510(k) · Cleared
ClearedMotionloc Screw for NCB 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 Feb 14, 2013 as substantially equivalent to K101696 (Zimmer, Inc., 2010) and 3 other predicates after a 57-day review. Its family tree reaches back 6 generations to 1998. 5 later devices descend from it.
- Decided
- Feb 14, 2013
- Review
- 57 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K981372 (1998). 24 ancestors in all, the oldest K961413 (1996). 5 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 5 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 4 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- 3 generations backK082807 Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with…Synthes (Usa) · 2008
- 2 generations backK100111 NCB Periprosthetic Femur Polyaxial Locking Plate SystemZimmer, Inc. · 2010 · Recalled
- 1 generation backK113718 NCB Straight Narrow Shaft PlatesZimmer GmbH · 2012 · Recalled
- This deviceK123918 Motionloc Screw for NCB Polyaxial Locking Plate SystemZimmer, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK143002 Metallic Locking Bone Plate and Screw SystemChangzhou Dingjian Medical Appliance Co., Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK130810 Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK190842 Comus Locking Plate systemsJiangsu Trauhui Medical Instrument Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK160633 G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK130731 Stabiliz Fixation System - SPL Locking ScrewStabiliz Orthopaedics, LLC · 2013
Most influential descendants
Showing 5 of 5 · See all- K143002Metallic Locking Bone Plate and Screw SystemChangzhou Dingjian Medical Appliance Co., Ltd. · 2015 · cites it directly1descendant
- K130810Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc. · 2013 · cites it directly1descendant
- K190842Comus Locking Plate systemsJiangsu Trauhui Medical Instrument Co., Ltd. · 2020 · 2 generations on0descendants
- K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc. · 2016 · 2 generations on0descendants
- K130731Stabiliz Fixation System - SPL Locking ScrewStabiliz Orthopaedics, LLC · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −5 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −4 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| −3 | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded… | Synthes (Usa) | 2008 | — |
| −2 | K100111 | NCB Periprosthetic Femur Polyaxial Locking Plate System | Zimmer, Inc. | 2010 | 2 |
| −1 | K113718 | NCB Straight Narrow Shaft Plates | Zimmer GmbH | 2012 | 1 |
| 0 (this device) | K123918 | Motionloc Screw for NCB Polyaxial Locking Plate System | Zimmer, Inc. | 2013 | — |
| +1 | K143002 | Metallic Locking Bone Plate and Screw System | Changzhou Dingjian Medical Appliance Co., Ltd. | 2015 | — |
| +1 | K130810 | Zimmer Motionloc Screw for Periarticular Locking Plate System | Zimmer, Inc. | 2013 | — |
| +2 | K190842 | Comus Locking Plate systems | Jiangsu Trauhui Medical Instrument Co., Ltd. | 2020 | — |
| +2 | K160633 | G3(TM) Active Plate (R) Small Fragment System | Genesis Fracture Care, Inc. | 2016 | — |
| +1 | K130731 | Stabiliz Fixation System - SPL Locking Screw | Stabiliz Orthopaedics, LLC | 2013 | — |
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 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2015 | 1 | 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 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? (4)
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 |
|---|---|---|---|
| * | K101696 | Motionloc Screw for NCB Polyaxial Locking Plating SystemSummary page 1…redicate Devices: The predicate devices are: * Zimmer MotionLoc Screw For NCB Polyaxial Locking Plate System, K 101696, cleared September 10, 2010 * Zimmer NCB Periprosthetic Femur Polyaxial Locking Plate… | 2010 |
| * | K100111 | NCB Periprosthetic Femur Polyaxial Locking Plate System | 2010 |
| * | K113718 | NCB Straight Narrow Shaft PlatesSummary page 1…r Polyaxial Locking Plate System (KIOO0I111, cleared April 12, 20 10) a Zimmer NCB Straight Narrow Shaft Plates (KI 113718, cleared January 27, 2012) * Synthes 4.5mm Locking Compression Plate (LCP)… | 2012 |
| * | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSummary page 1…January 27, 2012) * Synthes 4.5mm Locking Compression Plate (LCP) with Extended Indications (K082807, cleared January 13, 2009) Purpose and Device This submission extends the indications of the existing MotionLoc Description… | 2008 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 9 of the 24 ancestors have a recall of any class.
- Of its descendants, K143002 (Changzhou Dingjian Medical Appliance Co., Ltd., 2015) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K101696.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
MotionLoc Screws, when used with the NOB Proximal Humeral or NOB Proximal Tibial plates, are indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, including: Comminiuted fractures Fractures in osteopenic bone Nonunions/Malunions MotionLoc Screws, when used with the NCB Distall Femoral plates, are indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones…
Read the full statement (153 words)
MotionLoc Screws, when used with the NOB Proximal Humeral or NOB Proximal Tibial plates, are indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, including:
Comminiuted fractures
Fractures in osteopenic bone
Nonunions/Malunions
MotionLoc Screws, when used with the NCB Distall Femoral plates, are indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones, including:
Comminuted fractures
Supracondylar fractures
Fractures in osteopenic bone
Nonunions/Malunions
MotionLoc Screws, when used with the NOB Straight Narrow Shaft plates, are indicated for temporary internal fixation and stabilization of humeral and tibial shaft fractures and osteotomies, including:
Periprosthetic fractures
Comminuted fractures
Fractures in osteopenic bone
Nonunions/Malunions
MotionLoc Screws, when used with the NOCB Periprosthetic Proximal Femur, Distal Femur or Curved Femur Shaft plates, are 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/K123918 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123918: Motionloc Screw for NCB 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/K123918
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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