510(k) Report

510(k) · Cleared

Cleared

Periarticular Locking Plates and Screws, Model 2358 Series

K051098510(k) TraditionalCleared Jul 7, 200569-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

Zimmer, Inc. · HWC Screw, Fixation, Bone

Cleared on Jul 7, 2005 as substantially equivalent to K040593 (Zimmer, Inc., 2004) after a 69-day review. Its family tree reaches back 3 generations to 1996. 13 later devices descend from it.

Decided
Jul 7, 2005
Review
69 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K962616 (1996). 5 ancestors in all. 13 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1996: 1 other ancestor2011: 1 descendant cleared2012: 1 descendant cleared2016: 2 descendants cleared2014: 1 descendant cleared2013: 2 descendants cleared2018: 2 descendants cleared2021: 1 descendant cleared2017: 1 descendant cleared2025: 1 descendant cleared2020: 1 descendant clearedK962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998K040593 · Periarticular Locking Plates and Screws, 2358, 2359 Series · Zimmer, Inc. · 2004 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 7 descendants3 generations forward: 3 descendants K040593 · Periarticular Locking Plates and Screws, 2358, 2359 Series · Zimmer, Inc. · 2004 · recalledK982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998K962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 19960
  1. Root · 3 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 2 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 1 generation backK040593 Periarticular Locking Plates and Screws, 2358, 2359 SeriesZimmer, Inc. · 2004 · Recalled
  4. This deviceK051098 Periarticular Locking Plates and Screws, Model 2358 SeriesZimmer, Inc. · 2005
  5. Descendant · cites it directly · 6 of its ownK121601 Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma…Synthes USA · 2012
  6. Descendant · cites it directly · 3 of its ownK111039 Zimmer Periarticular Locking Plate SystemZimmer, Inc. · 2011 · Recalled
  7. Descendant · 2 generations on · 2 of its ownK171320 ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION…Meril Healthcare Pvt., Ltd. · 2018
  8. Descendant · cites it directly · 1 of its ownK161058 Cannulated ScrewMiami Device Solutions, LLC · 2016
  9. Descendant · 2 generations on · 1 of its ownK130810 Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc. · 2013

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2011: 12012: 12013: 22014: 12016: 22017: 12018: 22020: 12021: 12025: 1
2011high 2 (2013) · low 0 (2015)2026

Most influential descendants

Showing 5 of 13 · See all
  • K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA · 2012 · cites it directly6descendants
  • K111039Zimmer Periarticular Locking Plate SystemZimmer, Inc. · 2011 · cites it directly3descendants
  • K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd. · 2018 · 2 generations on2descendants
  • K161058Cannulated ScrewMiami Device Solutions, LLC · 2016 · cites it directly1descendant
  • K130810Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc. · 2013 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−2K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−1K040593Periarticular Locking Plates and Screws, 2358, 2359 SeriesZimmer, Inc.20042
0 (this device)K051098Periarticular Locking Plates and Screws, Model 2358 SeriesZimmer, Inc.2005—
+1K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal…Synthes USA2012—
+1K111039Zimmer Periarticular Locking Plate SystemZimmer, Inc.20114
+2K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws…Meril Healthcare Pvt., Ltd.2018—
+1K161058Cannulated ScrewMiami Device Solutions, LLC2016—
+2K130810Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201210
201320
201410
201620
201710
201820
202010
202110
202510
FIG. 1 — Lineage of K051098, 1996–2025Source: 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
*K040593Periarticular Locking Plates and Screws, 2358, 2359 Series
Summary page 1
…Preamcndment Device Zinizner Periarticular Locking Plate System, K040593, cleared April 12, 2004 Device Description: The Zimmer Periarticular Locking Plate System is a…
Zimmer, Inc.20042
*—Zimmer ECTI® Internal Fracture Fixation System
Named without a submission number
—

Also cleared against K040593: 13 other devices →

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126
K111039Zimmer Periarticular Locking Plate SystemZimmer, Inc.20113
K161058Cannulated ScrewMiami Device Solutions, LLC20161

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 9 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
  • 2 of the 5 ancestors have a recall of any class.
  • Of its descendants, K121601 (Synthes USA, 2012) has gone furthest, with 6 descendants of its own.
  • 13 other devices also cite its predicate K040593.

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 Periarticular Locking Plate System is indicated for temporary internal fixation and

stabilization of osteotomies and fractures, including:

* Comminuted fractures

* Supracondylar fractures

* Intra-articular and extra-articular condylar fractures

* Fractures in osteopenic bone

* Nonunions

* Malunions

Indications for use as stated in the FDA summary.

Also cleared against K040593

13 other devices cite the same predicate.

  • K161058Cannulated ScrewMiami Device Solutions, LLC · 2016
  • K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc. · 2015
  • K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc. · 2014
  • K133246Zimmer Distal Radius Plating SystemZimmer, Inc. · 2013
  • K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA · 2012
  • K111039Zimmer Periarticular Locking Plate SystemZimmer, Inc. · 20114 recalls

More from Zimmer, Inc.

524 FDA decisions under this applicant name. See the company

  • P060037/S100NexGen® LPS-Flex/LPS Mobile Bearing Knee SystemZimmer, Inc. · 2026
  • P060037/S099NexGen LPS-Flex Mobile and LPS-Mobile Bearing Knee SystemZimmer, Inc. · 2026
  • K262955OsseoFit Stemless Shoulder SystemZimmer, Inc. · 2026
  • P060037/S097Creep Pressure Test Update for the Nexgen LPS Bearing KneeZimmer, Inc. · 2026
  • P060037/S098Nexgen LPS Femoral and Tibial Knee componentsZimmer, Inc. · 2026

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/K051098 · printed Nov 5, 2026

Cite this page

510(k) Report. “K051098: Periarticular Locking Plates and Screws, Model 2358 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051098

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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