510(k) Report

510(k) · Cleared

Cleared

Low Profile Plate and Screw System

K052614510(k) SpecialCleared Sep 28, 20055-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Arthrex, Inc. · HRS Plate, Fixation, Bone

Cleared on Sep 28, 2005 as substantially equivalent to K040907 (Arthrex, Inc., 2004) after a 5-day review. Its family tree reaches back 5 generations to 2000. 245 later devices descend from it.

Decided
Sep 28, 2005
Review
5 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K000684 (2000). 13 ancestors in all, the oldest K890939 (1989). 245 later devices descend from it, 13 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2000: 1 other ancestor1996: 1 other ancestor2001: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor1991: 1 other ancestor1989: 1 other ancestor2011: 5 descendants cleared2024: 25 descendants cleared2020: 20 descendants cleared2012: 3 descendants cleared2017: 25 descendants cleared2015: 16 descendants cleared2014: 10 descendants cleared2013: 8 descendants cleared2019: 13 descendants cleared2025: 24 descendants cleared2022: 15 descendants cleared2026: 34 descendants cleared2023: 21 descendants cleared2018: 8 descendants cleared2021: 16 descendants cleared2016: 2 descendants clearedK000684 · Small Fragment Dynamic Compression Locking (DCL) System · Synthes (Usa) · 2000 · recalled×2: 2 generations cleared close together, K011335 (2001), K012655 (2001) K021626 · Hallu Plates · New Deal, S.A. · 2002K040907 · Arthrex Small Fragment Plates and Screws · Arthrex, Inc. · 20041990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 3 other ancestors3 generations back: 5 other ancestors 1 generation forward: 13 descendants2 generations forward: 48 descendants3 generations forward: 71 descendants4 generations forward: 69 descendants5 generations forward: 28 descendants6 generations forward: 11 descendants7 generations forward: 3 descendants8 generations forward: 2 descendants K040907 · Arthrex Small Fragment Plates and Screws · Arthrex, Inc. · 2004K021626 · Hallu Plates · New Deal, S.A. · 2002K012655 · Congruent Bone Plate System · Acu Med, Inc. · 2001 · recalledK011335 · Synths One-Third Tubular DCL Plate · Synthes (Usa) · 2001 · recalledK000684 · Small Fragment Dynamic Compression Locking (DCL) System · Synthes (Usa) · 2000 · recalled−50+5
  1. Root · 5 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
  2. 4 generations backK011335 Synths One-Third Tubular DCL PlateSynthes (Usa) · 2001 · Recalled
  3. 3 generations backK012655 Congruent Bone Plate SystemAcu Med, Inc. · 2001 · Recalled
  4. 2 generations backK021626 Hallu PlatesNew Deal, S.A. · 2002
  5. 1 generation backK040907 Arthrex Small Fragment Plates and ScrewsArthrex, Inc. · 2004
  6. This deviceK052614 Low Profile Plate and Screw SystemArthrex, Inc. · 2005
  7. Descendant · cites it directly · 219 of its ownK103705 Low Profile ScrewsArthrex, Inc. · 2011
  8. Descendant · 2 generations on · 135 of its ownK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
  9. Descendant · 2 generations on · 91 of its ownK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
  10. Descendant · 2 generations on · 71 of its ownK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
  11. Descendant · 2 generations on · 58 of its ownK111678 Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · Recalled

Showing 5 of 245 descendants. See all descendants

Descendants cleared per year

2011: 52012: 32013: 82014: 102015: 162016: 22017: 252018: 82019: 132020: 202021: 162022: 152023: 212024: 252025: 242026: 34
2011high 34 (2026) · low 2 (2016)2026

Most influential descendants

Showing 5 of 245 · 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
−5K000684Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa)20001
−4K011335Synths One-Third Tubular DCL PlateSynthes (Usa)20012
−3K012655Congruent Bone Plate SystemAcu Med, Inc.200116
−2K021626Hallu PlatesNew Deal, S.A.2002—
−1K040907Arthrex Small Fragment Plates and ScrewsArthrex, Inc.2004—
0 (this device)K052614Low Profile Plate and Screw SystemArthrex, Inc.2005—
+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
198910
199110
199410
199510
199610
200010
200110
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201150
201230
201380
2014100
2015160
201620
2017250
201880
2019130
2020200
2021160
2022150
2023210
2024250
2025240
2026340
FIG. 1 — Lineage of K052614, 2000–2026Source: 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 HRS? 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 HRS device

  1. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 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? (1)

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
*K040907Arthrex Small Fragment Plates and Screws
Summary page 1
…issue Smooth or threaded metallic bone fixation fastener PREDICATE DEVICES: K040907 Arthrex Small Fragment Plates and Screws DEVICE DESCRIPTION AND INTENDED USE: The Arthrex Low Profile Plate and Screw System…
Arthrex, Inc.2004—

Also cleared against K040907: 6 other devices →

What descends from it? (245)

See all 245

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

NumberDeviceApplicantDecidedDescendants
K103705Low Profile ScrewsArthrex, Inc.2011219
K140397Paralock Plating System / Tuffnek ScrewParagon 28201431
K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH201324
K193639APTUS® Foot 2.8-3.5 SystemMedartis AG20209
K130510Arthrex Compression PlatesArthrex, Inc.20138
K110086Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc.20115
K170780ARIX Foot System (2.3/2.8)Jeil Medical Corporation20174
K143402Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20151
K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121
K111326Osteowedge Opening Wedge Bone Locking SystemGraham Medical Technologies, LLC20111

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 5 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
  • 5 of the 13 ancestors have a recall of any class.
  • Of its descendants, K103705 (Arthrex, Inc., 2011) has gone furthest, with 219 descendants of its own.
  • 6 other devices also cite its predicate K040907.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, 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
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

What is it indicated for?

The Arthrex Low Profile Plate and Screw System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle, foot, hand, and wrist, such as opening wedge osteotomies of Hallux Valgus.

Indications for use as stated in the FDA summary.

Also cleared against K040907

6 other devices cite the same predicate.

  • K143749Arthrex Distal Radius SystemArthrex, Inc. · 2015
  • K140617Pinit Small Bone Fusion SystemArthrosurface, Inc. · 2014
  • K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
  • K130510Arthrex Compression PlatesArthrex, Inc. · 2013
  • K052152B-Bop PlateNew Deal, S.A. · 2005
  • K051162Generos SB Small Bone Distraction ImplantOrthonetx, Inc. · 2005

More from Arthrex, Inc.

355 FDA decisions under this applicant name. See the company

  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K262618Arthrex Spine Compression FT ScrewArthrex, Inc. · 2026
  • K262451Arthrex DynaNite StaplesArthrex, Inc. · 2026
  • K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K260624Arthrex Radial Head Replacement SystemArthrex, Inc. · 2026

Recent decisions in HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K052614 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052614: Low Profile Plate and 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/K052614

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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