510(k) Report

510(k) · Cleared

Cleared

NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate

K241754510(k) TraditionalCleared Aug 15, 202458-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Zimmer Switzerland Manufacturing GmbH · HRS Plate, Fixation, Bone

Cleared on Aug 15, 2024 as substantially equivalent to K192217 (Zimmer GmbH, 2019) and 7 other predicates after a 58-day review. Its family tree reaches back 6 generations to 1998.

Decided
Aug 15, 2024
Review
58 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
8

Its longest line of descent runs back 6 generations to K981372 (1998). 32 ancestors in all, the oldest K953777 (1996). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2019: 2 other ancestors2012: 1 other ancestor2008: 1 other ancestor2006: 2 other ancestors2004: 2 other ancestors2009: 1 other ancestor2003: 2 other ancestors2001: 2 other ancestors2000: 6 other ancestors1996: 2 other ancestors1999: 3 other ancestors1997: 1 other ancestor1998: 1 other ancestorK981372 · Synthes 3.0 MM PC-Fix System · Synthes (Usa) · 1998K991407 · Synthes Locking Calcaneal Plates · Synthes (Usa) · 1999K033669 · Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) · Smith & Nephew, Inc. · 2003 · recalledK082807 · Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications · Synthes (Usa) · 2008K100111 · NCB Periprosthetic Femur Polyaxial Locking Plate System · Zimmer, Inc. · 2010 · recalledK113718 · NCB Straight Narrow Shaft Plates · Zimmer GmbH · 2012 · recalled1995200020052010201520202025
Other ancestors, by generation 1 generation back: 6 other ancestors2 generations back: 8 other ancestors3 generations back: 6 other ancestors4 generations back: 4 other ancestors5 generations back: 2 other ancestors K113718 · NCB Straight Narrow Shaft Plates · Zimmer GmbH · 2012 · recalledK100111 · NCB Periprosthetic Femur Polyaxial Locking Plate System · Zimmer, Inc. · 2010 · recalledK082807 · Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications · Synthes (Usa) · 2008K033669 · Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) · Smith & Nephew, Inc. · 2003 · recalledK991407 · Synthes Locking Calcaneal Plates · Synthes (Usa) · 1999K981372 · Synthes 3.0 MM PC-Fix System · Synthes (Usa) · 1998−50
  1. Root · 6 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
  2. 5 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
  3. 4 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
  4. 3 generations backK082807 Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with…Synthes (Usa) · 2008
  5. 2 generations backK100111 NCB Periprosthetic Femur Polyaxial Locking Plate SystemZimmer, Inc. · 2010 · Recalled
  6. 1 generation backK113718 NCB Straight Narrow Shaft PlatesZimmer GmbH · 2012 · Recalled
  7. This deviceK241754 NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate…Zimmer Switzerland Manufacturing GmbH · 2024
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K981372Synthes 3.0 MM PC-Fix SystemSynthes (Usa)1998—
−5K991407Synthes Locking Calcaneal PlatesSynthes (Usa)1999—
−4K033669Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws)Smith & Nephew, Inc.20031
−3K082807Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded…Synthes (Usa)2008—
−2K100111NCB Periprosthetic Femur Polyaxial Locking Plate SystemZimmer, Inc.20102
−1K113718NCB Straight Narrow Shaft PlatesZimmer GmbH20121
0 (this device)K241754NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System…Zimmer Switzerland Manufacturing GmbH2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199710
199810
199930
200060
200120
200320
200420
200620
200810
200910
201210
201920
FIG. 1 — Lineage of K241754, 1998–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (8)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K192217NCB Plating System Distal Femur and Proximal Tibia
Summary page 5
…3030 Product Code(s) HRS, HWC | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K192217 NCB Plating System Distal Femur and Proximal Tibia HRS K192021 NCB Polyaxial Locking Plate System HRS K081759 NCB Polyaxial Locki…
Zimmer GmbH2019—
*K192021NCB Polyaxial Locking Plate System
Summary page 5
…ices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K192217 NCB Plating System Distal Femur and Proximal Tibia HRS K192021 NCB Polyaxial Locking Plate System HRS K081759 NCB Polyaxial Locking Plate System, Proximal Humeral Plates HRS K061211 NCB Platin…
Zimmer GmbH2019—
*K081759NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer Universal Locking…
Summary page 5
…Trade Name (Primary Predicate is listed first) Product Code K192217 NCB Plating System Distal Femur and Proximal Tibia HRS K192021 NCB Polyaxial Locking Plate System HRS K081759 NCB Polyaxial Locking Plate System, Proximal Humeral Plates HRS K061211 NCB Plating System, Proximal Tibia Plates HRS K042695 NCB…
Zimmer GmbH20082
*K061211NCB Plating System, Proximal Tibia Plates
Summary page 5
…Plating System Distal Femur and Proximal Tibia HRS K192021 NCB Polyaxial Locking Plate System HRS K081759 NCB Polyaxial Locking Plate System, Proximal Humeral Plates HRS K061211 NCB Plating System, Proximal Tibia Plates HRS K042695 NCB Plating System HRS K120772 NCB PERIPROSTHETIC TROCHANTER PLATES AND SCR…
Zimmer GmbH20064
*K042695NCB Plating System
Summary page 5
…2021 NCB Polyaxial Locking Plate System HRS K081759 NCB Polyaxial Locking Plate System, Proximal Humeral Plates HRS K061211 NCB Plating System, Proximal Tibia Plates HRS K042695 NCB Plating System HRS K120772 NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREY| | HRS K100111 NCB Periprosthetic Femur Polyaxial L…
Zimmer GmbH20041
*K120772NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB Oplyaxial…
Summary page 5
…e System HRS K081759 NCB Polyaxial Locking Plate System, Proximal Humeral Plates HRS K061211 NCB Plating System, Proximal Tibia Plates HRS K042695 NCB Plating System HRS K120772 NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREY| | HRS K100111 NCB Periprosthetic Femur Polyaxial Locking Plate System HRS K113718…
Zimmer GmbH20122
*K100111NCB Periprosthetic Femur Polyaxial Locking Plate System
Summary page 5
…mal Humeral Plates HRS K061211 NCB Plating System, Proximal Tibia Plates HRS K042695 NCB Plating System HRS K120772 NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREY| | HRS K100111 NCB Periprosthetic Femur Polyaxial Locking Plate System HRS K113718 NCB Straight Narrow Shaft Plates HRS Device Description Summa…
Zimmer, Inc.20102
*K113718NCB Straight Narrow Shaft Plates
Summary page 5
…ates HRS K042695 NCB Plating System HRS K120772 NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREY| | HRS K100111 NCB Periprosthetic Femur Polyaxial Locking Plate System HRS K113718 NCB Straight Narrow Shaft Plates HRS Device Description Summary 21 CFR 807.92(a)(4) NCB® Polyaxial Locking Plate System The NCB…
Zimmer GmbH20121

