510(k) Report

510(k) · Cleared

Cleared

Motionloc Screw for NCB Polyaxial Locking Plating System

K101696510(k) TraditionalCleared Sep 10, 201086-day reviewClass II21 CFR 888.3040

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

Zimmer, Inc. · HWC Screw, Fixation, Bone

Cleared on Sep 10, 2010 as substantially equivalent to K042695 (Zimmer GmbH, 2004) and 2 other predicates after an 86-day review. Its family tree reaches back 3 generations to 1996. 10 later devices descend from it.

Decided
Sep 10, 2010
Review
86 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K961413 (1996). 10 ancestors in all. 10 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2006: 1 other ancestor2003: 2 other ancestors2001: 1 other ancestor2000: 2 other ancestors2014: 1 descendant cleared2013: 3 descendants cleared2011: 1 descendant cleared2015: 3 descendants cleared2016: 1 descendant cleared2020: 1 descendant clearedK961413 · Synthes Anatomical Locking Plate System · Synthes (Usa) · 1996K042695 · NCB Plating System · Zimmer GmbH · 2004 · recalledK061211 · NCB Plating System, Proximal Tibia Plates · Zimmer GmbH · 2006 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 5 other ancestors3 generations back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 4 descendants3 generations forward: 1 descendant K061211 · NCB Plating System, Proximal Tibia Plates · Zimmer GmbH · 2006 · recalledK042695 · NCB Plating System · Zimmer GmbH · 2004 · recalledK961413 · Synthes Anatomical Locking Plate System · Synthes (Usa) · 19960
  1. Root · 3 generations backK961413 Synthes Anatomical Locking Plate SystemSynthes (Usa) · 1996
  2. 2 generations backK042695 NCB Plating SystemZimmer GmbH · 2004 · Recalled
  3. 1 generation backK061211 NCB Plating System, Proximal Tibia PlatesZimmer GmbH · 2006 · Recalled
  4. This deviceK101696 Motionloc Screw for NCB Polyaxial Locking Plating SystemZimmer, Inc. · 2010
  5. Descendant · cites it directly · 5 of its ownK123918 Motionloc Screw for NCB Polyaxial Locking Plate SystemZimmer, Inc. · 2013
  6. Descendant · cites it directly · 3 of its ownK142938 G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc. · 2014
  7. Descendant · 2 generations on · 2 of its ownK150649 G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc. · 2015
  8. Descendant · 2 generations on · 1 of its ownK152242 G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc. · 2015
  9. Descendant · 2 generations on · 1 of its ownK143002 Metallic Locking Bone Plate and Screw SystemChangzhou Dingjian Medical Appliance Co., Ltd. · 2015

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2011: 12013: 32014: 12015: 32016: 12020: 1
2011high 3 (2013) · low 0 (2012)2026

Most influential descendants

Showing 5 of 10 · See all
  • K123918Motionloc Screw for NCB Polyaxial Locking Plate SystemZimmer, Inc. · 2013 · cites it directly5descendants
  • K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc. · 2014 · cites it directly3descendants
  • K150649G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc. · 2015 · 2 generations on2descendants
  • K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc. · 2015 · 2 generations on1descendant
  • K143002Metallic Locking Bone Plate and Screw SystemChangzhou Dingjian Medical Appliance Co., Ltd. · 2015 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K961413Synthes Anatomical Locking Plate SystemSynthes (Usa)1996—
−2K042695NCB Plating SystemZimmer GmbH20041
−1K061211NCB Plating System, Proximal Tibia PlatesZimmer GmbH20064
0 (this device)K101696Motionloc Screw for NCB Polyaxial Locking Plating SystemZimmer, Inc.2010—
+1K123918Motionloc Screw for NCB Polyaxial Locking Plate SystemZimmer, Inc.2013—
+1K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.2014—
+2K150649G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.2015—
+2K152242G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc.2015—
+2K143002Metallic Locking Bone Plate and Screw SystemChangzhou Dingjian Medical Appliance Co., Ltd.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200020
200110
200320
200610
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201330
201410
201530
201610
202010
FIG. 1 — Lineage of K101696, 1996–2020Source: 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 HWC? 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 HWC device

  1. #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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
*K042695NCB Plating System
Summary page 1
…Bone Screw Classification Name Screw, Fixation, Bone and Reference: 21 CFR § 888.3040 Predicate Device: NCB Plating System, K042695, cleared October 29, 2004; NCB Plating System, Proximal Tibial Plates,…
Zimmer GmbH20041
*K061211NCB Plating System, Proximal Tibia Plates
Summary page 1
…NCB Plating System, K042695, cleared October 29, 2004; NCB Plating System, Proximal Tibial Plates, K06121 1, cleared June 14, 2006; NOB Plating System, Proximal H-umeral Plates, K081759, cleared October 16,…
Zimmer GmbH20064
*K081759NCB Polyaxial Locking Plate System, Proximal Humeral Plates, Zimmer Universal Locking…
Summary page 1
…tem, Proximal Tibial Plates, K06121 1, cleared June 14, 2006; NOB Plating System, Proximal H-umeral Plates, K081759, cleared October 16, 2008. Device Description: The MotionLoc Screw for Polyaxial NCB L…
Zimmer GmbH20082

Also cleared against K042695: 9 other devices →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K123918Motionloc Screw for NCB Polyaxial Locking Plate SystemZimmer, Inc.20135
K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20143
K130810Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc.20131
K130731Stabiliz Fixation System - SPL Locking ScrewStabiliz Orthopaedics, LLC20130
K1105923.7MM/5.0MM Dynamic Locking ScrewSynthes USA20110

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 14 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
  • 5 of the 10 ancestors have a recall of any class.
  • Of its descendants, K123918 (Zimmer, Inc., 2013) has gone furthest, with 5 descendants of its own.
  • 9 other devices also cite its predicate K042695.

How does its category compare?

All HWC devices

HWC Screw, 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 · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

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.

Cite this page

510(k) Report. “K101696: Motionloc Screw for NCB Polyaxial Locking Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101696

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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