510(k) · Cleared
Recalled · Class II · 2024Modificaton to: Zimmer Periarticular Locking Plates and Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · HWC Screw, Fixation, Bone
Cleared on May 1, 2007 as substantially equivalent to K050121 (Zimmer, Inc., 2005) after a 29-day review. Its family tree reaches back 5 generations to 1996. 14 later devices descend from it. It has been recalled 21 times.
- Decided
- May 1, 2007
- Review
- 29 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 21
- Predicates
- 1
Its longest line of descent runs back 5 generations to K962616 (1996). 10 ancestors in all. 14 later devices descend from it, 3 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 deviceK070906 Modificaton to: Zimmer Periarticular Locking Plates and ScrewsZimmer, Inc. · 2007
- Descendant · cites it directly · 7 of its ownK111086 Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp. · 2011 · Recalled
- Descendant · cites it directly · 4 of its ownK082078 Zimmer Periarticular Locking Plate System: Distal Humeral and…Zimmer, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 2 of its ownK192181 PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 1 of its ownK162307 OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp. · 2016
- Descendant · 2 generations on · 1 of its ownK140431 Pediloc Fragment SystemOrthoPediatrics Corp. · 2014
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
2008high 2 (2014) · low 0 (2009)2026
Most influential descendants
Showing 5 of 14 · See all- K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp. · 2011 · cites it directly7descendants
- K082078Zimmer Periarticular Locking Plate System: Distal Humeral and Proximal Ulna PlatesZimmer, Inc. · 2008 · cites it directly4descendants
- K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc. · 2019 · 2 generations on2descendants
- K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp. · 2016 · 2 generations on1descendant
- K140431Pediloc Fragment SystemOrthoPediatrics Corp. · 2014 · 2 generations on1descendant
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) | K070906 | Modificaton to: Zimmer Periarticular Locking Plates and Screws | Zimmer, Inc. | 2007 | — |
| +1 | K111086 | Orthopediatrics Fracture and Osteotomy Bone Plate System | OrthoPediatrics Corp. | 2011 | 1 |
| +1 | K082078 | Zimmer Periarticular Locking Plate System: Distal Humeral and Proximal Ulna… | Zimmer, Inc. | 2008 | 7 |
| +2 | K192181 | PRECICE Plating System | Nuvasive Specialized Orthopedics, Inc. | 2019 | 1 |
| +2 | K162307 | OrthoPediatrics Locking Proximal Femur System Cortical Screws | OrthoPediatrics Corp. | 2016 | — |
| +2 | K140431 | Pediloc Fragment System | OrthoPediatrics Corp. | 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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 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 |
|---|---|---|---|
| * | K050121 | Zimmer Periarticular Locking Plate System, Model 2357 & 2359Summary page 1…dicate Device: Plates Zimmer Periarticular Plates, manufactured by Zimmer Inc., K050121, cleared January 31, 2005 Screws 2.7mm Locking Screw, K05… | 2005 |
What descends from it? (14)
See all 143 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 |
|---|---|---|---|---|
| Mar 20, 2024 | Class II | Z-1713-2024 | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may 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, may result in delay in… |
| Mar 20, 2024 | Class II | Z-1725-2024 | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may 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, may result in delay in… |
| Mar 20, 2024 | Class II | Z-1709-2024 | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may 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, may result in delay in… |
| Mar 20, 2024 | Class II | Z-1715-2024 | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may 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, may result in delay in… |
| Mar 20, 2024 | Class II | Z-1719-2024 | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may 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, may result in delay in… |
| Mar 20, 2024 | Class II | Z-1716-2024 | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may 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, may result in delay in… |
| Mar 20, 2024 | Class II | Z-1728-2024 | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may 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, may result in delay in… |
| Mar 20, 2024 | Class II | Z-1720-2024 | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may 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, may result in delay in… |
| Mar 20, 2024 | Class II | Z-1723-2024 | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may 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, may result in delay in… |
| Mar 20, 2024 | Class II | Z-1726-2024 | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may 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, may result in delay in… |
| Mar 20, 2024 | Class II | Z-1727-2024 | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may 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, may result in delay in… |
| Mar 20, 2024 | Class II | Z-1729-2024 | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may 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, may result in delay in… |
| Mar 20, 2024 | Class II | Z-1722-2024 | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may 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, may result in delay in… |
| Mar 20, 2024 | Class II | Z-1724-2024 | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may 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, may result in delay in… |
| Mar 20, 2024 | Class II | Z-1718-2024 | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may 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, may result in delay in… |
| Mar 20, 2024 | Class II | Z-1711-2024 | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may 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, may result in delay in… |
| Mar 20, 2024 | Class II | Z-1714-2024 | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may 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, may result in delay in… |
| Mar 20, 2024 | Class II | Z-1717-2024 | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may 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, may result in delay in… |
| Mar 20, 2024 | Class II | Z-1721-2024 | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may 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, may result in delay in… |
| Mar 20, 2024 | Class II | Z-1710-2024 | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may 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, may result in delay in… |
| Mar 20, 2024 | Class II | Z-1712-2024 | Under Investigation by firm | Thread form issue for the locking holes in that the locking screws may 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, may result in delay in… |
The 5 latest of 21 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K111086 (OrthoPediatrics Corp., 2011) has gone furthest, with 7 descendants of its own.
- 4 other devices also cite its predicate K050121.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2007high 41 (2015) · low 15 (2025)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
2007high 167 (2022) · low 75 (2020)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
2007high 33 (2008) · low 0 (2023)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
2007high 5,463 (2019) · low 651 (2009)2025
MAUDE reports naming product code HWC, 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 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The Periarticular Locking Plate System is indicated for temporary internal fixation and
stabilization of osteotomies and fracture, 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/K070906 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070906: Modificaton to: Zimmer Periarticular Locking Plates and Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070906
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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