510(k) · Cleared
ClearedMotionloc Screw for NCB Polyaxial Locking Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
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.
- Root · 3 generations backK961413 Synthes Anatomical Locking Plate SystemSynthes (Usa) · 1996
- 2 generations backK042695 NCB Plating SystemZimmer GmbH · 2004 · Recalled
- 1 generation backK061211 NCB Plating System, Proximal Tibia PlatesZimmer GmbH · 2006 · Recalled
- This deviceK101696 Motionloc Screw for NCB Polyaxial Locking Plating SystemZimmer, Inc. · 2010
- 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 ownK142938 G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK150649 G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK152242 G3¿ Active Plate® Large Fragment SystemGenesis Fracture Care, Inc. · 2015
- 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
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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K961413 | Synthes Anatomical Locking Plate System | Synthes (Usa) | 1996 | — |
| −2 | K042695 | NCB Plating System | Zimmer GmbH | 2004 | 1 |
| −1 | K061211 | NCB Plating System, Proximal Tibia Plates | Zimmer GmbH | 2006 | 4 |
| 0 (this device) | K101696 | Motionloc Screw for NCB Polyaxial Locking Plating System | Zimmer, Inc. | 2010 | — |
| +1 | K123918 | Motionloc Screw for NCB Polyaxial Locking Plate System | Zimmer, Inc. | 2013 | — |
| +1 | K142938 | G3 Active Plate Large Fragment System | Genesis Fracture Care, Inc. | 2014 | — |
| +2 | K150649 | G3 Active Plate Large Fragment System | Genesis Fracture Care, Inc. | 2015 | — |
| +2 | K152242 | G3¿ Active Plate® Large Fragment System | Genesis Fracture Care, Inc. | 2015 | — |
| +2 | K143002 | Metallic Locking Bone Plate and Screw System | Changzhou Dingjian Medical Appliance Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2020 | 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 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 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042695 | NCB Plating SystemSummary 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,… | 2004 |
| * | K061211 | NCB Plating System, Proximal Tibia PlatesSummary 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,… | 2006 |
| * | K081759 | NCB 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… | 2008 |
What descends from it? (10)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123918 | Motionloc Screw for NCB Polyaxial Locking Plate System | 2013 | 5 |
| K142938 | G3 Active Plate Large Fragment System | 2014 | 3 |
| K130810 | Zimmer Motionloc Screw for Periarticular Locking Plate System | 2013 | 1 |
| K130731 | Stabiliz Fixation System - SPL Locking Screw | 2013 | 0 |
| K110592 | 3.7MM/5.0MM Dynamic Locking Screw | 2011 | 0 |
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 devicesHWC 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
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
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.
https://510kreport.com/device/K101696 · printed Nov 6, 2026
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