510(k) Report

510(k) · Cleared

Cleared

Miniboneplate System

K951392510(k) TraditionalCleared May 5, 199545-day reviewClass II21 CFR 872.4760

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

Ace Surgical Supply Co., Inc. · JEY Plate, Bone

Cleared on May 5, 1995 after a 45-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 144 later devices descend from it.

Decided
May 5, 1995
Review
45 days
Class
Class II
Product code
JEY
Recalls
None
Predicates
0

144 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2008: 2 descendants cleared2006: 1 descendant cleared2009: 1 descendant cleared2013: 2 descendants cleared2011: 1 descendant cleared2019: 9 descendants cleared2010: 2 descendants cleared2012: 2 descendants cleared2021: 13 descendants cleared2014: 4 descendants cleared2015: 4 descendants cleared2022: 14 descendants cleared2025: 24 descendants cleared2020: 12 descendants cleared2024: 14 descendants cleared2018: 6 descendants cleared2016: 2 descendants cleared2017: 1 descendant cleared2023: 17 descendants cleared2026: 12 descendants cleared1995200020052010201520202025
  1. This deviceK951392 Miniboneplate SystemAce Surgical Supply Co., Inc. · 1995
  2. Descendant · cites it directly · 135 of its ownK073343 Ace Surgical Secure-Mini Implant System, Model 09-270X-XXAce Surgical Supply Co., Inc. · 2008
  3. Descendant · 2 generations on · 134 of its ownK092594 Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-OX…Ace Surgical Supply Co., Inc. · 2009
  4. Descendant · 2 generations on · 127 of its ownK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
  5. Descendant · 3 generations on · 123 of its ownK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
  6. Descendant · 3 generations on · 109 of its ownK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014

Showing 5 of 144 descendants. See all descendants

Descendants cleared per year

2006: 12007: 12008: 22009: 12010: 22011: 12012: 22013: 22014: 42015: 42016: 22017: 12018: 62019: 92020: 122021: 132022: 142023: 172024: 142025: 242026: 12
2006high 24 (2025) · low 1 (2006)2026

Most influential descendants

Showing 5 of 144 · See all
  • K073343Ace Surgical Secure-Mini Implant System, Model 09-270X-XXAce Surgical Supply Co., Inc. · 2008 · cites it directly135descendants
  • K092594Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-OX, 09-2703-OX, 09-2705-OXAce Surgical Supply Co., Inc. · 2009 · 2 generations on134descendants
  • K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013 · 2 generations on127descendants
  • K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014 · 3 generations on123descendants
  • K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc. · 2014 · 3 generations on109descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951392Miniboneplate SystemAce Surgical Supply Co., Inc.1995—
+1K073343Ace Surgical Secure-Mini Implant System, Model 09-270X-XXAce Surgical Supply Co., Inc.2008—
+2K092594Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-OX…Ace Surgical Supply Co., Inc.2009—
+2K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013—
+3K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014—
+3K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart…Neodent USA, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200710
200820
200910
201020
201110
201220
201320
201440
201540
201620
201710
201860
201990
2020120
2021130
2022140
2023170
2024140
2025240
2026120
FIG. 1 — Lineage of K951392, 1995–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JEY? 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 JEY device

  1. #1 K252246 Leforte MMF Systemscore 15.6 · 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (144)

See all 144

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

NumberDeviceApplicantDecidedDescendants
K073343Ace Surgical Secure-Mini Implant System, Model 09-270X-XXAce Surgical Supply Co., Inc.2008135
K061397Ace Surgical Orthodontic Bone Screw Systems, 1.2/1.5 MM X 6MM,8MM, Model…Ace Surgical Supply Co., Inc.20066
K080074Ace Surigical Tru-Fix Implant System, Model 454-180X-XXAce Surgical Supply Co., Inc.20085
K062436Sis Sinus Implant StabilizerMondeal Medical Systems GmbH20070

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?

  • Of its descendants, K073343 (Ace Surgical Supply Co., Inc., 2008) has gone furthest, with 135 descendants of its own.

How does its category compare?

All JEY devices

JEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JEY

2in 2025

2007: 92008: 72009: 42010: 62011: 52012: 102013: 82014: 62015: 72016: 12017: 52018: 72019: 62020: 62021: 42022: 52023: 22024: 52025: 22026 (partial year): 3
2007high 10 (2012) · low 1 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JEY

159in 2024

2007: 115 days median2008: 84 days median2009: 121 days median2010: 199 days median2011: 75 days median2012: 194 days median2013: 126 days median2014: 223 days median2015: 160 days median2017: 190 days median2018: 255 days median2019: 163 days median2020: 198 days median2021: 299 days median2022: 135 days median2024: 159 days median2026 (partial year): 258 days median
2007high 299 (2021) · low 75 (2011)2026

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

Recalls per year · JEY

1in 2020

2008: 32009: 62010: 852013: 12020: 1
2007high 85 (2010) · low 0 (2007)2026

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

Adverse event reports per year · JEY

1,003in 2025

2007: 292008: 242009: 932010: 2152011: 2412012: 4282013: 7662014: 6162015: 7672016: 5582017: 5682018: 6082019: 5952020: 6802021: 4512022: 3442023: 4952024: 6962025: 1,003
2007high 1,003 (2025) · low 24 (2008)2025

MAUDE reports naming product code JEY, 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
20079115029
2008784324
20094121693
2010619985215
20115750241
2012101940428
201381261766
201462230616
201571600767
20161—0558
201751900568
201872550608
201961630595
202061981680
202142990451
202251350344
20232—0495
202451590696
20252—01,003
202632580—

More from Ace Surgical Supply Co., Inc.

21 FDA decisions under this applicant name. See the company

  • K093518Ace Surgical Secure Locator 3.25 Implant SystemAce Surgical Supply Co., Inc. · 20101 recall
  • K092594Ace Surgical Secure- Mini Locator Implant System, Model 09-2702-OX, 09-2703-OX, 09-2705-OXAce Surgical Supply Co., Inc. · 2009
  • K073343Ace Surgical Secure-Mini Implant System, Model 09-270X-XXAce Surgical Supply Co., Inc. · 2008
  • K080074Ace Surigical Tru-Fix Implant System, Model 454-180X-XXAce Surgical Supply Co., Inc. · 2008
  • K061397Ace Surgical Orthodontic Bone Screw Systems, 1.2/1.5 MM X 6MM,8MM, Model 454-91001,454-91002 and 1.2/1.5MM X…Ace Surgical Supply Co., Inc. · 2006

Recent decisions in JEY

The JEY category page

  • K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual…KLS-Martin L.P. · 2026
  • K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd. · 2026
  • K252246Leforte MMF SystemJeil Medical Corporation · 2026
  • K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty), Ltd. · 2025
  • K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OY · 2025

https://510kreport.com/device/K951392 · printed Nov 4, 2026

Cite this page

510(k) Report. “K951392: Miniboneplate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951392

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026