510(k) Report

510(k) · Cleared

Cleared

Modus System Self-Drilling Screws

K992106510(k) TraditionalCleared Sep 17, 199987-day reviewClass II21 CFR 888.3040

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

Medartis AG · HWC Screw, Fixation, Bone

Cleared on Sep 17, 1999 as substantially equivalent to K946165 (Elekta Instruments, Inc., 1995) and 4 other predicates after an 87-day review. Its family tree reaches back 3 generations to 1976.

Decided
Sep 17, 1999
Review
87 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K761228 (1976). 17 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 2 other ancestors1997: 2 other ancestors1995: 1 other ancestor1996: 3 other ancestors1994: 2 other ancestors1991: 1 other ancestor1988: 1 other ancestor1986: 2 other ancestorsK761228 · Luhr Mandibular Compression-Screw System · Howmedica Corp. · 1976K963739 · Leibinger - Luhr Small Orthopedic Bone Screws · Howmedica Leibinger, Inc. · 1997K970912 · Leibinger Self-Drilling Screw · Howmedica Leibinger, Inc. · 1997197519801985199019952000
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 4 other ancestors3 generations back: 6 other ancestors K970912 · Leibinger Self-Drilling Screw · Howmedica Leibinger, Inc. · 1997K963739 · Leibinger - Luhr Small Orthopedic Bone Screws · Howmedica Leibinger, Inc. · 1997K761228 · Luhr Mandibular Compression-Screw System · Howmedica Corp. · 19760
  1. Root · 3 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
  2. 2 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
  3. 1 generation backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
  4. This deviceK992106 Modus System Self-Drilling ScrewsMedartis AG · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K761228Luhr Mandibular Compression-Screw SystemHowmedica Corp.1976—
−2K963739Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc.1997—
−1K970912Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc.1997—
0 (this device)K992106Modus System Self-Drilling ScrewsMedartis AG1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198620
198810
199110
199420
199510
199630
199720
199820
FIG. 1 — Lineage of K992106, 1976–1999Source: 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 HWC? 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 HWC device

  1. #1 K203011 Monster Screw Systemscore 22.2 · 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? (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
*K946165CMF-Titanium Cranio-Maxillo-Facial Fracture Fixation (Osteosynthesis) System
Summary page 1
…le component bone fixation metallic appliances (21 CFR 888.3030) 3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) MODUS System Screws (K946165) Synthes Self-Drilling Maxillofacial Screw (K983485) KLS Martin Drill-Free Screws (K971297) Lorenz Self-Drilling Screw Leibing…
Elekta Instruments, Inc.1995—
*K983485Synthes 1.3 MM Self-Drilling Screw
Summary page 1
…FR 888.3030) 3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) MODUS System Screws (K946165) Synthes Self-Drilling Maxillofacial Screw (K983485) KLS Martin Drill-Free Screws (K971297) Lorenz Self-Drilling Screw Leibinger Self-Drilling Screw (K970912) TIMESH System Screw…
Synthes (Usa)1998—
*K971297Centre-Drive Drill-Free Screw
Summary page 1
…es to which Equivalence is Claimed (Predicate Devices) MODUS System Screws (K946165) Synthes Self-Drilling Maxillofacial Screw (K983485) KLS Martin Drill-Free Screws (K971297) Lorenz Self-Drilling Screw Leibinger Self-Drilling Screw (K970912) TIMESH System Screws (K974107) 4. Description of the Devi…
KLS-Martin L.P.1997—
*K970912Leibinger Self-Drilling Screw
Summary page 1
…Screws (K946165) Synthes Self-Drilling Maxillofacial Screw (K983485) KLS Martin Drill-Free Screws (K971297) Lorenz Self-Drilling Screw Leibinger Self-Drilling Screw (K970912) TIMESH System Screws (K974107) 4. Description of the Device The MODUS?® System Self-drilling Screws are self-tapping self dril…
Howmedica Leibinger, Inc.1997—
*K974017Timesh System
Our OCR of the scanned summary read K974107, FDA’s number for Kodak Digital Science Quality Control Workstation (QCW) (Eastman Kodak Company). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “TIMESH System Screws”.
Sofamor Danek USA,Inc.19981
*—Lorenz Self-Drilling Screw
Named without a submission number
—

Also cleared against K946165: 3 other devices →

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 3 companies; a new generation was cleared every 2.0 years on median.
  • 2 of the 17 ancestors have a recall of any class.
  • 3 other devices also cite its predicate K946165.

How does its category compare?

All HWC devices

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

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

The MODUS System Self-drilling Screws are intended for use in the internal fixation in osteotomies and fractures of the craniofacial skeleton which require positional and functional stability.

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 K946165

3 other devices cite the same predicate.

  • K050934Modus Titanium Osteosynthesis SystemMedartis, Inc. · 2005
  • K992682Modus 2.5 Mandibular Reconstruction SetMedartis AG · 1999
  • K992683Modus 2.5 Mandibular Trauma SetMedartis AG · 1999

More from Medartis AG

42 FDA decisions under this applicant name. See the company

  • K260761APTUS Clavicle System 2.8Medartis AG · 2026
  • K260934TITAN Nail; APTUS K-Wire SystemMedartis AG · 2026
  • K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG · 2026
  • K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG · 2025
  • K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG · 2024

Recent decisions in HWC

The HWC category page

  • K261961Ntegrate Threaded Nail SystemNvision Biomedical Technologies · 2026
  • K263116OsteoCentric Technologies Cannulated and Soild Fasteners with NutsOsteoCentric Technologies · 2026
  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K992106 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992106: Modus System Self-Drilling Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992106

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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