510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

NCB Plating System

K042695510(k) TraditionalCleared Oct 29, 200429-day reviewClass II21 CFR 888.3030Recalls 1

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

Zimmer GmbH · HRS Plate, Fixation, Bone

Cleared on Oct 29, 2004 as substantially equivalent to K961413 (Synthes (Usa), 1996) and 2 other predicates after a 29-day review. Its family tree reaches back 1 generation to 1996. 68 later devices descend from it. It has been recalled once.

Decided
Oct 29, 2004
Review
29 days
Class
Class II
Product code
HRS
Recalls
1
Predicates
3

Its longest line of descent runs back 1 generation to K961413 (1996). 3 ancestors in all. 68 later devices descend from it, 10 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2000: 1 other ancestor2008: 1 descendant cleared2019: 2 descendants cleared2014: 2 descendants cleared2006: 1 descendant cleared2012: 3 descendants cleared2016: 6 descendants cleared2024: 7 descendants cleared2010: 2 descendants cleared2015: 4 descendants cleared2013: 3 descendants cleared2017: 6 descendants cleared2011: 1 descendant cleared2018: 5 descendants cleared2021: 4 descendants cleared2023: 7 descendants cleared2026: 6 descendants cleared2025: 4 descendants cleared2020: 3 descendants cleared2022: 1 descendant clearedK961413 · Synthes Anatomical Locking Plate System · Synthes (Usa) · 19961995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 10 descendants2 generations forward: 16 descendants3 generations forward: 17 descendants4 generations forward: 17 descendants5 generations forward: 4 descendants6 generations forward: 2 descendants7 generations forward: 2 descendants K961413 · Synthes Anatomical Locking Plate System · Synthes (Usa) · 19960+5
  1. Root · 1 generation backK961413 Synthes Anatomical Locking Plate SystemSynthes (Usa) · 1996
  2. This deviceK042695 NCB Plating SystemZimmer GmbH · 2004
  3. Descendant · cites it directly · 25 of its ownK061211 NCB Plating System, Proximal Tibia PlatesZimmer GmbH · 2006 · Recalled
  4. Descendant · cites it directly · 21 of its ownK081759 NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer…Zimmer GmbH · 2008 · Recalled
  5. Descendant · cites it directly · 20 of its ownK121672 Aft Proximal Humerus Fracture PlateShoulder Options, Inc. · 2012
  6. Descendant · cites it directly · 18 of its ownK100111 NCB Periprosthetic Femur Polyaxial Locking Plate SystemZimmer, Inc. · 2010 · Recalled
  7. Descendant · 2 generations on · 16 of its ownK133668 Aft Greater Tuberosity Fracture Plate, Left, Aft Greater Tuberosity…Shoulder Options, Inc. · 2014

Showing 5 of 68 descendants. See all descendants

Descendants cleared per year

2006: 12008: 12010: 22011: 12012: 32013: 32014: 22015: 42016: 62017: 62018: 52019: 22020: 32021: 42022: 12023: 72024: 72025: 42026: 6
2006high 7 (2023) · low 0 (2007)2026

Most influential descendants

Showing 5 of 68 · See all
  • K061211NCB Plating System, Proximal Tibia PlatesZimmer GmbH · 2006 · cites it directly25descendants
  • K081759NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer Universal Locking…Zimmer GmbH · 2008 · cites it directly21descendants
  • K121672Aft Proximal Humerus Fracture PlateShoulder Options, Inc. · 2012 · cites it directly20descendants
  • K100111NCB Periprosthetic Femur Polyaxial Locking Plate SystemZimmer, Inc. · 2010 · cites it directly18descendants
  • K133668Aft Greater Tuberosity Fracture Plate, Left, Aft Greater Tuberosity Fracture Plate…Shoulder Options, Inc. · 2014 · 2 generations on16descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K961413Synthes Anatomical Locking Plate SystemSynthes (Usa)1996—
0 (this device)K042695NCB Plating SystemZimmer GmbH2004—
+1K061211NCB Plating System, Proximal Tibia PlatesZimmer GmbH20064
+1K081759NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer Universal…Zimmer GmbH20082
+1K121672Aft Proximal Humerus Fracture PlateShoulder Options, Inc.2012—
+1K100111NCB Periprosthetic Femur Polyaxial Locking Plate SystemZimmer, Inc.20102
+2K133668Aft Greater Tuberosity Fracture Plate, Left, Aft Greater Tuberosity Fracture…Shoulder Options, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200810
201020
201110
201230
201330
201420
201540
201660
201760
201850
201920
202030
202140
202210
202370
202470
202540
202660
FIG. 1 — Lineage of K042695, 1996–2026Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K961413Synthes Anatomical Locking Plate System
Summary page 1
…21 CFR § 888.3030, 3040 Predicate Devices: Synthes Anatomical Locking Plate System (aka LISS), K961413, cleared 8-7-96 DePuy Orthopedics Pe.R.I. II Knee Fracture…
Synthes (Usa)1996—
*K003235PE.R.I. II Knee Fracture System
Summary page 1
…LISS), K961413, cleared 8-7-96 DePuy Orthopedics Pe.R.I. II Knee Fracture System, K003235, cleared 1-06-00 Synthes LCP Proximal Humerus Plate, K01 1815,…
DePuy Orthopaedics, Inc.2000—
*K011815Synthes LCP Proximal Humerus Plates
Summary page 1
…Knee Fracture System, K003235, cleared 1-06-00 Synthes LCP Proximal Humerus Plate, K01 1815, cleared 9-6-01. Device Description: The NCB Plating System is…
Synthes (Usa)2001—

Also cleared against K961413: 7 other devices →

What descends from it? (68)

See all 68

10 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K061211NCB Plating System, Proximal Tibia PlatesZimmer GmbH200625
K081759NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer Universal Locking…Zimmer GmbH200821
K121672Aft Proximal Humerus Fracture PlateShoulder Options, Inc.201220
K100111NCB Periprosthetic Femur Polyaxial Locking Plate SystemZimmer, Inc.201018
K192217NCB Plating System Distal Femur and Proximal TibiaZimmer GmbH201911
K101696Motionloc Screw for NCB Polyaxial Locking Plating SystemZimmer, Inc.201010
K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20143
K192021NCB Polyaxial Locking Plate SystemZimmer GmbH20191
K241754NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable…Zimmer Switzerland Manufacturing GmbH20240
K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 13, 2012Class IIZ-2187-2012Labeling mix-upsZimmer investigation following a complaint found one lot of NCB Polyaxial Locking Plate System NCB screws, 26mm, distributed in the United States contained incorrect 32 mm screws.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K061211 (Zimmer GmbH, 2006) has gone furthest, with 25 descendants of its own.
  • 7 other devices also cite its predicate K961413.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

The NCB Plating 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.

Also cleared against K961413

7 other devices cite the same predicate.

  • K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating SystemNebula Surgical Private Limited · 2019
  • K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2019
  • K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2018
  • K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A · 2012
  • K111891Synthes Brainlab Trauma Compatible InstrumentsSynthes (USA) Products, LLC · 2011
  • K1105923.7MM/5.0MM Dynamic Locking ScrewSynthes USA · 20112 recalls

More from Zimmer GmbH

43 FDA decisions under this applicant name. See the company

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  • K200814Affixus (R) Natural Nail (R) System Humeral NailZimmer GmbH · 2020
  • K200112Zimmer Hip Joint ReplacementZimmer GmbH · 20202 recalls
  • K193099Anatomical Shoulder SystemZimmer GmbH · 2020
  • K193050Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral StemZimmer GmbH · 2019

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/K042695 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042695: NCB Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042695

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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