510(k) · Cleared
ClearedNCB Polyaxial Locking Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer GmbH · HRS Plate, Fixation, Bone
Cleared on Aug 22, 2019 as substantially equivalent to K042695 (Zimmer GmbH, 2004) and 1 other predicate after a 24-day review. Its family tree reaches back 3 generations to 1996. 1 later device descends from it.
- Decided
- Aug 22, 2019
- Review
- 24 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K961413 (1996). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK961413 Synthes Anatomical Locking Plate SystemSynthes (Usa) · 1996
- 2 generations backK042695 NCB Plating SystemZimmer GmbH · 2004 · Recalled
- 1 generation backK081759 NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer…Zimmer GmbH · 2008 · Recalled
- This deviceK192021 NCB Polyaxial Locking Plate SystemZimmer GmbH · 2019
- Descendant · cites it directly · 0 of its ownK241754 NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate…Zimmer Switzerland Manufacturing GmbH · 2024
Most influential descendants
Showing 1 of 1 · See all- K241754NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable…Zimmer Switzerland Manufacturing GmbH · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K961413 | Synthes Anatomical Locking Plate System | Synthes (Usa) | 1996 | — |
| −2 | K042695 | NCB Plating System | Zimmer GmbH | 2004 | 1 |
| −1 | K081759 | NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer Universal… | Zimmer GmbH | 2008 | 2 |
| 0 (this device) | K192021 | NCB Polyaxial Locking Plate System | Zimmer GmbH | 2019 | — |
| +1 | K241754 | NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System… | Zimmer Switzerland Manufacturing GmbH | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K042695 | NCB Plating SystemSummary page 4…th or threaded metallic bone fixation fastener. Predicate Device: NCB® Plating System, manufactured by Zimmer GmbH, K042695, cleared October 29, 2004 NCB® Plating System, Proximal Hum… | 2004 |
| * | K081759 | NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer Universal Locking…Summary page 4…cleared October 29, 2004 NCB® Plating System, Proximal Humerus, manufactured by Zimmer GmbH, K081759, cleared October 16, 2008 Device Description: The NCB Polyaxial Locking Plate System is an extramedullary… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241754 | NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable… | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 8.2 years on median.
- 4 of the 7 ancestors have a recall of any class.
- Of its descendants, K241754 (Zimmer Switzerland Manufacturing GmbH, 2024) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K042695.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 NCB Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192021: NCB Polyaxial 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/K192021
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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