510(k) · Cleared
Recalled · Class II · 2019NCB Plating System, Proximal Tibia Plates
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 Jun 14, 2006 as substantially equivalent to K042695 (Zimmer GmbH, 2004) and 2 other predicates after a 44-day review. Its family tree reaches back 2 generations to 1996. 25 later devices descend from it. It has been recalled 4 times.
- Decided
- Jun 14, 2006
- Review
- 44 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 2 generations to K961413 (1996). 6 ancestors in all. 25 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK961413 Synthes Anatomical Locking Plate SystemSynthes (Usa) · 1996
- 1 generation backK042695 NCB Plating SystemZimmer GmbH · 2004 · Recalled
- This deviceK061211 NCB Plating System, Proximal Tibia PlatesZimmer GmbH · 2006
- Descendant · cites it directly · 11 of its ownK192217 NCB Plating System Distal Femur and Proximal TibiaZimmer GmbH · 2019
- Descendant · cites it directly · 10 of its ownK101696 Motionloc Screw for NCB Polyaxial Locking Plating SystemZimmer, Inc. · 2010
- Descendant · 2 generations on · 8 of its ownK222381 PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti…Stryker GmbH · 2023
- Descendant · 2 generations on · 5 of its ownK123918 Motionloc Screw for NCB Polyaxial Locking Plate SystemZimmer, Inc. · 2013
- Descendant · 3 generations on · 4 of its ownK231262 Pangea Femur Plating System, Pangea Fibula Plating System, Pangea…Stryker GmbH · 2023
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K192217NCB Plating System Distal Femur and Proximal TibiaZimmer GmbH · 2019 · cites it directly11descendants
- K101696Motionloc Screw for NCB Polyaxial Locking Plating SystemZimmer, Inc. · 2010 · cites it directly10descendants
- K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH · 2023 · 2 generations on8descendants
- K123918Motionloc Screw for NCB Polyaxial Locking Plate SystemZimmer, Inc. · 2013 · 2 generations on5descendants
- K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH · 2023 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961413 | Synthes Anatomical Locking Plate System | Synthes (Usa) | 1996 | — |
| −1 | K042695 | NCB Plating System | Zimmer GmbH | 2004 | 1 |
| 0 (this device) | K061211 | NCB Plating System, Proximal Tibia Plates | Zimmer GmbH | 2006 | — |
| +1 | K192217 | NCB Plating System Distal Femur and Proximal Tibia | Zimmer GmbH | 2019 | — |
| +1 | K101696 | Motionloc Screw for NCB Polyaxial Locking Plating System | Zimmer, Inc. | 2010 | — |
| +2 | K222381 | PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker… | Stryker GmbH | 2023 | — |
| +2 | K123918 | Motionloc Screw for NCB Polyaxial Locking Plate System | Zimmer, Inc. | 2013 | — |
| +3 | K231262 | Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia… | Stryker GmbH | 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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K042695 | NCB Plating SystemSummary page 1…372-4605 April 28, 2006 NCB® Plating System Plate, Fixation, Bone Screw, Fixation, Bone 21 CFR § 888.3030, 3040 Zimmer NCB® Plating System, Humerus and Femur Plates (K042695, cleared October 29, 2004). Synthes 4.5mm Titanium LCP Proximal Tibia Plating System (K023802, cleared January 28, 2003). Synthe… | 2004 |
| * | K023802 | Synthes 4.5 MM Titanium LCP Proximal Tibia Plating SystemSummary page 1…CFR § 888.3030, 3040 Zimmer NCB® Plating System, Humerus and Femur Plates (K042695, cleared October 29, 2004). Synthes 4.5mm Titanium LCP Proximal Tibia Plating System (K023802, cleared January 28, 2003). Synthes 3.5mm Titanium LCP Proximal Tibia Plating System (K030597, cleared March 20, 2003). The NCB… | 2003 |
| * | K030597 | Synthes 3.5MM Titanium LCP Proximal Tibia PlatesSummary page 1…tober 29, 2004). Synthes 4.5mm Titanium LCP Proximal Tibia Plating System (K023802, cleared January 28, 2003). Synthes 3.5mm Titanium LCP Proximal Tibia Plating System (K030597, cleared March 20, 2003). The NCB Plating System is an extramedullary internal fixation plate system to be used for proximal tib… | 2003 |
What descends from it? (25)
See all 255 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192217 | NCB Plating System Distal Femur and Proximal Tibia | 2019 | 11 |
| K101696 | Motionloc Screw for NCB Polyaxial Locking Plating System | 2010 | 10 |
| K241754 | NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable… | 2024 | 0 |
| K151708 | RECON system - Compression Screws | 2016 | 0 |
| K151701 | Tenodesis screw system | 2016 | 0 |
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-0303-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| Sep 4, 2012 | Class II | Z-0243-2013 | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product… |
| Sep 4, 2012 | Class II | Z-0244-2013 | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product… |
| Sep 4, 2012 | Class II | Z-0245-2013 | Error in labeling | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 8.2 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K192217 (Zimmer GmbH, 2019) has gone furthest, with 11 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.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K061211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061211: NCB Plating System, Proximal Tibia Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061211
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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