510(k) Report

510(k) · Cleared

Cleared

LOQTEQ VA Foot Plates 2.5

K182785510(k) TraditionalCleared Jun 19, 2019261-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 Jun 19, 2019 as substantially equivalent to K150520 (Wrightmedicaltechnologyinc, 2015) and 5 other predicates after a 261-day review. Its family tree reaches back 10 generations to 1996.

Decided
Jun 19, 2019
Review
261 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
6

Its longest line of descent runs back 10 generations to K954385 (1996). 108 ancestors in all, the oldest K885250 (1989). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2015: 2 other ancestors2012: 1 other ancestor2009: 5 other ancestors2007: 3 other ancestors2013: 4 other ancestors2011: 3 other ancestors2010: 6 other ancestors2008: 2 other ancestors2006: 7 other ancestors2004: 5 other ancestors2002: 6 other ancestors2005: 5 other ancestors2003: 3 other ancestors2001: 10 other ancestors1998: 3 other ancestors2000: 6 other ancestors1996: 10 other ancestors1995: 3 other ancestors1994: 4 other ancestors1992: 1 other ancestor1991: 1 other ancestor1989: 2 other ancestors1999: 2 other ancestors1997: 2 other ancestors1990: 2 other ancestorsK954385 · Synthes Mandibular Modular Fixation System · Synthes (Usa) · 1996K974555 · Synthes 2.0 MM Locking Plate System (2.0 LPS) · Synthes (Usa) · 1998K030448 · Osteomed 2.0 Locking Plates and Screws · Osteomed LP · 2003K032442 · KLS-Martin Mandibular/Reconstruction System II · KLS-Martin L.P. · 2003K040598 · KLS Martin Hand Plating System · KLS-Martin L.P. · 2004K050868 · Maxlock · Orthohelix Surgical Designs, Inc. · 2005K073624 · Modular Foot System · Orthohelix Surgical Designs, Inc. · 2008 · recalledK100618 · Maxlock Extreme Extremity Plating System with Variable Angle Technology · Orthohelix Surgical Designs, Inc. · 2010K113014 · Claw II Polyaxial Compression System and Ortholoc 3DSI Locking Screws · Wrightmedicaltechnologyinc · 2012 · recalledK121651 · Ortholoc 3DI Midfoot/Flatfoot System · Wrightmedicaltechnologyinc · 201219851990199520002005201020152020
  1. Root · 10 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
  2. 6 generations between
  3. 3 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
  4. 2 generations backK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
  5. 1 generation backK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
  6. This deviceK182785 LOQTEQ VA Foot Plates 2.5Aap Implantate AG · 2019
Show all 10 generations
  1. Root · 10 generations backK954385 Synthes Mandibular Modular Fixation SystemSynthes (Usa) · 1996
  2. 9 generations backK974555 Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa) · 1998
  3. 8 generations backK030448 Osteomed 2.0 Locking Plates and ScrewsOsteomed LP · 2003
  4. 7 generations backK032442 KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P. · 2003
  5. 6 generations backK040598 KLS Martin Hand Plating SystemKLS-Martin L.P. · 2004
  6. 5 generations backK050868 MaxlockOrthohelix Surgical Designs, Inc. · 2005
  7. 4 generations backK073624 Modular Foot SystemOrthohelix Surgical Designs, Inc. · 2008 · Recalled
  8. 3 generations backK100618 Maxlock Extreme Extremity Plating System with Variable Angle…Orthohelix Surgical Designs, Inc. · 2010
  9. 2 generations backK113014 Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc · 2012 · Recalled
  10. 1 generation backK121651 Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc · 2012
  11. This deviceK182785 LOQTEQ VA Foot Plates 2.5Aap Implantate AG · 2019
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K954385Synthes Mandibular Modular Fixation SystemSynthes (Usa)1996—
−9K974555Synthes 2.0 MM Locking Plate System (2.0 LPS)Synthes (Usa)1998—
−8K030448Osteomed 2.0 Locking Plates and ScrewsOsteomed LP2003—
−7K032442KLS-Martin Mandibular/Reconstruction System IIKLS-Martin L.P.2003—
−6K040598KLS Martin Hand Plating SystemKLS-Martin L.P.2004—
−5K050868MaxlockOrthohelix Surgical Designs, Inc.2005—
−4K073624Modular Foot SystemOrthohelix Surgical Designs, Inc.20081
−3K100618Maxlock Extreme Extremity Plating System with Variable Angle TechnologyOrthohelix Surgical Designs, Inc.2010—
−2K113014Claw II Polyaxial Compression System and Ortholoc 3DSI Locking ScrewsWrightmedicaltechnologyinc201212
−1K121651Ortholoc 3DI Midfoot/Flatfoot SystemWrightmedicaltechnologyinc2012—
0 (this device)K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198920
199020
199110
199210
199440
199530
1996100
199720
199830
199920
200060
2001100
200260
200330
200450
200550
200670
200730
200820
200950
201060
201130
201210
201340
201520
FIG. 1 — Lineage of K182785, 1996–2019Source: 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? (6)

