510(k) · Cleared
ClearedNCB Plating System Distal Femur and Proximal Tibia
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 Sep 13, 2019 as substantially equivalent to K042695 (Zimmer GmbH, 2004) and 1 other predicate after a 29-day review. Its family tree reaches back 3 generations to 1996. 11 later devices descend from it.
- Decided
- Sep 13, 2019
- Review
- 29 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. 11 later devices descend from it, 3 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 backK061211 NCB Plating System, Proximal Tibia PlatesZimmer GmbH · 2006 · Recalled
- This deviceK192217 NCB Plating System Distal Femur and Proximal TibiaZimmer GmbH · 2019
- Descendant · cites it directly · 8 of its ownK222381 PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti…Stryker GmbH · 2023
- Descendant · 2 generations on · 4 of its ownK231262 Pangea Femur Plating System, Pangea Fibula Plating System, Pangea…Stryker GmbH · 2023
- Descendant · 3 generations on · 2 of its ownK250163 T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025
- Descendant · 3 generations on · 1 of its ownK253640 T2 Alpha Femur Retrograde Nailing System; Pangea Femur…Stryker GmbH · 2026
- Descendant · 2 generations on · 1 of its ownK233017 TM Plating SystemTyber Medical, LLC · 2023
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH · 2023 · cites it directly8descendants
- K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH · 2023 · 2 generations on4descendants
- K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025 · 3 generations on2descendants
- K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH · 2026 · 3 generations on1descendant
- K233017TM Plating SystemTyber Medical, LLC · 2023 · 2 generations on1descendant
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 | K061211 | NCB Plating System, Proximal Tibia Plates | Zimmer GmbH | 2006 | 4 |
| 0 (this device) | K192217 | NCB Plating System Distal Femur and Proximal Tibia | Zimmer GmbH | 2019 | — |
| +1 | K222381 | PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker… | Stryker GmbH | 2023 | — |
| +2 | K231262 | Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia… | Stryker GmbH | 2023 | — |
| +3 | K250163 | T2 Alpha Femur Retrograde Nailing System | Stryker GmbH | 2025 | — |
| +3 | K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System | Stryker GmbH | 2026 | — |
| +2 | K233017 | TM Plating System | Tyber Medical, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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…fastener Predicate Device: NCB® Plating System, Distal Femur, manufactured by Zimmer GmbH, K042695, cleared in October 2004 (primary predicate) NCB® Plating System, Proximal Tibia, manufactured… | 2004 |
| * | K061211 | NCB Plating System, Proximal Tibia PlatesSummary page 4…October 2004 (primary predicate) NCB® Plating System, Proximal Tibia, manufactured by Zimmer GmbH, K061211, cleared in June 2006 (line extension of K042695) Device Description: The NCB P… | 2006 |
What descends from it? (11)
See all 113 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222381 | PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System | 2023 | 8 |
| K241754 | NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable… | 2024 | 0 |
| K201259 | ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System | 2021 | 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.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K222381 (Stryker GmbH, 2023) has gone furthest, with 8 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 Plating 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/K192217 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192217: NCB Plating System Distal Femur and Proximal Tibia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192217
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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