510(k) Report

510(k) · Cleared

Cleared

Cancellous Bone Screw

K864626510(k) TraditionalCleared Dec 15, 198620-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

Dow Corning Wright · HWC Screw, Fixation, Bone

Cleared on Dec 15, 1986 after a 20-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 17 later devices descend from it.

Decided
Dec 15, 1986
Review
20 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
0

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

Descendants, by year cleared 2017: 2 descendants cleared2018: 4 descendants cleared2024: 3 descendants cleared2022: 1 descendant cleared2021: 3 descendants cleared2019: 1 descendant cleared2026: 2 descendants cleared2023: 1 descendant cleared1990200020102020
  1. This deviceK864626 Cancellous Bone ScrewDow Corning Wright · 1986
  2. Descendant · cites it directly · 16 of its ownK170444 PROCOTYL® PRIME Acetabular Cup SystemMicroport Orthopedics, Inc. · 2017
  3. Descendant · 2 generations on · 10 of its ownK171181 PROCOTYL® PRIME E-CLASS™ XLPE LinerMicroport Orthopedics, Inc. · 2017
  4. Descendant · 3 generations on · 5 of its ownK180263 EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018
  5. Descendant · 4 generations on · 4 of its ownK203420 EcoFit® Hip SystemImplantcast GmbH · 2021
  6. Descendant · 2 generations on · 2 of its ownK180798 Prime Acetabular Cup SystemMicroport Orthopedics, Inc. · 2018

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2017: 22018: 42019: 12021: 32022: 12023: 12024: 32026: 2
2017high 4 (2018) · low 0 (2020)2026

Most influential descendants

Showing 5 of 17 · See all
  • K170444PROCOTYL® PRIME Acetabular Cup SystemMicroport Orthopedics, Inc. · 2017 · cites it directly16descendants
  • K171181PROCOTYL® PRIME E-CLASS™ XLPE LinerMicroport Orthopedics, Inc. · 2017 · 2 generations on10descendants
  • K180263EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018 · 3 generations on5descendants
  • K203420EcoFit® Hip SystemImplantcast GmbH · 2021 · 4 generations on4descendants
  • K180798Prime Acetabular Cup SystemMicroport Orthopedics, Inc. · 2018 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K864626Cancellous Bone ScrewDow Corning Wright1986—
+1K170444PROCOTYL® PRIME Acetabular Cup SystemMicroport Orthopedics, Inc.2017—
+2K171181PROCOTYL® PRIME E-CLASS™ XLPE LinerMicroport Orthopedics, Inc.2017—
+3K180263EcoFit Vit E Acetabular SystemImplantcast GmbH2018—
+4K203420EcoFit® Hip SystemImplantcast GmbH2021—
+2K180798Prime Acetabular Cup SystemMicroport Orthopedics, Inc.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201720
201840
201910
202130
202210
202310
202430
202620
FIG. 1 — Lineage of K864626, 1986–2026Source: 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), 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (17)

See all 17

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

NumberDeviceApplicantDecidedDescendants
K170444PROCOTYL® PRIME Acetabular Cup SystemMicroport Orthopedics, Inc.201716
K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo)20181

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, K170444 (Microport Orthopedics, Inc., 2017) has gone furthest, with 16 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—

More from Dow Corning Wright

75 FDA decisions under this applicant name. See the company

  • K932210Ortholoc Advantim Revision Femoral ComponentDow Corning Wright · 1994
  • K932911Ortholoc Advantim L.S. Tibial ComponentDow Corning Wright · 1994
  • K934354Lacey All Polyethylene Tibial ComponentDow Corning Wright · 1994
  • K932222SLT Femoral HeadDow Corning Wright · 1994
  • K932858Ortholoc Advantim Tibial Base ComponentDow Corning Wright · 1994

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The HWC category page

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https://510kreport.com/device/K864626 · printed Nov 5, 2026

Cite this page

510(k) Report. “K864626: Cancellous Bone Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K864626

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026