510(k) · Cleared
Recalled · Class II · 2023Zimmer Periarticular Locking System
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 Aug 13, 2014 as substantially equivalent to K042598 (Zimmer, Inc., 2004) and 2 other predicates after a 47-day review. Its family tree reaches back 7 generations to 1996. It has been recalled 3 times.
- Decided
- Aug 13, 2014
- Review
- 47 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 7 generations to K962616 (1996). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 6 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 5 generations backK040593 Periarticular Locking Plates and Screws, 2358, 2359 SeriesZimmer, Inc. · 2004 · Recalled
- 4 generations backK042598 Periarticular Locking Plates and Screws, 2357 and 2359 SeriesZimmer, Inc. · 2004 · Recalled
- 3 generations backK050121 Zimmer Periarticular Locking Plate System, Model 2357 & 2359Zimmer, Inc. · 2005
- 2 generations backK070906 Modificaton to: Zimmer Periarticular Locking Plates and ScrewsZimmer, Inc. · 2007 · Recalled
- 1 generation backK082078 Zimmer Periarticular Locking Plate System: Distal Humeral and…Zimmer, Inc. · 2008 · Recalled
- This deviceK141734 Zimmer Periarticular Locking SystemZimmer, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −6 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −5 | K040593 | Periarticular Locking Plates and Screws, 2358, 2359 Series | Zimmer, Inc. | 2004 | 2 |
| −4 | K042598 | Periarticular Locking Plates and Screws, 2357 and 2359 Series | Zimmer, Inc. | 2004 | 1 |
| −3 | 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 |
| −1 | K082078 | Zimmer Periarticular Locking Plate System: Distal Humeral and Proximal Ulna… | Zimmer, Inc. | 2008 | 7 |
| 0 (this device) | K141734 | Zimmer Periarticular Locking System | Zimmer, Inc. | 2014 | — |
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 | 2 | 0 |
| 2005 | 2 | 0 |
| 2011 | 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? (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 |
|---|---|---|---|
| * | K042598 | Periarticular Locking Plates and Screws, 2357 and 2359 SeriesSummary page 4…888.3040) Classification Panel: Orthopedics/87, Product codes HRS, HWC Predicate Device(s): Zimmer Periarticular Locking Plate System (K042598, K082078, K111039) Purpose and Device This submission covers minor design modifications and Description: line ex… | 2004 |
| * | K082078 | Zimmer Periarticular Locking Plate System: Distal Humeral and Proximal Ulna PlatesSummary page 4…040) Classification Panel: Orthopedics/87, Product codes HRS, HWC Predicate Device(s): Zimmer Periarticular Locking Plate System (K042598, K082078, K111039) Purpose and Device This submission covers minor design modifications and Description: line extensions… | 2008 |
| * | K111039 | Zimmer Periarticular Locking Plate SystemSummary page 4…ssification Panel: Orthopedics/87, Product codes HRS, HWC Predicate Device(s): Zimmer Periarticular Locking Plate System (K042598, K082078, K111039) Purpose and Device This submission covers minor design modifications and Description: line extensions of the Zi… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 27, 2023 | Class II | Z-2254-2023 | Process control | Thread form issue of the locking holes in that the locking screws would not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock. |
| Oct 10, 2019 | Class II | Z-0310-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| Oct 10, 2019 | Class II | Z-0317-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 6 of the 16 ancestors have a recall of any class.
- 7 other devices also cite its predicate K042598.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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 Zimmer 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/K141734 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141734: Zimmer Periarticular Locking System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141734
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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