510(k) · Cleared
Cleared1.2MM Osteomed Auto-Drive Screw System
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 Oct 18, 2002 as substantially equivalent to K974785 (Osteomed Corp., 1998) and 2 other predicates after an 18-day review. Its family tree reaches back 4 generations to 1976. 24 later devices descend from it.
- Decided
- Oct 18, 2002
- Review
- 18 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K761228 (1976). 15 ancestors in all. 24 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 3 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 2 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- 1 generation backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- This deviceK023260 1.2MM Osteomed Auto-Drive Screw SystemOsteomed Corp. · 2002
- Descendant · cites it directly · 12 of its ownK031659 Universal Neuro SystemStryker Instruments · 2003
- Descendant · 2 generations on · 9 of its ownK112557 Stryker Universal Neuro 3 SystemStryker · 2012
- Descendant · cites it directly · 5 of its ownK073342 Salvin Dental Specialties, Inc., Fixation ScrewSalvin Dental Specialties, Inc. · 2008
- Descendant · 3 generations on · 4 of its ownK120352 Stryker Quikflap Sterile Procedure PackStryker · 2012 · Recalled
- Descendant · cites it directly · 4 of its ownK063589 Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC · 2007
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K031659Universal Neuro SystemStryker Instruments · 2003 · cites it directly12descendants
- K112557Stryker Universal Neuro 3 SystemStryker · 2012 · 2 generations on9descendants
- K073342Salvin Dental Specialties, Inc., Fixation ScrewSalvin Dental Specialties, Inc. · 2008 · cites it directly5descendants
- K120352Stryker Quikflap Sterile Procedure PackStryker · 2012 · 3 generations on4descendants
- K063589Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC · 2007 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −3 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −2 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −1 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| 0 (this device) | K023260 | 1.2MM Osteomed Auto-Drive Screw System | Osteomed Corp. | 2002 | — |
| +1 | K031659 | Universal Neuro System | Stryker Instruments | 2003 | — |
| +2 | K112557 | Stryker Universal Neuro 3 System | Stryker | 2012 | — |
| +1 | K073342 | Salvin Dental Specialties, Inc., Fixation Screw | Salvin Dental Specialties, Inc. | 2008 | — |
| +3 | K120352 | Stryker Quikflap Sterile Procedure Pack | Stryker | 2012 | 18 |
| +1 | K063589 | Gso Bone Fixation Fasteners | Gold Standard Orthopaedics, LLC | 2007 | — |
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 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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 22.2 · 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? (3)
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 |
|---|---|---|---|
| * | K974785 | Auto-Drive Bone ScrewSummary page 1…for this device is based on similarities in intended use, material, design and operational principle to the OsteoMed Auto-Drive Bone Screw (K974785), the Synthes 1.3mm Self-Drilling Screw (K983485), and the Leibinger Self-Drilling Screw (K970912).… | 1998 |
| * | K983485 | Synthes 1.3 MM Self-Drilling ScrewSummary page 1…ded use, material, design and operational principle to the OsteoMed Auto-Drive Bone Screw (K974785), the Synthes 1.3mm Self-Drilling Screw (K983485), and the Leibinger Self-Drilling Screw (K970912). Due to the similarity of materials and design t… | 1998 |
| * | K970912 | Leibinger Self-Drilling ScrewSummary page 1…le to the OsteoMed Auto-Drive Bone Screw (K974785), the Synthes 1.3mm Self-Drilling Screw (K983485), and the Leibinger Self-Drilling Screw (K970912). Due to the similarity of materials and design to both pre-enactment and post- enactment devices,… | 1997 |
What descends from it? (24)
See all 244 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 26 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K031659 (Stryker Instruments, 2003) has gone furthest, with 12 descendants of its own.
- 5 other devices also cite its predicate K974785.
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?
Indicated for fixation secondary to trauma or reconstruction of the craniofacial and maxillofacial skeleton and bones of the hand. 1.2mm Auto-Drive Screws are intended for single patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023260 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023260: 1.2MM Osteomed Auto-Drive Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023260
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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