneous Compressio…
Osteomed Corp.1995—
*K963433Threaded Fixation Pin
Summary page 1
…design and operational principle to the Osteomed Cannulated Screw Systems (K010783 and K954330), the BioPro Digital Compression Screw (K963433) and the Millennium Medical Technologies Percutaneous Compression Wire (K031050).…
Orthopaedic Biosystems, Ltd.1996—
*K031050PCW Percutaneous Compression Wire
Summary page 1
…783 and K954330), the BioPro Digital Compression Screw (K963433) and the Millennium Medical Technologies Percutaneous Compression Wire (K031050). Due to the similarity of materials and design to both pre-enactment and post- enactment devi…
Millennium Medical Technologies, Inc.2003—

Also cleared against K010783: 3 other devices →

What descends from it? (310)

See all 310

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

NumberDeviceApplicantDecidedDescendants
K103705Low Profile ScrewsArthrex, Inc.2011219
K083912Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsTreu-Instrumente GmbH200948
K111536Metasurg Digifuse ImplantMetasurg201130
K151021OsteoMed Cannulated Screw SystemOsteomed Corp.201516
K130412Osteomed Extremifuse SystemOsteomed20134
K120015Osteomed Wrist Plating SystemOsteomed LP20122
K152527Integra DigiFuse Cannulated Intramedullary Fusion SystemAscension Orthopedics20151
K140283Osteomed Extremifuse SystemOsteomed20140

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 4 years and passes through 3 companies; a new generation was cleared every 3.3 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K103705 (Arthrex, Inc., 2011) has gone furthest, with 219 descendants of its own.
  • 3 other devices also cite its predicate K010783.

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 Osteomed Extended 2.0/2.4 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 as stated in the FDA summary.

Also cleared against K010783

3 other devices cite the same predicate.

  • K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 20121 recall
  • K101030Modification to HBS Headless Bone ScrewBiopro, Inc. · 20102 recalls
  • K051309Roi Fusion Rods & PlatesReiley Orthopaedics, Inc. · 20052 recalls

More from Osteomed LP

29 FDA decisions under this applicant name. See the company

  • K143338Argulated Locking PlatesOsteomed LP · 2015
  • K133691Extrimilock Ankle Plating SystemOsteomed LP · 2014
  • K131445Osteomed Extremilock Foot Plating SystemOsteomed LP · 2013
  • K123885Osteomed Smartflex Cranial Spring DistractorOsteomed LP · 2013
  • K123207Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemOsteomed LP · 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/K062863 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062863: Osteomed Extended 2.0/2.4CANNULATED 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/K062863

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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