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
*K150520DARCO Locking Bone Plate System
Summary page 5
…ice: Orthopedics Product Code: HRS and HWC Predicate Devices 510(K) Number Trade Name Manufacturer K150520 DARCO® Locking Bone Plate System Wright Medical K121651 ORTHOLOC 3Di Midfoot/Flatfoot Syst…
Wrightmedicaltechnologyinc2015—
*K121651Ortholoc 3DI Midfoot/Flatfoot System
Summary page 5
…510(K) Number Trade Name Manufacturer K150520 DARCO® Locking Bone Plate System Wright Medical K121651 ORTHOLOC 3Di Midfoot/Flatfoot System Wright Medical K120359 ORTHOLOCTM 3Di Hallux System-Pri…
Wrightmedicaltechnologyinc2012—
*K120359Ortholoc 3DI Hallux System
Summary page 5
…K150520 DARCO® Locking Bone Plate System Wright Medical K121651 ORTHOLOC 3Di Midfoot/Flatfoot System Wright Medical K120359 ORTHOLOCTM 3Di Hallux System-Primary Predicate Wright Medical ORTHOLOC® 2.0/2.4 Plate & ORTHOL…
Wrightmedicaltechnologyinc20122
*K090692Ortholoc 2.0/2.4 Plate System
Summary page 5
…K120359 ORTHOLOCTM 3Di Hallux System-Primary Predicate Wright Medical ORTHOLOC® 2.0/2.4 Plate & ORTHOLOC®2 .0/2 .4 Wright Medical K090692 Screw K182786 - Page 2 o…
Wrightmedicaltechnologyinc20091
*K071264Synthes (Usa) 2.4/2.7 MM Locking Foot Module
Summary page 6
…K182786 - Page 2 of 8 510(k) Traditional Premarket Notification aap LOQTEQ® VA Foot Plates 2.5 K071264 Synthes (USA) 2.4/2.7mm Locking Foot Module Synthes K150456 Arthrex Plates, Screws, and Staple…
Synthes (Usa)2007—
*K150456Arthrex Plates, Screws, and Staples
Summary page 6
…) Traditional Premarket Notification aap LOQTEQ® VA Foot Plates 2.5 K071264 Synthes (USA) 2.4/2.7mm Locking Foot Module Synthes K150456 Arthrex Plates, Screws, and Staples Arthrex Table 1: List of predicate devices Intended Use: The…
Arthrex, Inc.2015—

Also cleared against K150520: 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 23 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
  • 25 of the 108 ancestors have a recall of any class.
  • 1 other device also cites its predicate K150520.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?

LOQTEQ® VA Plantar Fusion Plate 2.5, TMT 1: • plantar stabilization of arthrodesis/fusions of the first metatarsal joint (Lapidus procedure) LOQTEQ® VA L-Fusion Plate 2.5: • LisFranc Arthrodesis and/or Stabilization • 2nd Tarsometatarsal (TMT) Fusions LOQTEQ® VA Straight Fusion Plate 2.5: • LisFranc Arthrodesis and/or Stabilization • 3rd Tarsometatarsal (TMT) Fusions LOQTEQ® VA Osteotomy Plate 2.5: First metatarsal osteotomies for hallux valgus…

Read the full statement (217 words)

LOQTEQ® VA Plantar Fusion Plate 2.5, TMT 1:

• plantar stabilization of arthrodesis/fusions of the first metatarsal joint (Lapidus procedure)

LOQTEQ® VA L-Fusion Plate 2.5:

• LisFranc Arthrodesis and/or Stabilization

• 2nd Tarsometatarsal (TMT) Fusions

LOQTEQ® VA Straight Fusion Plate 2.5:

• LisFranc Arthrodesis and/or Stabilization

• 3rd Tarsometatarsal (TMT) Fusions

LOQTEQ® VA Osteotomy Plate 2.5:

First metatarsal osteotomies for hallux valgus correction including:

• Opening base wedge osteotomy

• Closing base wedge osteotomy

• Proximal Chevron osteotomy

LOQTEQ® VA MTP Fusion Plate 2.5:

Arthrodesis of the first metatarsophalangeal joint (MTP) including:

• Primary MTP Fusion due to hallux rigidus and/or hallux valgus

LOQTEQ® VA MTP Revision Plate 2.5:

Arthrodesis of the first metatarsophalangeal joint (MTP) including:

• Revision MTP Fusion

• Revision of failed first MTP Arthroplasty implant

LOQTEQ® VA Metatarsal Straight Plate 2.5/LOQTEQ® VA Metatarsal L-Plate 2.5/LOQTEQ® VA Metatarsal T-Plate 2.5

• Metatarsal or metacarpal fractures and osteotomies

• Phalanges fractures and osteotomies

LOQTEQ® VA X-Plate 2.5:

• fixation of factures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including the foot

LOQTEQ® VA Hook Plate 2.5:

• internal bone fixation for bone fractures of the 5th metatarsal of the foot

LOQTEQ® VA Plantar Fusion Plate 3.5, TMT 1:

• plantar stabilization of arthrodesis/fusions of the first metatarsal joint (Lapidus procedure)

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K182785: LOQTEQ VA Foot Plates 2.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182785

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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