Also cleared against K192217: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 26 years and passes through 5 companies; a new generation was cleared every 4.5 years on median.
  • 10 of the 32 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K192217.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

What is it indicated for?

NCB® Polyaxial Locking Plate System: The NCB Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of distal femoral (NCB DF), proximal humeral (NCB PH), and proximal tibial (NCB PT) fractures and osteotomies. NCB® Periprosthetic Femur Plate System: The NCB Periprosthetic Femur Plate System is indicated for temporary internal fixation and stabilization of femoral fractures and osteotomies, including periprosthetic…

Read the full statement (200 words)

NCB® Polyaxial Locking Plate System:

The NCB Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of distal femoral (NCB DF), proximal humeral (NCB PH), and proximal tibial (NCB PT) fractures and osteotomies.

NCB® Periprosthetic Femur Plate System:

The NCB Periprosthetic Femur Plate System is indicated for temporary internal fixation and stabilization of femoral fractures and osteotomies, including periprosthetic fractures.

If combined with the NCB Periprosthetic Trochanter Plate and Connection Screw, the NCB Periprosthetic Proximal Femur Plate is additionally indicated for temporary internal fixation and stabilization of greater trochanter fractures and osteotomies including re-attachment of the greater trochanter following fracture and osteotomy in total hip arthroplasty.

The NCB Periprosthetic Trochanter Plate and Connection Screw can only be used in combination with the NCB Periprosthetic Proximal Femur Plate.

NCB® Cable Button:

The NCB Cable Button for the NCB Polyaxial Locking Plate System in combination with the Zimmer Biomet NCB Polyaxial Locking Plate System and Cable-Ready System Cerclage Cables is indicated for temporary internal fixation of fractures and osteotomies.

NCB® Straight Narrow Shaft Plate

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K192217

2 other devices cite the same predicate.

  • K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH · 2023
  • K201259ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating SystemWrightmedicaltechnologyinc · 2021

More from Zimmer Switzerland Manufacturing GmbH

4 FDA decisions under this applicant name. See the company

  • K253749Affixus® Natural Nail® Proximal Humeral SystemZimmer Switzerland Manufacturing GmbH · 2025
  • K231114Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail SystemZimmer Switzerland Manufacturing GmbH · 2023
  • K212129Persona® Personalized Knee SystemZimmer Switzerland Manufacturing GmbH · 2021

Recent decisions in HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K241754 · printed Nov 6, 2026

Cite this page

510(k) Report. “K241754: NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241754

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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