510(k) · Cleared
ClearedOsteoMed IMF Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed · DZL Screw, Fixation, Intraosseous
Cleared on Sep 21, 2015 as substantially equivalent to K962774 (Osteomed Corp., 1997) and 1 other predicate after a 140-day review. Its family tree reaches back 4 generations to 1976.
- Decided
- Sep 21, 2015
- Review
- 140 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K761228 (1976). 14 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK151195 OsteoMed IMF ScrewOsteomed · 2015
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) | K151195 | OsteoMed IMF Screw | Osteomed | 2015 | — |
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 | 2 | 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 DZL? 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 DZL device
- #1 K254286 Guided Bone Regeneration Systemscore 12.2 · 2 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 |
|---|---|---|---|
| * | K962774 | Osteomed QuickfixSummary page 4…IMF Fixation Screw and wire tion Name: 21CFR 872.4880: Intraosseous fixation screw or wire Code: DZL Predicate: d QUICK‐FIX, K962774 tion Name: 21CFR 872.4880: Intraosseous fixation screw or wire; Product Code: DZL; Class: II e Predicate: ve Bone Screw System,… | 1997 |
| * | K974785 | Auto-Drive Bone ScrewSummary page 4…DZL Predicate: d QUICK‐FIX, K962774 tion Name: 21CFR 872.4880: Intraosseous fixation screw or wire; Product Code: DZL; Class: II e Predicate: ve Bone Screw System, K974785 tion Name: 21CFR 888.3040, Smooth or threaded metallic fixation fastener, Product Code vice Class: II : escription: eoMed IC… | 1998 |
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 39 years and passes through 4 companies; a new generation was cleared every 17.5 years on median.
- 1 of the 14 ancestors has a recall of any class.
How does its category compare?
All DZL devicesDZL Screw, Fixation, Intraosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DZL
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZL
263in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZL
3in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZL
70in 2025
MAUDE reports naming product code DZL, 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 | 1 | — | 0 | 4 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 1 | 8 |
| 2010 | 3 | 89 | 1 | 17 |
| 2011 | 2 | — | 0 | 12 |
| 2012 | 0 | — | 0 | 236 |
| 2013 | 1 | — | 3 | 178 |
| 2014 | 2 | — | 0 | 106 |
| 2015 | 1 | — | 0 | 103 |
| 2016 | 1 | — | 0 | 34 |
| 2017 | 3 | 277 | 0 | 74 |
| 2018 | 0 | — | 0 | 57 |
| 2019 | 2 | — | 0 | 50 |
| 2020 | 1 | — | 0 | 85 |
| 2021 | 1 | — | 0 | 55 |
| 2022 | 0 | — | 0 | 162 |
| 2023 | 2 | — | 0 | 100 |
| 2024 | 2 | — | 0 | 106 |
| 2025 | 4 | 263 | 0 | 70 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The OsteoMed ICON IMF Screw System is intended and indicated for the temporary ligature and wire lock fixation for temporary constriction and stabilization of fracture bone segments in the oral cavity in conjunction with primary fixation devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151195 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151195: OsteoMed IMF Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151195
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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