510(k) · Cleared
Recalled · Class II · 2015Periarticular Locking Plates and Screws, 2358, 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 Apr 12, 2004 as substantially equivalent to K012114 (Synthes (Usa), 2001) and 1 other predicate after a 35-day review. Its family tree reaches back 2 generations to 1996. 162 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 12, 2004
- Review
- 35 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K962616 (1996). 4 ancestors in all. 162 later devices descend from it, 14 citing it directly.
- Root · 2 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 1 generation backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- This deviceK040593 Periarticular Locking Plates and Screws, 2358, 2359 SeriesZimmer, Inc. · 2004
- Descendant · cites it directly · 80 of its ownK100271 Vari AX Distal Radius Line Extensions of XXL PlatesHowmedica Osteonics Corp. · 2010
- Descendant · 2 generations on · 56 of its ownK112455 Aiming Blocks for Variax Distal Radius PlatesHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2011
- Descendant · 3 generations on · 40 of its ownK113760 Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012
- Descendant · cites it directly · 31 of its ownK042598 Periarticular Locking Plates and Screws, 2357 and 2359 SeriesZimmer, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 27 of its ownK050121 Zimmer Periarticular Locking Plate System, Model 2357 & 2359Zimmer, Inc. · 2005
Showing 5 of 162 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 162 · See all- K100271Vari AX Distal Radius Line Extensions of XXL PlatesHowmedica Osteonics Corp. · 2010 · cites it directly80descendants
- K112455Aiming Blocks for Variax Distal Radius PlatesHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2011 · 2 generations on56descendants
- K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012 · 3 generations on40descendants
- K042598Periarticular Locking Plates and Screws, 2357 and 2359 SeriesZimmer, Inc. · 2004 · cites it directly31descendants
- K050121Zimmer Periarticular Locking Plate System, Model 2357 & 2359Zimmer, Inc. · 2005 · 2 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −1 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| 0 (this device) | K040593 | Periarticular Locking Plates and Screws, 2358, 2359 Series | Zimmer, Inc. | 2004 | — |
| +1 | K100271 | Vari AX Distal Radius Line Extensions of XXL Plates | Howmedica Osteonics Corp. | 2010 | — |
| +2 | K112455 | Aiming Blocks for Variax Distal Radius Plates | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2011 | — |
| +3 | K113760 | Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2012 | — |
| +1 | K042598 | Periarticular Locking Plates and Screws, 2357 and 2359 Series | Zimmer, Inc. | 2004 | 1 |
| +2 | K050121 | Zimmer Periarticular Locking Plate System, Model 2357 & 2359 | Zimmer, Inc. | 2005 | — |
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 |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 10 | 0 |
| 2014 | 11 | 0 |
| 2015 | 6 | 0 |
| 2016 | 4 | 0 |
| 2017 | 12 | 0 |
| 2018 | 11 | 0 |
| 2019 | 8 | 0 |
| 2020 | 10 | 0 |
| 2021 | 7 | 0 |
| 2022 | 10 | 0 |
| 2023 | 10 | 0 |
| 2024 | 14 | 0 |
| 2025 | 14 | 0 |
| 2026 | 14 | 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? (3)
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 |
|---|---|---|---|
| * | K012114 | Synthes Locking Distal Radius Plating SystemSummary page 1…Preamendment Device Synthes Locking Distal Radius Plating System, K012114, cleared 9-28-01 Synthes Distal Radius Plate System, K982732,… | 2001 |
| * | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS)Summary page 1…ting System, K012114, cleared 9-28-01 Synthes Distal Radius Plate System, K982732, cleared 10-8-98 Device Description: The Zimmer Peri… | 1998 |
| * | — | Zimmer ECT® Internal Fracture Fixation System Named without a submission number |
What descends from it? (162)
See all 16214 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100271 | Vari AX Distal Radius Line Extensions of XXL Plates | 2010 | 80 |
| K042598 | Periarticular Locking Plates and Screws, 2357 and 2359 Series | 2004 | 31 |
| K063672 | Fibula Plate Prolock with Angular Stability | 2007 | 25 |
| K080184 | Distal Humeral Plates with Angular Stability | 2008 | 15 |
| K051098 | Periarticular Locking Plates and Screws, Model 2358 Series | 2005 | 13 |
| K043560 | Periarticular Locking Plates and Screws, Series 2358 and 2359 | 2005 | 13 |
| K043227 | Periarticular Locking Plates, 2358 Series | 2004 | 13 |
| K060969 | Polyax Locked Plating System | 2006 | 10 |
| K121601 | Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia Plate | 2012 | 6 |
| K142938 | G3 Active Plate Large Fragment System | 2014 | 3 |
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… |
| Jun 10, 2014 | Class II | Z-2131-2014 | Device Design | A complaint was received in which it was reported that an 8-hole plate from lot 62276042 had an enlarged hole that is unable to lock the screw, which resulted in the screw head pulling through plate hole. |
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 5.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K100271 (Howmedica Osteonics Corp., 2010) has gone furthest, with 80 descendants of its own.
- 15 other devices also cite its predicate K012114.
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/K040593 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040593: Periarticular Locking Plates and Screws, 2358, 2359 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040593
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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