510(k) · Cleared
Recalled · Class II · 2019NCB Periprosthetic Femur Polyaxial Locking Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · HRS Plate, Fixation, Bone
Cleared on Apr 12, 2010 as substantially equivalent to K082807 (Synthes (Usa), 2008) and 1 other predicate after an 88-day review. Its family tree reaches back 4 generations to 1998. 18 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 12, 2010
- Review
- 88 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 4 generations to K981372 (1998). 16 ancestors in all, the oldest K961413 (1996). 18 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 3 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 2 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- 1 generation backK082807 Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with…Synthes (Usa) · 2008
- This deviceK100111 NCB Periprosthetic Femur Polyaxial Locking Plate SystemZimmer, Inc. · 2010
- Descendant · cites it directly · 7 of its ownK113718 NCB Straight Narrow Shaft PlatesZimmer GmbH · 2012 · Recalled
- Descendant · cites it directly · 6 of its ownK120772 NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button…Zimmer GmbH · 2012 · Recalled
- Descendant · cites it directly · 5 of its ownK123918 Motionloc Screw for NCB Polyaxial Locking Plate SystemZimmer, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK161894 SurgTech Trauma SystemSurgtech, Inc. · 2017
- Descendant · 2 generations on · 2 of its ownK242939 ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K113718NCB Straight Narrow Shaft PlatesZimmer GmbH · 2012 · cites it directly7descendants
- K120772NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB Oplyaxial…Zimmer GmbH · 2012 · cites it directly6descendants
- K123918Motionloc Screw for NCB Polyaxial Locking Plate SystemZimmer, Inc. · 2013 · cites it directly5descendants
- K161894SurgTech Trauma SystemSurgtech, Inc. · 2017 · cites it directly3descendants
- K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −3 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −2 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| −1 | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded… | Synthes (Usa) | 2008 | — |
| 0 (this device) | K100111 | NCB Periprosthetic Femur Polyaxial Locking Plate System | Zimmer, Inc. | 2010 | — |
| +1 | K113718 | NCB Straight Narrow Shaft Plates | Zimmer GmbH | 2012 | 1 |
| +1 | K120772 | NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB… | Zimmer GmbH | 2012 | 2 |
| +1 | K123918 | Motionloc Screw for NCB Polyaxial Locking Plate System | Zimmer, Inc. | 2013 | — |
| +1 | K161894 | SurgTech Trauma System | Surgtech, Inc. | 2017 | — |
| +2 | K242939 | ARTFX Trauma Bone Plate and Screw System | Artfx Medical | 2024 | — |
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 |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSummary page 1…cking Compression Plate (LCP) System with Expa nded Indications, manufactured by Synthes, K082807, cleared January 13, 2009, and NCR® Plating System, K042695, cleared October… | 2008 |
| * | K042695 | NCB Plating SystemSummary page 1…ons, manufactured by Synthes, K082807, cleared January 13, 2009, and NCR® Plating System, K042695, cleared October 29, 2004. Device Description: The NCB (Non-Contact… | 2004 |
What descends from it? (18)
See all 185 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113718 | NCB Straight Narrow Shaft Plates | 2012 | 7 |
| K120772 | NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB Oplyaxial… | 2012 | 6 |
| K123918 | Motionloc Screw for NCB Polyaxial Locking Plate System | 2013 | 5 |
| K161894 | SurgTech Trauma System | 2017 | 3 |
| 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2019 | Class II | Z-0304-2020 | Packaging change control | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| Oct 10, 2019 | Class II | Z-0329-2020 | 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 12 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- 4 of the 16 ancestors have a recall of any class.
- Of its descendants, K113718 (Zimmer GmbH, 2012) has gone furthest, with 7 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. 2010, 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 NCR Periprosthetic Femur Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, including:
* Periprosthetic fractures
* Comminuted fractures
* Supracondylar fractures
* Fractures in osteopenic bone
* Nonunions
* Malunions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100111 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100111: NCB Periprosthetic Femur 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/K100111
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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