510(k) Report

510(k) · Cleared

Cleared

K4 Bone Screw System

K950704510(k) TraditionalCleared Jun 30, 1995135-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

Kinetikos Medical, Inc. · HWC Screw, Fixation, Bone

Cleared on Jun 30, 1995 after a 135-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 40 later devices descend from it.

Decided
Jun 30, 1995
Review
135 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
0

40 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2015: 1 descendant cleared2013: 1 descendant cleared2025: 3 descendants cleared2019: 3 descendants cleared2017: 3 descendants cleared2020: 5 descendants cleared2022: 8 descendants cleared2023: 7 descendants cleared2021: 1 descendant cleared2024: 3 descendants cleared2026: 4 descendants cleared1995200020052010201520202025
  1. This deviceK950704 K4 Bone Screw SystemKinetikos Medical, Inc. · 1995
  2. Descendant · cites it directly · 39 of its ownK120493 Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 2012 · Recalled
  3. Descendant · 2 generations on · 36 of its ownK123890 Acumed Cannulated Screw SystemAcumed, LLC · 2013 · Recalled
  4. Descendant · 3 generations on · 21 of its ownK190586 Monster® Screw SystemParagon 28, Inc. · 2019
  5. Descendant · 4 generations on · 9 of its ownK200398 AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020
  6. Descendant · 2 generations on · 9 of its ownK150693 PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015

Showing 5 of 40 descendants. See all descendants

Descendants cleared per year

2012: 12013: 12015: 12017: 32019: 32020: 52021: 12022: 82023: 72024: 32025: 32026: 4
2012high 8 (2022) · low 0 (2014)2026

Most influential descendants

Showing 5 of 40 · See all
  • K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 2012 · cites it directly39descendants
  • K123890Acumed Cannulated Screw SystemAcumed, LLC · 2013 · 2 generations on36descendants
  • K190586Monster® Screw SystemParagon 28, Inc. · 2019 · 3 generations on21descendants
  • K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020 · 4 generations on9descendants
  • K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015 · 2 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K950704K4 Bone Screw SystemKinetikos Medical, Inc.1995—
+1K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc.20121
+2K123890Acumed Cannulated Screw SystemAcumed, LLC20132
+3K190586Monster® Screw SystemParagon 28, Inc.2019—
+4K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH2020—
+2K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
201510
201730
201930
202050
202110
202280
202370
202430
202530
202640
FIG. 1 — Lineage of K950704, 1995–2026Source: 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? (40)

See all 40

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc.201239

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, K120493 (Instratek, Inc., 2012) has gone furthest, with 39 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 Kinetikos Medical, Inc.

19 FDA decisions under this applicant name. See the company

  • K061749Eclipse Total Ankle ImplantKinetikos Medical, Inc. · 2006
  • K061465Kmi Cement Restrictor ImplantKinetikos Medical, Inc. · 2006
  • K051611Mbaresorb ImplantKinetikos Medical, Inc. · 20053 recalls
  • K041461Kmi Distal Volar Radius Plate SystemKinetikos Medical, Inc. · 2004
  • K032806Katalyst Radial Head ImplantKinetikos Medical, Inc. · 2004

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https://510kreport.com/device/K950704 · printed Nov 6, 2026

Cite this page

510(k) Report. “K950704: K4 Bone 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/K950704

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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