510(k) · Cleared
Recalled · Class II · 2015Periarticular Locking Plates and Screws, 2357 and 2359 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · HRS Plate, Fixation, Bone
Cleared on Oct 29, 2004 as substantially equivalent to K040593 (Zimmer, Inc., 2004) and 2 other predicates after a 36-day review. Its family tree reaches back 3 generations to 1996. 31 later devices descend from it. It has been recalled once.
- Decided
- Oct 29, 2004
- Review
- 36 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K962616 (1996). 8 ancestors in all. 31 later devices descend from it, 8 citing it directly.
- Root · 3 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 2 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 1 generation backK040593 Periarticular Locking Plates and Screws, 2358, 2359 SeriesZimmer, Inc. · 2004 · Recalled
- This deviceK042598 Periarticular Locking Plates and Screws, 2357 and 2359 SeriesZimmer, Inc. · 2004
- Descendant · cites it directly · 27 of its ownK050121 Zimmer Periarticular Locking Plate System, Model 2357 & 2359Zimmer, Inc. · 2005
- Descendant · 2 generations on · 14 of its ownK070906 Modificaton to: Zimmer Periarticular Locking Plates and ScrewsZimmer, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 7 of its ownK111086 Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp. · 2011 · Recalled
- Descendant · cites it directly · 6 of its ownK121601 Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma…Synthes USA · 2012
- Descendant · 3 generations on · 4 of its ownK082078 Zimmer Periarticular Locking Plate System: Distal Humeral and…Zimmer, Inc. · 2008 · Recalled
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K050121Zimmer Periarticular Locking Plate System, Model 2357 & 2359Zimmer, Inc. · 2005 · cites it directly27descendants
- K070906Modificaton to: Zimmer Periarticular Locking Plates and ScrewsZimmer, Inc. · 2007 · 2 generations on14descendants
- K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp. · 2011 · 3 generations on7descendants
- K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA · 2012 · cites it directly6descendants
- K082078Zimmer Periarticular Locking Plate System: Distal Humeral and Proximal Ulna PlatesZimmer, Inc. · 2008 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −2 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −1 | K040593 | Periarticular Locking Plates and Screws, 2358, 2359 Series | Zimmer, Inc. | 2004 | 2 |
| 0 (this device) | K042598 | Periarticular Locking Plates and Screws, 2357 and 2359 Series | Zimmer, Inc. | 2004 | — |
| +1 | K050121 | Zimmer Periarticular Locking Plate System, Model 2357 & 2359 | Zimmer, Inc. | 2005 | — |
| +2 | K070906 | Modificaton to: Zimmer Periarticular Locking Plates and Screws | Zimmer, Inc. | 2007 | 21 |
| +3 | K111086 | Orthopediatrics Fracture and Osteotomy Bone Plate System | OrthoPediatrics Corp. | 2011 | 1 |
| +1 | K121601 | Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal… | Synthes USA | 2012 | — |
| +3 | K082078 | Zimmer Periarticular Locking Plate System: Distal Humeral and Proximal Ulna… | Zimmer, Inc. | 2008 | 7 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
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 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040593 | Periarticular Locking Plates and Screws, 2358, 2359 SeriesSummary page 1…2I (TR § 888.3030,31040 Predicate Devices: Zimmner®~ Periarticular Locking Plate System K040593, cleared April 12, 2004 Synthes Locking Condylar Plate (LCP) System -… | 2004 |
| * | K000066 | Synthes (Usa) Locking Condylar Plate (LCP) SystemSummary page 1…12, 2004 Synthes Locking Condylar Plate (LCP) System - 4.5mm LCP Condylar Plate, K000066, cleared March 15, 2000 Zitnmer®~ ECT®K I… | 2000 |
| * | K033805 | Synthes (Usa) 3.5 / 4.5 MM LCP Metaphyseal PlatesSummary page 1…eamendrnents Device Synthes LCP System - 3.5/4.5min LCP Metaphyseal Plate System, K033805, cleared February 20, 2004 Zinmmer®R Magn… | 2004 |
| * | — | Zimmer ECT Internal Fracture Fixation System Named without a submission number | |
| * | — | Zimmer Magna-Ex Cannulated Screw Fixation System Named without a submission number |
What descends from it? (31)
See all 318 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050121 | Zimmer Periarticular Locking Plate System, Model 2357 & 2359 | 2005 | 27 |
| K121601 | Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia Plate | 2012 | 6 |
| K111039 | Zimmer Periarticular Locking Plate System | 2011 | 3 |
| K161058 | Cannulated Screw | 2016 | 1 |
| K152242 | G3¿ Active Plate® Large Fragment System | 2015 | 1 |
| K130810 | Zimmer Motionloc Screw for Periarticular Locking Plate System | 2013 | 1 |
| K111447 | Zimmer Periarticular Screws | 2011 | 1 |
| K141734 | Zimmer Periarticular Locking System | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 9, 2015 | Class II | Z-0646-2016 | Labeling Change Control | Product on the package label did not match what was inside the package. The label was for part number 00-2359-058-35 (Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58mm Length) lot number 62918019 while the product inside… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K050121 (Zimmer, Inc., 2005) has gone furthest, with 27 descendants of its own.
- 13 other devices also cite its predicate K040593.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
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.
https://510kreport.com/device/K042598 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042598: Periarticular Locking Plates and Screws, 2357 and 2359 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042598
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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