510(k) · Cleared
Recalled · Class II · 2019Zimmer Periarticular Plating 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 Feb 23, 2015 as substantially equivalent to K140508 (Zimmer, Inc., 2014) and 2 other predicates after a 34-day review. Its family tree reaches back 6 generations to 2000. It has been recalled 9 times.
- Decided
- Feb 23, 2015
- Review
- 34 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 9
- Predicates
- 3
Its longest line of descent runs back 6 generations to K000684 (2000). 15 ancestors in all, the oldest K874669 (1987). No later device cites it as a predicate yet.
- Root · 6 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 5 generations backK060710 Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835…Zimmer, Inc. · 2006 · Recalled
- 4 generations backK063303 Universal Locking System, 2.7MM Plates & ScrewsZimmer, Inc. · 2006 · Recalled
- 3 generations backK112885 Zimmer Plates and Screws System Screws OnlyZimmer, Inc. · 2011 · Recalled
- 2 generations backK140508 Zimmer Plates and Screws System (ZPS)- Non-Sterile Plates and ScrewsZimmer, Inc. · 2014
- 1 generation backK143066 Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions…Zimmer, Inc. · 2014
- This deviceK150121 Zimmer Periarticular Plating SystemZimmer, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −5 | K060710 | Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 Screws | Zimmer, Inc. | 2006 | 5 |
| −4 | K063303 | Universal Locking System, 2.7MM Plates & Screws | Zimmer, Inc. | 2006 | 4 |
| −3 | K112885 | Zimmer Plates and Screws System Screws Only | Zimmer, Inc. | 2011 | 15 |
| −2 | K140508 | Zimmer Plates and Screws System (ZPS)- Non-Sterile Plates and Screws | Zimmer, Inc. | 2014 | — |
| −1 | K143066 | Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions… | Zimmer, Inc. | 2014 | — |
| 0 (this device) | K150121 | Zimmer Periarticular Plating System | Zimmer, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K140508 | Zimmer Plates and Screws System (ZPS)- Non-Sterile Plates and ScrewsSummary page 4…d References: Appliances and Accessories, 21 CFR 888.3030 (HRS) Classification Panel: Orthopedics/87 Predicate Devices: Zimmer Plates and Screws System (K140508, K143066) Zimmer Universal Locking System (K063303) Purpose and Device The Zimmer Periarticular Pla… | 2014 |
| * | K143066 | Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile…Summary page 4…ces: Appliances and Accessories, 21 CFR 888.3030 (HRS) Classification Panel: Orthopedics/87 Predicate Devices: Zimmer Plates and Screws System (K140508, K143066) Zimmer Universal Locking System (K063303) Purpose and Device The Zimmer Periarticular Plating Syst… | 2014 |
| * | K063303 | Universal Locking System, 2.7MM Plates & ScrewsSummary page 4…assification Panel: Orthopedics/87 Predicate Devices: Zimmer Plates and Screws System (K140508, K143066) Zimmer Universal Locking System (K063303) Purpose and Device The Zimmer Periarticular Plating System consists of Description: temporary implants for the… | 2006 |
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 |
|---|---|---|---|---|
| Oct 10, 2019 | Class II | Z-0313-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| Oct 10, 2019 | Class II | Z-0314-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| Oct 10, 2019 | Class II | Z-0305-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| Oct 10, 2019 | Class II | Z-0307-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| Oct 10, 2019 | Class II | Z-0308-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| Oct 10, 2019 | Class II | Z-0315-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| Jan 11, 2016 | Class II | Z-1122-2016 | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. |
| Jan 11, 2016 | Class II | Z-1156-2016 | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. |
| Jan 11, 2016 | Class II | Z-1125-2016 | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. |
The 5 latest of 9 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 15 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- 6 of the 15 ancestors have a recall of any class.
- 3 other devices also cite its predicate K140508.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Periarticular Plating System plates are 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. Periarticular Plating System Small Distal Volar Radial Radius and Small Distal Volar Ulnar Radius plates are indicated for temporary internal fixation and…
Read the full statement (108 words)
Periarticular Plating System plates are 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.
Periarticular Plating System Small Distal Volar Radial Radius and Small Distal Volar Ulnar Radius plates are indicated for temporary internal fixation and stabilization of fractures and osteotomies of the volar aspect of the distal radius, including associated carpal fusions.
Periarticular Plating System Calcaneal plates are indicated for complex extra-articular and intra-articular fractures and osteotomies of the calcaneus.
Periarticular Plating System screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150121 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150121: Zimmer Periarticular Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150121
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