510(k) Report

510(k) · Cleared

Cleared

Auxein's DHS/DCS Plate System

K221787510(k) TraditionalCleared Nov 30, 2023527-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

Auxein Medical Private Limited · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Nov 30, 2023 as substantially equivalent to K071852 (Aap Implantate AG, 2007) and 4 other predicates after a 527-day review. Its family tree reaches back 3 generations to 1979.

Decided
Nov 30, 2023
Review
527 days
Class
Class II
Product code
KTT
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K791619 (1979). 9 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestor1991: 1 other ancestor1984: 1 other ancestor2003: 1 other ancestor1997: 1 other ancestor1986: 1 other ancestorReference device: K213059 · Tibia and Fibula System · Auxein Medical Private Limited · 2023K791619 · Dynamic Hip Screw · Synthes (Usa) · 1979K972629 · Depuy AE TK2 Hip Screw System · Depuy, Inc. · 1997 · recalledK071852 · Aap Aps System · Aap Implantate AG · 200719801990200020102020
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors3 generations back: 1 other ancestor K071852 · Aap Aps System · Aap Implantate AG · 2007K972629 · Depuy AE TK2 Hip Screw System · Depuy, Inc. · 1997 · recalledK791619 · Dynamic Hip Screw · Synthes (Usa) · 19790
  1. Root · 3 generations backK791619 Dynamic Hip ScrewSynthes (Usa) · 1979
  2. 2 generations backK972629 Depuy AE TK2 Hip Screw SystemDepuy, Inc. · 1997 · Recalled
  3. 1 generation backK071852 Aap Aps SystemAap Implantate AG · 2007
  4. This deviceK221787 Auxein's DHS/DCS Plate SystemAuxein Medical Private Limited · 2023
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K791619Dynamic Hip ScrewSynthes (Usa)1979—
−2K972629Depuy AE TK2 Hip Screw SystemDepuy, Inc.19972
−1K071852Aap Aps SystemAap Implantate AG2007—
0 (this device)K221787Auxein's DHS/DCS Plate SystemAuxein Medical Private Limited2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198610
199110
199710
200310
200510
FIG. 1 — Lineage of K221787, 1979–2023Source: 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 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 21.3 · 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
*K071852Aap Aps System
Summary page 5
…he Predicate Device: Following are the predicate device 510(k)s which we are declaring substantial equivalence: Primary Predicate Device 510k Number K071852 K221787 Page ​3/6 Applicant…
Aap Implantate AG2007—
*K052677Synthes Universal Locking Trochanter Stabilization Plate (Ultsp)
Summary page 6
…ion, nail/blade/plate combination, single component Device Name Dynamic Hip Screw Additional Predicate Devices 510k Number K052677 Applicant Synthes (USA) Device Name Synthes Universal Locking Trochanter Stabiliz…
Synthes (Usa)2005—
*K840954Dynamic Condylar Screw or D.C.S.
Summary page 6
…Synthes (USA) Device Name Synthes Universal Locking Trochanter Stabilization Plate (ULTSP) 510k Number K840954 Applicant Synthes (USA) Device Name Dynamic Condylar Screw Or D.C.S. 510k Number…
Synthes (Usa)1984—
*K914546Angled Blade Plate
Summary page 6
…K840954 Applicant Synthes (USA) Device Name Dynamic Condylar Screw Or D.C.S. 510k Number K914546 Applicant Synthes (USA) Device Name Angled Blade Plate 510k Number…
Synthes (Usa)1991—
*K791619Dynamic Hip Screw
Summary page 6
…er K914546 Applicant Synthes (USA) Device Name Angled Blade Plate 510k Number K791619 Applicant Synthes (USA) Device Name Dynamic Hip Screw (DHS)/DCS Compression Screw…
Synthes (Usa)1979—
†K213059Tibia and Fibula SystemAuxein Medical Private Limited2023—

Also cleared against K071852: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 44 years and passes through 4 companies; a new generation was cleared every 16.3 years on median.
  • 1 of the 9 ancestors has a recall of any class.
  • 1 other device also cites its predicate K071852.

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. 2023, 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?

The DHS/DCS Plate System is intended for use in treating fractures of femoral head (Dynamic Hip Plates) and condylar part of the femur (Dynamic Condylar Plates).

Specific indications, which are dependent on the angle of the plate, include:

130°-135°: fractures of the trochanter region, simple and multifragmentary pertrochanteric, intertrochanteric.

95°: distal and intercondylar fractures of the femur.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K071852

1 other device cites the same predicate.

  • K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited · 2012

More from Auxein Medical Private Limited

12 FDA decisions under this applicant name. See the company

  • K213059Tibia and Fibula SystemAuxein Medical Private Limited · 2023
  • K213110AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In AnchorAuxein Medical Private Limited · 2022
  • K213018Auxilock GFS Mini, GFS II Large, and GFS UltimateAuxein Medical Private Limited · 2022
  • K213108Humerus & Ulna SystemAuxein Medical Private Limited · 2022
  • K213014Varixis Elbow SystemAuxein Medical Private Limited · 2022

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The KTT category page

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https://510kreport.com/device/K221787 · printed Nov 6, 2026

Cite this page

510(k) Report. “K221787: Auxein's DHS/DCS 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/K221787

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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