510(k) Report

510(k) · Cleared

Cleared

Precimed Cannulated Screw System

K050754510(k) TraditionalCleared May 18, 200556-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

Precimed, Inc. · HWC Screw, Fixation, Bone

Cleared on May 18, 2005 after a 56-day review. The FDA summary names its predicate without a number. 73 later devices descend from it.

Decided
May 18, 2005
Review
56 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
0

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

Descendants, by year cleared 2008: 2 descendants cleared2006: 1 descendant cleared2014: 3 descendants cleared2007: 2 descendants cleared2009: 3 descendants cleared2011: 2 descendants cleared2019: 5 descendants cleared2012: 1 descendant cleared2010: 2 descendants cleared2017: 6 descendants cleared2025: 9 descendants cleared2022: 4 descendants cleared2020: 6 descendants cleared2026: 6 descendants cleared2016: 1 descendant cleared2023: 5 descendants cleared2015: 1 descendant cleared2018: 3 descendants cleared2024: 10 descendants cleared2021: 1 descendant cleared20052010201520202025
  1. This deviceK050754 Precimed Cannulated Screw SystemPrecimed, Inc. · 2005
  2. Descendant · cites it directly · 66 of its ownK073344 Orthopediatrics Plating SystemOrthopediatrics, LLC · 2008
  3. Descendant · 2 generations on · 65 of its ownK081407 Orthopediatrics Pediplates SystemOrthoPediatrics Corp. · 2008
  4. Descendant · 2 generations on · 60 of its ownK083286 Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp. · 2009 · Recalled
  5. Descendant · 3 generations on · 28 of its ownK120689 Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC · 2012
  6. Descendant · 2 generations on · 15 of its ownK090666 PediplatesOrthoPediatrics Corp. · 2009

Showing 5 of 73 descendants. See all descendants

Descendants cleared per year

2006: 12007: 22008: 22009: 32010: 22011: 22012: 12014: 32015: 12016: 12017: 62018: 32019: 52020: 62021: 12022: 42023: 52024: 102025: 92026: 6
2006high 10 (2024) · low 0 (2013)2026

Most influential descendants

Showing 5 of 73 · See all
  • K073344Orthopediatrics Plating SystemOrthopediatrics, LLC · 2008 · cites it directly66descendants
  • K081407Orthopediatrics Pediplates SystemOrthoPediatrics Corp. · 2008 · 2 generations on65descendants
  • K083286Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp. · 2009 · 2 generations on60descendants
  • K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC · 2012 · 3 generations on28descendants
  • K090666PediplatesOrthoPediatrics Corp. · 2009 · 2 generations on15descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K050754Precimed Cannulated Screw SystemPrecimed, Inc.2005—
+1K073344Orthopediatrics Plating SystemOrthopediatrics, LLC2008—
+2K081407Orthopediatrics Pediplates SystemOrthoPediatrics Corp.2008—
+2K083286Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp.20095
+3K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC2012—
+2K090666PediplatesOrthoPediatrics Corp.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200720
200820
200930
201020
201120
201210
201430
201510
201610
201760
201830
201950
202060
202110
202240
202350
2024100
202590
202660
FIG. 1 — Lineage of K050754, 2005–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
*—Cannulated Screw System (S &N Richards)
Named without a submission number
—
*—Cannulated Screw System (Synthes)
Named without a submission number
—

What descends from it? (73)

See all 73

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

NumberDeviceApplicantDecidedDescendants
K073344Orthopediatrics Plating SystemOrthopediatrics, LLC200866
K061620Ifs Cannulated Bone ScrewInternal Fixation Systems, Inc.20065

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, K073344 (Orthopediatrics, LLC, 2008) has gone furthest, with 66 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 Precimed Cannulated Screw System is indicated for use in the treatment of bone fractures, such as fractures of the tarsals and metatarsals, and for metatarsal and phalangeal osteotomies and arthrodeses.

Indications for use as stated in the FDA summary.

More from Precimed, Inc.

2 FDA decisions under this applicant name. See the company

  • K023851Precimed Hip Screw SystemPrecimed, Inc. · 2003

Recent decisions in HWC

The HWC category page

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https://510kreport.com/device/K050754 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050754: Precimed 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/K050754

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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