510(k) Report

510(k) · Cleared

Cleared

Aap Aps System

K071852510(k) TraditionalCleared Aug 29, 200755-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 · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Aug 29, 2007 as substantially equivalent to K791619 (Synthes (Usa), 1979) and 4 other predicates after a 55-day review. Its family tree reaches back 2 generations to 1979. 4 later devices descend from it.

Decided
Aug 29, 2007
Review
55 days
Class
Class II
Product code
KTT
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K791619 (1979). 6 ancestors in all. 4 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor1997: 1 other ancestor1984: 1 other ancestor1986: 1 other ancestor2012: 1 descendant cleared2023: 1 descendant cleared2021: 1 descendant cleared2020: 1 descendant clearedK791619 · Dynamic Hip Screw · Synthes (Usa) · 1979K972629 · Depuy AE TK2 Hip Screw System · Depuy, Inc. · 1997 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 2 descendants K972629 · Depuy AE TK2 Hip Screw System · Depuy, Inc. · 1997 · recalledK791619 · Dynamic Hip Screw · Synthes (Usa) · 19790
  1. Root · 2 generations backK791619 Dynamic Hip ScrewSynthes (Usa) · 1979
  2. 1 generation backK972629 Depuy AE TK2 Hip Screw SystemDepuy, Inc. · 1997 · Recalled
  3. This deviceK071852 Aap Aps SystemAap Implantate AG · 2007
  4. Descendant · cites it directly · 2 of its ownK120360 Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited · 2012
  5. Descendant · 2 generations on · 1 of its ownK202764 Ortho Solutions Plating SystemOrtho Solutions UK, Ltd. · 2020
  6. Descendant · cites it directly · 0 of its ownK221787 Auxein's DHS/DCS Plate SystemAuxein Medical Private Limited · 2023
  7. Descendant · 2 generations on · 0 of its ownK210658 Volition Plating SystemOrtho Solutions UK, Ltd. · 2021

Most influential descendants

Showing 4 of 4 · See all
  • K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited · 2012 · cites it directly2descendants
  • K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd. · 2020 · 2 generations on1descendant
  • K221787Auxein's DHS/DCS Plate SystemAuxein Medical Private Limited · 2023 · cites it directly0descendants
  • K210658Volition Plating SystemOrtho Solutions UK, Ltd. · 2021 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K791619Dynamic Hip ScrewSynthes (Usa)1979—
−1K972629Depuy AE TK2 Hip Screw SystemDepuy, Inc.19972
0 (this device)K071852Aap Aps SystemAap Implantate AG2007—
+1K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited2012—
+2K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.2020—
+1K221787Auxein's DHS/DCS Plate SystemAuxein Medical Private Limited2023—
+2K210658Volition Plating SystemOrtho Solutions UK, Ltd.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198610
199710
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
202010
202110
202310
FIG. 1 — Lineage of K071852, 1979–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 KTT? 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 KTT device

  1. #1 K242861 TrueLok Elevatescore 21.4 · 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? (5)

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
*K791619Dynamic Hip Screw
Summary page 3
…on. Predicate Devices for Substantial Equivalence: The APS-System is similar in size, material and intended use to the * Synthes Dynamic Hip Screw (DHS) System (K791619), * Synthes Dynamic Condylar Screw (DCS) System (K840954), * DePuy ACE TK2 Hip Screw System (K972629), -…
Synthes (Usa)1979—
*K840954Dynamic Condylar Screw or D.C.S.
Summary page 3
…m is similar in size, material and intended use to the * Synthes Dynamic Hip Screw (DHS) System (K791619), * Synthes Dynamic Condylar Screw (DCS) System (K840954), * DePuy ACE TK2 Hip Screw System (K972629), - Precimed Hip Screw System (K023851), * Corifix Dynamic Hi…
Synthes (Usa)1984—
*K972629Depuy AE TK2 Hip Screw System
Summary page 3
…he * Synthes Dynamic Hip Screw (DHS) System (K791619), * Synthes Dynamic Condylar Screw (DCS) System (K840954), * DePuy ACE TK2 Hip Screw System (K972629), - Precimed Hip Screw System (K023851), * Corifix Dynamic Hip Screw System (K973231) Comparision of the techno…
Depuy, Inc.19972
*K023851Precimed Hip Screw System
Summary page 3
…stem (K791619), * Synthes Dynamic Condylar Screw (DCS) System (K840954), * DePuy ACE TK2 Hip Screw System (K972629), - Precimed Hip Screw System (K023851), * Corifix Dynamic Hip Screw System (K973231) Comparision of the technological Characteristics of the device to the pr…
Precimed, Inc.2003—
*K973231The Corifix Dynamic Hip Screw System
Summary page 3
…ew (DCS) System (K840954), * DePuy ACE TK2 Hip Screw System (K972629), - Precimed Hip Screw System (K023851), * Corifix Dynamic Hip Screw System (K973231) Comparision of the technological Characteristics of the device to the predicate legally marketed devices: There are no signifi…
Corin USA1997—

