510(k) Report

510(k) · Cleared

Cleared

Zimmer Motionloc Screw for Periarticular Locking Plate System

K130810510(k) TraditionalCleared Sep 19, 2013178-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 19, 2013 as substantially equivalent to K042598 (Zimmer, Inc., 2004) and 6 other predicates after a 178-day review. Its family tree reaches back 9 generations to 1996. 1 later device descends from it.

Decided
Sep 19, 2013
Review
178 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
7

Its longest line of descent runs back 9 generations to K962616 (1996). 55 ancestors in all, the oldest K890939 (1989). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2013: 1 other ancestor2011: 1 other ancestor2010: 2 other ancestors2005: 3 other ancestors2004: 9 other ancestors2012: 1 other ancestor2008: 2 other ancestors2006: 2 other ancestors2003: 3 other ancestors2000: 7 other ancestors2001: 6 other ancestors1999: 2 other ancestors1998: 2 other ancestors1996: 2 other ancestors1995: 1 other ancestor1991: 1 other ancestor1989: 1 other ancestor2016: 1 descendant clearedK962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998×2: 2 generations cleared close together, K023007 (2002), K030198 (2003) K032705 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003×2: 2 generations cleared close together, K050932 (2005), K051735 (2005) K061352 · Peri-Loc Periarticular Locked Plating System for the Upper Extremity · Smith & Nephew, Inc. · 2006K092015 · Peri-Loc Periarticular Locked Plating System · Smith & Nephew, Inc. · 2009 · recalled1990200020102020
  1. Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 5 generations between
  3. 3 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  4. 2 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
  5. 1 generation backK092015 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2009 · Recalled
  6. This deviceK130810 Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc. · 2013
  7. Descendant · cites it directly · 0 of its ownK160633 G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc. · 2016
Show all 9 generations
  1. Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 8 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 7 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 6 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 5 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 4 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 3 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 2 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
  9. 1 generation backK092015 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2009 · Recalled
  10. This deviceK130810 Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc. · 2013

Most influential descendants

Showing 1 of 1 · See all
  • K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−8K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−7K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−6K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−5K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−4K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−3K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−2K061352Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc.2006—
−1K092015Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.20091
0 (this device)K130810Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc.2013—
+1K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199110
199510
199620
199820
199920
200070
200160
200330
200490
200530
200620
200820
201020
201110
201210
201310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
FIG. 1 — Lineage of K130810, 1996–2016Source: 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
Get a 510(k) Report

What was it cleared against? (7)

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
*K042598Periarticular Locking Plates and Screws, 2357 and 2359 Series
Summary page 1
…(21 CFR § 888.3040, Product Code HWC) Predicate Device: Periarticular Locking Plates and Screws, 2357 and 2359 Series, K042598, cleared October 29, 2004; Periarticular Locking Plates, 2358 Series, K(043227,…
Zimmer, Inc.20041
*K043227Periarticular Locking Plates, 2358 Series
Summary page 1
…rews, 2357 and 2359 Series, K042598, cleared October 29, 2004; Periarticular Locking Plates, 2358 Series, K(043227, cleared December 10, 2004; Zimmier Periarticular Locking Plate Sys…
Zimmer, Inc.2004—
*K050121Zimmer Periarticular Locking Plate System, Model 2357 & 2359
Summary page 1
…ries, K(043227, cleared December 10, 2004; Zimmier Periarticular Locking Plate System, Model 2357 and 2359. K05012 1, cleared January 31, 2005; Zimmewr Periarticular Locking Plate Syst…
Zimmer, Inc.2005—
*K111039Zimmer Periarticular Locking Plate SystemZimmer, Inc.20114
*K092015Peri-Loc Periarticular Locked Plating System
Summary page 1
…Nephew PERI-LOC M Periarticular Locked Plating System Locking Bone Plates for Lower and Upper Extremity, K(092015, cleared July 30, 2009; MotionLoc' Screw for NCB® Polyaxial Locking Plate…
Smith & Nephew, Inc.20091
*K101696Motionloc Screw for NCB Polyaxial Locking Plating System
Summary page 1
…Upper Extremity, K(092015, cleared July 30, 2009; MotionLoc' Screw for NCB® Polyaxial Locking Plate System, K 10 1696, cleared September 10, 2010; Zhniner MotionLoc" Screw for NCB® Polyaxial…
Zimmer, Inc.2010—
*K123918Motionloc Screw for NCB Polyaxial Locking Plate System
Summary page 1
…m, K 10 1696, cleared September 10, 2010; Zhniner MotionLoc" Screw for NCB® Polyaxial Locking Plate System, K 123918, cleared February 14. 2013 Device Description: The Zininer MotionLoc Screw for Periart…
Zimmer, Inc.2013—

Also cleared against K042598: 7 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.20160

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 17 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
  • 19 of the 55 ancestors have a recall of any class.
  • Of its descendants, K160633 (Genesis Fracture Care, Inc., 2016) has gone furthest, with 0 descendants of its own.
  • 7 other devices also cite its predicate K042598.

How does its category compare?

All HWC devices

HWC Screw, 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 · 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?

Zimmer MotionLoc Screws, when used with the Periarticular Locking Plate System are indicated for temporary internal fixation and stabilization of osteotomies and fractures of long bones, including:

* Comminuted fractures

* Supracondylar fractures

* Intra-articular and extra-articular condylar fractures

* Fractures in osteopenic bone

* Nonunions

* Malunions

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K130810: Zimmer Motionloc Screw for Periarticular 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/K130810

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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