510(k) Report

510(k) · Cleared

Cleared

Loqteq Small Fragment Set Loqteq Cortical SCREW3.5, Small Head, T15, Self Tapping Loqteq Cortical Screw 3.5, T15, Self T

K113652510(k) TraditionalCleared Aug 30, 2012262-day reviewClass II21 CFR 888.3030

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

Aap Implantate AG · HRS Plate, Fixation, Bone

Cleared on Aug 30, 2012 as substantially equivalent to K000684 (Synthes (Usa), 2000) and 2 other predicates after a 262-day review. Its family tree reaches back 3 generations to 2000. 8 later devices descend from it.

Decided
Aug 30, 2012
Review
262 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K000684 (2000). 4 ancestors in all. 8 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2018: 1 descendant cleared2016: 2 descendants cleared2014: 1 descendant cleared2021: 2 descendants cleared2022: 1 descendant cleared2026: 1 descendant clearedK000684 · Small Fragment Dynamic Compression Locking (DCL) System · Synthes (Usa) · 2000 · recalledK060710 · Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 Screws · Zimmer, Inc. · 2006 · recalledK082527 · Zimmer Universal Locking System: 3.5 MM Locking Plates and Screws · Zimmer, Inc. · 2008 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 3 descendants K082527 · Zimmer Universal Locking System: 3.5 MM Locking Plates and Screws · Zimmer, Inc. · 2008 · recalledK060710 · Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 Screws · Zimmer, Inc. · 2006 · recalledK000684 · Small Fragment Dynamic Compression Locking (DCL) System · Synthes (Usa) · 2000 · recalled0
  1. Root · 3 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
  2. 2 generations backK060710 Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835…Zimmer, Inc. · 2006 · Recalled
  3. 1 generation backK082527 Zimmer Universal Locking System: 3.5 MM Locking Plates and ScrewsZimmer, Inc. · 2008 · Recalled
  4. This deviceK113652 Loqteq Small Fragment Set Loqteq Cortical SCREW3.5, Small Head, T15…Aap Implantate AG · 2012
  5. Descendant · cites it directly · 3 of its ownK173641 Activ AnkleNewclip Technics · 2018
  6. Descendant · 2 generations on · 0 of its ownK261511 Xpert AnkleNewclip Technics · 2026
  7. Descendant · 2 generations on · 0 of its ownK221395 Footmotion Plating SystemNewclip Technics · 2022
  8. Descendant · cites it directly · 0 of its ownK202803 Activmotion S DTONewclip Technics · 2021
  9. Descendant · 2 generations on · 0 of its ownK213214 Xpert WristNewclip Technics · 2021

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2014: 12016: 22018: 12021: 22022: 12026: 1
2014high 2 (2016) · low 0 (2015)2026

Most influential descendants

Showing 5 of 8 · See all
  • K173641Activ AnkleNewclip Technics · 2018 · cites it directly3descendants
  • K261511Xpert AnkleNewclip Technics · 2026 · 2 generations on0descendants
  • K221395Footmotion Plating SystemNewclip Technics · 2022 · 2 generations on0descendants
  • K202803Activmotion S DTONewclip Technics · 2021 · cites it directly0descendants
  • K213214Xpert WristNewclip Technics · 2021 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K000684Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa)20001
−2K060710Universal Locking System, 3.5MM Plates and Screws-4936 Plates,4835 ScrewsZimmer, Inc.20065
−1K082527Zimmer Universal Locking System: 3.5 MM Locking Plates and ScrewsZimmer, Inc.20085
0 (this device)K113652Loqteq Small Fragment Set Loqteq Cortical SCREW3.5, Small Head, T15, Self…Aap Implantate AG2012—
+1K173641Activ AnkleNewclip Technics2018—
+2K261511Xpert AnkleNewclip Technics2026—
+2K221395Footmotion Plating SystemNewclip Technics2022—
+1K202803Activmotion S DTONewclip Technics2021—
+2K213214Xpert WristNewclip Technics2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201620
201810
202120
202210
202610
FIG. 1 — Lineage of K113652, 2000–2026Source: 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
*K000684Small Fragment Dynamic Compression Locking (DCL) System
Summary page 1
…ics/87/ HWC: Screw, Fixation, Bone Predicate device: Small Fragment Locking Compression Plate (LCPO) System, Synthes (USA), K000684 (APR 28, 2000) and K011335 (JUL 27, 2001) and Zimmere Small Fragment Universal Locking System K08…
Synthes (Usa)20001
*K011335Synths One-Third Tubular DCL Plate
Summary page 1
…n, Bone Predicate device: Small Fragment Locking Compression Plate (LCPO) System, Synthes (USA), K000684 (APR 28, 2000) and K011335 (JUL 27, 2001) and Zimmere Small Fragment Universal Locking System K082527 (DEC 18,…
Synthes (Usa)20012
*K082527Zimmer Universal Locking System: 3.5 MM Locking Plates and Screws
Summary page 1
…Synthes (USA), K000684 (APR 28, 2000) and K011335 (JUL 27, 2001) and Zimmere Small Fragment Universal Locking System K082527 (DEC 18, 2008) Device Description: Bone plates and screws are used for fixation of b…
Zimmer, Inc.20085

Also cleared against K000684: 68 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K173641Activ AnkleNewclip Technics20183
K202803Activmotion S DTONewclip Technics20210
K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ®…Aap Implantate AG20160
K161703LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, WasherAap Implantate AG20160
K141949Cortical Screw 3.5, T15, Self-Tapping, Titanium, Cortical Screw 4.5, T25, Self Tapping…Aap Implantate AG20140

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 12 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
  • 4 of the 4 ancestors have a recall of any class.
  • Of its descendants, K173641 (Newclip Technics, 2018) has gone furthest, with 3 descendants of its own.
  • 68 other devices also cite its predicate K000684.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

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 aap LOQTEQ Small Fragment Set includes Straight Plates 3.5, Reconstruction Plates 3.5 and One Third Tubular Plates 3.5. The plates accept 3.5 mm locking screws and 3.5 mm cortical screws. They are intended for

Fixation of fractures, osteotomies, and non-unions of the scapula, olecranon, humerus, radius, ulna, distal tibia, and fibula, particularly in osteopenic bone

Indications for use as stated in the FDA summary.

Also cleared against K000684

68 other devices cite the same predicate.

  • K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda. · 2026
  • K242988Genostis Osteosynthesis SystemGenostis AF · 2025
  • K243469SignexOsteonic Co., Ltd. · 2025
  • K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior…Bonebridge AG · 2024
  • K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited · 2024
  • K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating SystemDePuy Synthes · 2024

More from Aap Implantate AG

37 FDA decisions under this applicant name. See the company

  • K254253LOQTEQ® VA Proximal Humerus Plate 3.5Aap Implantate AG · 2026
  • K233008Cannulated Headless Bone ScrewsAap Implantate AG · 2024
  • K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG · 2023
  • K211582LOQTEQ Proximal Humerus Plate 3.5 SystemAap Implantate AG · 2021
  • K210043LOQTEQ Distal Lateral Femur Plate 4.5 SystemAap Implantate AG · 2021

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/K113652 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113652: Loqteq Small Fragment Set Loqteq Cortical SCREW3.5, Small Head, T15, Self Tapping Loqteq Cortical Screw 3.5, T15, Self T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113652

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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