Also cleared against K791619: 11 other devices →

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited20122
K221787Auxein's DHS/DCS Plate SystemAuxein Medical Private Limited20230

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 28 years and passes through 3 companies; a new generation was cleared every 18.1 years on median.
  • 1 of the 6 ancestors has a recall of any class.
  • Of its descendants, K120360 (Ortho Solutions Limited, 2012) has gone furthest, with 2 descendants of its own.
  • 11 other devices also cite its predicate K791619.

How does its category compare?

All KTT devices

KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · KTT

10in 2025

2007: 92008: 112009: 112010: 122011: 102012: 92013: 72014: 142015: 122016: 102017: 112018: 62019: 82020: 92021: 102022: 32023: 72024: 52025: 102026 (partial year): 5
2007high 14 (2014) · low 3 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTT

88in 2025

2007: 55 days median2008: 73 days median2009: 94 days median2010: 148 days median2011: 157 days median2012: 140 days median2013: 87 days median2014: 129 days median2015: 60 days median2016: 142 days median2017: 184 days median2018: 149 days median2019: 110 days median2020: 200 days median2021: 83 days median2022: 25 days median2023: 29 days median2024: 90 days median2025: 88 days median2026 (partial year): 68 days median
2007high 200 (2020) · low 25 (2022)2026

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

Recalls per year · KTT

2in 2021

2007: 22008: 12009: 22010: 12012: 42013: 72017: 12018: 142019: 32021: 22026 (partial year): 11
2007high 14 (2018) · low 0 (2011)2026

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

Adverse event reports per year · KTT

673in 2025

2007: 452008: 662009: 452010: 1212011: 1962012: 5272013: 8982014: 4452015: 4012016: 4002017: 4852018: 5972019: 8002020: 9422021: 9612022: 6272023: 5542024: 5232025: 673
2007high 961 (2021) · low 45 (2007)2025

MAUDE reports naming product code KTT, 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
2007955245
20081173166
20091194245
2010121481121
2011101570196
201291404527
20137877898
2014141290445
201512600401
2016101420400
2017111841485
2018614914597
201981103800
202092000942
202110832961
20223250627
20237290554
20245900523
202510880673
202656811—

What is it indicated for?

125°-150 ° Hip Plate: fractures of the trochanter region, simple and multifragmentary pertrochanteric, intertrochanteric

95° Condylar Plate: distal and intercondylar fratures of the femur

Indications for use as stated in the FDA summary.

Also cleared against K791619

11 other devices cite the same predicate.

  • K221787Auxein's DHS/DCS Plate SystemAuxein Medical Private Limited · 2023
  • K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma · 2021
  • K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes · 2019
  • K172872DePuy Synthes Femoral Neck SystemDePuy Synthes · 2018
  • K150818Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation SystemZimmer, Inc. · 20156 recalls
  • K984331Odi Ultimate Compression Hip ScrewOrthopedic Designs, Inc. · 1999

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 KTT

The KTT category page

  • K263083Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC · 2026
  • K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC · 2026
  • K260900DYNEX® External Fixation SystemsVilex, LLC · 2026
  • K260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc. · 2026
  • K253291Excelsior SystemBlue Ocean Global · 2026

https://510kreport.com/device/K071852 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071852: Aap Aps System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071852

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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