510(k) Report

510(k) · Cleared

Cleared

Synthes Maxillofacial Titanium Micro Set

K912932510(k) TraditionalCleared Sep 25, 199182-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

Synthes (Usa) · HRS Plate, Fixation, Bone

Cleared on Sep 25, 1991 after an 82-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 38 later devices descend from it.

Decided
Sep 25, 1991
Review
82 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
0

38 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2002: 3 descendants cleared2006: 1 descendant cleared2019: 1 descendant cleared1997: 2 descendants cleared2020: 1 descendant cleared2008: 2 descendants cleared2005: 4 descendants cleared2003: 1 descendant cleared1999: 2 descendants cleared2015: 3 descendants cleared2012: 1 descendant cleared2013: 1 descendant cleared2010: 1 descendant cleared2016: 1 descendant cleared2025: 1 descendant cleared2004: 2 descendants cleared2007: 1 descendant cleared2024: 2 descendants cleared2009: 1 descendant cleared2014: 2 descendants cleared2026: 2 descendants cleared2018: 1 descendant cleared2023: 1 descendant cleared2021: 1 descendant cleared1990200020102020
  1. This deviceK912932 Synthes Maxillofacial Titanium Micro SetSynthes (Usa) · 1991
  2. Descendant · cites it directly · 25 of its ownK963030 Leibinger Imf ScrewHowmedica Leibinger, Inc. · 1997
  3. Descendant · 2 generations on · 11 of its ownK050535 Stryker MMF ScrewStryker Instruments · 2005
  4. Descendant · 3 generations on · 10 of its ownK122313 Stryker Universal Smartlock Hybrid MMF SystemStryker · 2012
  5. Descendant · 2 generations on · 9 of its ownK983728 Lorenz Imf ScrewWalter Lorenz Surgical, Inc. · 1999
  6. Descendant · 2 generations on · 8 of its ownK980760 KLS-Martin MMF ScrewKLS-Martin L.P. · 1999

Showing 5 of 38 descendants. See all descendants

Descendants cleared per year

1997: 21999: 22002: 32003: 12004: 22005: 42006: 12007: 12008: 22009: 12010: 12012: 12013: 12014: 22015: 32016: 12018: 12019: 12020: 12021: 12023: 12024: 22025: 12026: 2
1997high 4 (2005) · low 0 (1998)2026

Most influential descendants

Showing 5 of 38 · See all
  • K963030Leibinger Imf ScrewHowmedica Leibinger, Inc. · 1997 · cites it directly25descendants
  • K050535Stryker MMF ScrewStryker Instruments · 2005 · 2 generations on11descendants
  • K122313Stryker Universal Smartlock Hybrid MMF SystemStryker · 2012 · 3 generations on10descendants
  • K983728Lorenz Imf ScrewWalter Lorenz Surgical, Inc. · 1999 · 2 generations on9descendants
  • K980760KLS-Martin MMF ScrewKLS-Martin L.P. · 1999 · 2 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K912932Synthes Maxillofacial Titanium Micro SetSynthes (Usa)1991—
+1K963030Leibinger Imf ScrewHowmedica Leibinger, Inc.1997—
+2K050535Stryker MMF ScrewStryker Instruments2005—
+3K122313Stryker Universal Smartlock Hybrid MMF SystemStryker2012—
+2K983728Lorenz Imf ScrewWalter Lorenz Surgical, Inc.1999—
+2K980760KLS-Martin MMF ScrewKLS-Martin L.P.1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
199920
200230
200310
200420
200540
200610
200710
200820
200910
201010
201210
201310
201420
201530
201610
201810
201910
202010
202110
202310
202420
202510
202620
FIG. 1 — Lineage of K912932, 1991–2026Source: 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 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (38)

See all 38

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

NumberDeviceApplicantDecidedDescendants
K963030Leibinger Imf ScrewHowmedica Leibinger, Inc.199725
K021684The Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20027
K062819Bioplate Rigid Bone Plating System for Craniomaxillofacial SurgeryBioplate, Inc.20063
K022033Sterile Plate & Screw Kit Configurations for Use with the Bioplate Titanium Fixation…Bioplate, Inc.20021
K192702DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalSynthes (USA) Products, LLC20200
K192655Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC20190
K082757Modified Sterile Plate & Screw Kit Configurations for Use with Bioplate Titanium…Bioplate, Inc.20080
K963502Csco Forehead Fixation SystemHowmedica Corp.19970

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, K963030 (Howmedica Leibinger, Inc., 1997) has gone furthest, with 25 descendants of its own.

How does its category compare?

All HRS devices

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

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—

More from Synthes (Usa)

406 FDA decisions under this applicant name. See the company

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  • K110789Synthes Sternal Zipfix SystemSynthes (Usa) · 20113 recalls
  • K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 20112 recalls

Recent decisions in HRS

The HRS category page

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  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
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  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K912932 · printed Nov 4, 2026

Cite this page

510(k) Report. “K912932: Synthes Maxillofacial Titanium Micro Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K912932

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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