510(k) · Cleared
ClearedAuto-Drive Bone Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed Corp. · HWC Screw, Fixation, Bone
Cleared on Mar 18, 1998 as substantially equivalent to K944565 (KLS-Martin L.P., 1994) and 1 other predicate after an 86-day review. Its family tree reaches back 3 generations to 1976. 141 later devices descend from it.
- Decided
- Mar 18, 1998
- Review
- 86 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K761228 (1976). 12 ancestors in all. 141 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 2 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 1 generation backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- This deviceK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- Descendant · cites it directly · 117 of its ownK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
- Descendant · 2 generations on · 101 of its ownK032228 Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003
- Descendant · 3 generations on · 100 of its ownK033740 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003
- Descendant · 2 generations on · 87 of its ownK063506 Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006
- Descendant · 3 generations on · 84 of its ownK110574 Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · Recalled
Showing 5 of 141 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 141 · See all- K013954Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002 · cites it directly117descendants
- K032228Lorenz 2.4 Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2003 · 2 generations on101descendants
- K033740Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2003 · 3 generations on100descendants
- K063506Lorenz Sternal Closure SystemWalter Lorenz Surgical, Inc. · 2006 · 2 generations on87descendants
- K110574Biomet Microfixation Sternalock Blu Sternal Closure SystemBiomet Microfixation, Inc. · 2011 · 3 generations on84descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −2 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −1 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| 0 (this device) | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| +1 | K013954 | Lorenz Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2002 | — |
| +2 | K032228 | Lorenz 2.4 Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2003 | — |
| +3 | K033740 | Lorenz Sternal Closure System | Walter Lorenz Surgical, Inc. | 2003 | — |
| +2 | K063506 | Lorenz Sternal Closure System | Walter Lorenz Surgical, Inc. | 2006 | — |
| +3 | K110574 | Biomet Microfixation Sternalock Blu Sternal Closure System | Biomet Microfixation, Inc. | 2011 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 6 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 6 | 0 |
| 2013 | 4 | 0 |
| 2014 | 8 | 0 |
| 2015 | 10 | 0 |
| 2016 | 8 | 0 |
| 2017 | 1 | 0 |
| 2018 | 6 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 7 | 0 |
| 2023 | 10 | 0 |
| 2024 | 16 | 0 |
| 2025 | 17 | 0 |
| 2026 | 14 | 0 |
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 K203011 Monster Screw Systemscore 22.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K944565 | KLS-Martin Micro Osteosythesis System (1.5MM)Summary page 1…8 mm. Equivalence for this device is based on similarities in intended use, material, design and operational principle to the KLS Martin Centre-Drive Drill-free™ Screw (K944565) and the Leibinger® Self-Drilling Screw (K970912). All of the screw systems are intended for use in internal fixation of small bo… | 1994 |
| * | K970912 | Leibinger Self-Drilling ScrewSummary page 1…milarities in intended use, material, design and operational principle to the KLS Martin Centre-Drive Drill-free™ Screw (K944565) and the Leibinger® Self-Drilling Screw (K970912). All of the screw systems are intended for use in internal fixation of small bones including the cranifacial and maxillofacial s… | 1997 |
What descends from it? (141)
See all 1416 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013954 | Lorenz Self Drilling Screws | 2002 | 117 |
| K023260 | 1.2MM Osteomed Auto-Drive Screw System | 2002 | 24 |
| K022890 | Modified Screw Designs for Use with the Bioplate Rigid Fixation Bone Plating System for… | 2002 | 7 |
| K030806 | Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery | 2003 | 5 |
| K151195 | OsteoMed IMF Screw | 2015 | 0 |
| K122049 | Neuropro Low Profile Cranial Plating System | 2013 | 0 |
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 22 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K013954 (Walter Lorenz Surgical, Inc., 2002) has gone furthest, with 117 descendants of its own.
- 14 other devices also cite its predicate K944565.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
Fixation secondary to trauma or reconstruction of the craniofacial and maxillofacial skeleton and bones of the hand
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974785 · printed Nov 3, 2026
Cite this page
510(k) Report. “K974785: Auto-Drive Bone Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K974785
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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