510(k) · Cleared
Recalled · Class II · 2019Zimmer Periarticular Locking Plate 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 May 19, 2011 as substantially equivalent to K040593 (Zimmer, Inc., 2004) and 5 other predicates after a 35-day review. Its family tree reaches back 5 generations to 1996. 3 later devices descend from it. It has been recalled 4 times.
- Decided
- May 19, 2011
- Review
- 35 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 4
- Predicates
- 6
Its longest line of descent runs back 5 generations to K962616 (1996). 13 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 4 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 3 generations backK040593 Periarticular Locking Plates and Screws, 2358, 2359 SeriesZimmer, Inc. · 2004 · Recalled
- 2 generations backK042598 Periarticular Locking Plates and Screws, 2357 and 2359 SeriesZimmer, Inc. · 2004 · Recalled
- 1 generation backK050121 Zimmer Periarticular Locking Plate System, Model 2357 & 2359Zimmer, Inc. · 2005
- This deviceK111039 Zimmer Periarticular Locking Plate SystemZimmer, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK130810 Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK160633 G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK141734 Zimmer Periarticular Locking SystemZimmer, Inc. · 2014 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K130810Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc. · 2013 · cites it directly1descendant
- K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc. · 2016 · 2 generations on0descendants
- K141734Zimmer Periarticular Locking SystemZimmer, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −4 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −3 | K040593 | Periarticular Locking Plates and Screws, 2358, 2359 Series | Zimmer, Inc. | 2004 | 2 |
| −2 | K042598 | Periarticular Locking Plates and Screws, 2357 and 2359 Series | Zimmer, Inc. | 2004 | 1 |
| −1 | K050121 | Zimmer Periarticular Locking Plate System, Model 2357 & 2359 | Zimmer, Inc. | 2005 | — |
| 0 (this device) | K111039 | Zimmer Periarticular Locking Plate System | Zimmer, Inc. | 2011 | — |
| +1 | K130810 | Zimmer Motionloc Screw for Periarticular Locking Plate System | Zimmer, Inc. | 2013 | — |
| +2 | K160633 | G3(TM) Active Plate (R) Small Fragment System | Genesis Fracture Care, Inc. | 2016 | — |
| +1 | K141734 | Zimmer Periarticular Locking System | Zimmer, Inc. | 2014 | 3 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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? (6)
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…Smooth or threaded metallic bone fixation fastener - 21 CFR 888.3040 Predicate Devices: Zimmner Periarticular Locking Plate System - K040593 (cleared 4/12/2004), K042598 (cleared 10/29/2004), K043227 (cleared 12/10/2004), K0… | 2004 |
| * | K042598 | Periarticular Locking Plates and Screws, 2357 and 2359 SeriesSummary page 1…astener - 21 CFR 888.3040 Predicate Devices: Zimmner Periarticular Locking Plate System - K040593 (cleared 4/12/2004), K042598 (cleared 10/29/2004), K043227 (cleared 12/10/2004), K043560 (cleared 1/21/2005), K… | 2004 |
| * | K043227 | Periarticular Locking Plates, 2358 SeriesSummary page 1…dicate Devices: Zimmner Periarticular Locking Plate System - K040593 (cleared 4/12/2004), K042598 (cleared 10/29/2004), K043227 (cleared 12/10/2004), K043560 (cleared 1/21/2005), K050121 (cleared 1/31/2005) and K051098… | 2004 |
| * | K043560 | Periarticular Locking Plates and Screws, Series 2358 and 2359Summary page 1…riarticular Locking Plate System - K040593 (cleared 4/12/2004), K042598 (cleared 10/29/2004), K043227 (cleared 12/10/2004), K043560 (cleared 1/21/2005), K050121 (cleared 1/31/2005) and K051098 (cleared 7/7/2005) D… | 2005 |
| * | K050121 | Zimmer Periarticular Locking Plate System, Model 2357 & 2359Summary page 1…(cleared 4/12/2004), K042598 (cleared 10/29/2004), K043227 (cleared 12/10/2004), K043560 (cleared 1/21/2005), K050121 (cleared 1/31/2005) and K051098 (cleared 7/7/2005) Device Description: The Zimmer Periarticular Lockin… | 2005 |
| * | K051098 | Periarticular Locking Plates and Screws, Model 2358 SeriesSummary page 1…, K042598 (cleared 10/29/2004), K043227 (cleared 12/10/2004), K043560 (cleared 1/21/2005), K050121 (cleared 1/31/2005) and K051098 (cleared 7/7/2005) Device Description: The Zimmer Periarticular Locking Plate System is a plate… | 2005 |
What descends from it? (3)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2019 | Class II | Z-0311-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| Oct 10, 2019 | Class II | Z-0309-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| 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-0316-2020 | 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 15 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K130810 (Zimmer, Inc., 2013) has gone furthest, with 1 descendant 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. 2011, 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 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, and
* Malunions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111039 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111039: Zimmer Periarticular Locking Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111039
Report an extraction error
Are you the manufacturer?
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