510(k) · Cleared
Recalled · Class II · 2019NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer Universal Locking System, 3.5MM Tivanium TI-6AL-4V
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 Oct 16, 2008 as substantially equivalent to K042695 (Zimmer GmbH, 2004) and 1 other predicate after a 118-day review. Its family tree reaches back 2 generations to 1996. 21 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 16, 2008
- Review
- 118 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K961413 (1996). 6 ancestors in all. 21 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK961413 Synthes Anatomical Locking Plate SystemSynthes (Usa) · 1996
- 1 generation backK042695 NCB Plating SystemZimmer GmbH · 2004 · Recalled
- This deviceK081759 NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer…Zimmer GmbH · 2008
- Descendant · cites it directly · 10 of its ownK101696 Motionloc Screw for NCB Polyaxial Locking Plating SystemZimmer, Inc. · 2010
- Descendant · cites it directly · 7 of its ownK141493 Proximal Humerus Plating SystemMiami Device Solutions · 2015 · Recalled
- Descendant · 2 generations on · 5 of its ownK123918 Motionloc Screw for NCB Polyaxial Locking Plate SystemZimmer, Inc. · 2013
- Descendant · 2 generations on · 4 of its ownK161292 Distal Radius Plating SystemMiami Device Solutions, LLC · 2016
- Descendant · 2 generations on · 3 of its ownK142938 G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc. · 2014
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K101696Motionloc Screw for NCB Polyaxial Locking Plating SystemZimmer, Inc. · 2010 · cites it directly10descendants
- K141493Proximal Humerus Plating SystemMiami Device Solutions · 2015 · cites it directly7descendants
- K123918Motionloc Screw for NCB Polyaxial Locking Plate SystemZimmer, Inc. · 2013 · 2 generations on5descendants
- K161292Distal Radius Plating SystemMiami Device Solutions, LLC · 2016 · 2 generations on4descendants
- K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc. · 2014 · 2 generations on3descendants
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) | K081759 | NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer Universal… | Zimmer GmbH | 2008 | — |
| +1 | K101696 | Motionloc Screw for NCB Polyaxial Locking Plating System | Zimmer, Inc. | 2010 | — |
| +1 | K141493 | Proximal Humerus Plating System | Miami Device Solutions | 2015 | 1 |
| +2 | K123918 | Motionloc Screw for NCB Polyaxial Locking Plate System | Zimmer, Inc. | 2013 | — |
| +2 | K161292 | Distal Radius Plating System | Miami Device Solutions, LLC | 2016 | — |
| +2 | K142938 | G3 Active Plate Large Fragment System | Genesis Fracture Care, Inc. | 2014 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 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 1…crew, Fixation, Bone (21 CFR § 888.3040) Predicate Device: NCB Plating System, manufactured by Zimmer GmbH, K042695, cleared October 29, 2004 Zimmer® Universal Locking System, manufactured… | 2004 |
| * | K060710 | Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 ScrewsSummary page 1…5, cleared October 29, 2004 Zimmer® Universal Locking System, manufactured by Zimmer Inc., K06071 0, cleared April 26, 2006 Device Description: The NCB Polyaxial Locking Plate System is an… | 2006 |
What descends from it? (21)
See all 214 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 |
|---|---|---|---|---|
| Oct 10, 2019 | Class II | Z-0332-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| Sep 4, 2012 | Class II | Z-0246-2013 | 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 12 years and passes through 2 companies; a new generation was cleared every 8.2 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K101696 (Zimmer, Inc., 2010) has gone furthest, with 10 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. 2008, 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/K081759 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081759: NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer Universal Locking System, 3.5MM Tivanium TI-6AL-4V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081759
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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