510(k) · Cleared
Recalled · Class II · 2019NCB Straight Narrow Shaft 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 Jan 27, 2012 as substantially equivalent to K082807 (Synthes (Usa), 2008) and 1 other predicate after a 39-day review. Its family tree reaches back 5 generations to 1998. 7 later devices descend from it. It has been recalled once.
- Decided
- Jan 27, 2012
- Review
- 39 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K981372 (1998). 17 ancestors in all, the oldest K961413 (1996). 7 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 4 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 3 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- 2 generations backK082807 Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with…Synthes (Usa) · 2008
- 1 generation backK100111 NCB Periprosthetic Femur Polyaxial Locking Plate SystemZimmer, Inc. · 2010 · Recalled
- This deviceK113718 NCB Straight Narrow Shaft PlatesZimmer GmbH · 2012
- Descendant · cites it directly · 5 of its ownK123918 Motionloc Screw for NCB Polyaxial Locking Plate SystemZimmer, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK143002 Metallic Locking Bone Plate and Screw SystemChangzhou Dingjian Medical Appliance Co., Ltd. · 2015
- Descendant · 2 generations on · 1 of its ownK130810 Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK241754 NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate…Zimmer Switzerland Manufacturing GmbH · 2024
- Descendant · 3 generations on · 0 of its ownK190842 Comus Locking Plate systemsJiangsu Trauhui Medical Instrument Co., Ltd. · 2020
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K123918Motionloc Screw for NCB Polyaxial Locking Plate SystemZimmer, Inc. · 2013 · cites it directly5descendants
- K143002Metallic Locking Bone Plate and Screw SystemChangzhou Dingjian Medical Appliance Co., Ltd. · 2015 · 2 generations on1descendant
- K130810Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc. · 2013 · 2 generations on1descendant
- K241754NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable…Zimmer Switzerland Manufacturing GmbH · 2024 · cites it directly0descendants
- K190842Comus Locking Plate systemsJiangsu Trauhui Medical Instrument Co., Ltd. · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −4 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −3 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| −2 | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded… | Synthes (Usa) | 2008 | — |
| −1 | K100111 | NCB Periprosthetic Femur Polyaxial Locking Plate System | Zimmer, Inc. | 2010 | 2 |
| 0 (this device) | K113718 | NCB Straight Narrow Shaft Plates | Zimmer GmbH | 2012 | — |
| +1 | K123918 | Motionloc Screw for NCB Polyaxial Locking Plate System | Zimmer, Inc. | 2013 | — |
| +2 | K143002 | Metallic Locking Bone Plate and Screw System | Changzhou Dingjian Medical Appliance Co., Ltd. | 2015 | — |
| +2 | K130810 | Zimmer Motionloc Screw for Periarticular Locking Plate System | Zimmer, Inc. | 2013 | — |
| +1 | K241754 | NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System… | Zimmer Switzerland Manufacturing GmbH | 2024 | — |
| +3 | K190842 | Comus Locking Plate systems | Jiangsu Trauhui Medical Instrument Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 2 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSummary page 1…(21 CFR 888.3030) Predicate Devices: 4.5mm Locking Compression Plate (LCP) System with Expanded Indications, manufactured by Synthes, k<082807, cleared January 13, 2009, and NCB Periprosthetic Femur Polyaxial Locking Plate Sys… | 2008 |
| * | K100111 | NCB Periprosthetic Femur Polyaxial Locking Plate SystemSummary page 1…cleared January 13, 2009, and NCB Periprosthetic Femur Polyaxial Locking Plate System, mranufactured by Zimmer, K1001 11, cleared April 12, 2010. Device Description: The NCR Straight Narrow Shaft Plates are a line of polyax… | 2010 |
What descends from it? (7)
2 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-0331-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 5 of the 17 ancestors have a recall of any class.
- Of its descendants, K123918 (Zimmer, Inc., 2013) has gone furthest, with 5 descendants of its own.
- 42 other devices also cite its predicate K082807.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Straight Narrow Shaft Plate is indicated for temporary internal fixation and stabilization of humeral and tibial shaft fractures and osteotomies, including:
* Periprosthetic fractures
* Comnmnuted fractures
* Fractures in osteopenic bone
* Nonunions
* Malunions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113718 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113718: NCB Straight Narrow Shaft Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113718
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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