510(k) · Cleared
ClearedPeriarticular Locking Plates and Screws, Series 2358 and 2359
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 Jan 21, 2005 as substantially equivalent to K040593 (Zimmer, Inc., 2004) after a 25-day review. Its family tree reaches back 3 generations to 1996. 13 later devices descend from it.
- Decided
- Jan 21, 2005
- Review
- 25 days
- Class
- Class II
- Product code
- HRS
- 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.
- 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 deviceK043560 Periarticular Locking Plates and Screws, Series 2358 and 2359Zimmer, Inc. · 2005
- Descendant · cites it directly · 6 of its ownK121601 Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma…Synthes USA · 2012
- Descendant · cites it directly · 3 of its ownK111039 Zimmer Periarticular Locking Plate SystemZimmer, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 2 of its ownK171320 ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION…Meril Healthcare Pvt., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK161058 Cannulated ScrewMiami Device Solutions, LLC · 2016
- 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
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
| 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) | K043560 | Periarticular Locking Plates and Screws, Series 2358 and 2359 | Zimmer, Inc. | 2005 | — |
| +1 | K121601 | Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal… | Synthes USA | 2012 | — |
| +1 | K111039 | Zimmer Periarticular Locking Plate System | Zimmer, Inc. | 2011 | 4 |
| +2 | K171320 | ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws… | Meril Healthcare Pvt., Ltd. | 2018 | — |
| +1 | K161058 | Cannulated Screw | Miami Device Solutions, LLC | 2016 | — |
| +2 | K130810 | Zimmer Motionloc Screw for Periarticular Locking Plate System | Zimmer, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040593 | Periarticular Locking Plates and Screws, 2358, 2359 SeriesSummary page 1…: 21 CER § 888.3030,3040 Predicate Device: Zimmer Periarticular Locking Plate System, K040593, cleared April 12, 2004 Device Description: The Zimmer Periarticular Locking Plate System is a… | 2004 |
What descends from it? (13)
See all 133 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 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/K043560 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043560: Periarticular Locking Plates and Screws, Series 2358 and 2359.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043560
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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