510(k) · Cleared
ClearedLuhr Mandibular Compression-Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Corp. · DZL Screw, Fixation, Intraosseous
Cleared on Dec 15, 1976 after a 5-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 190 later devices descend from it.
- Decided
- Dec 15, 1976
- Review
- 5 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 0
190 later devices descend from it, 2 citing it directly.
- This deviceK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- Descendant · cites it directly · 188 of its ownK963741 Leibinger Luhr Small Craniomaxillofacial Bone ScrewsHowmedica Leibinger, Inc. · 1997
- Descendant · cites it directly · 144 of its ownK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- Descendant · 2 generations on · 143 of its ownK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- Descendant · 3 generations on · 141 of its ownK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- Descendant · 4 generations on · 117 of its ownK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
Showing 5 of 190 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 190 · See all- K963741Leibinger Luhr Small Craniomaxillofacial Bone ScrewsHowmedica Leibinger, Inc. · 1997 · cites it directly188descendants
- K963739Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997 · cites it directly144descendants
- K970912Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997 · 2 generations on143descendants
- K974785Auto-Drive Bone ScrewOsteomed Corp. · 1998 · 3 generations on141descendants
- K013954Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002 · 4 generations on117descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| +1 | K963741 | Leibinger Luhr Small Craniomaxillofacial Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| +1 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| +2 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| +3 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| +4 | K013954 | Lorenz Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 6 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 11 | 0 |
| 2013 | 7 | 0 |
| 2014 | 8 | 0 |
| 2015 | 11 | 0 |
| 2016 | 10 | 0 |
| 2017 | 2 | 0 |
| 2018 | 10 | 0 |
| 2019 | 7 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 8 | 0 |
| 2023 | 13 | 0 |
| 2024 | 23 | 0 |
| 2025 | 17 | 0 |
| 2026 | 18 | 0 |
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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (190)
See all 1902 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?
- Of its descendants, K963741 (Howmedica Leibinger, Inc., 1997) has gone furthest, with 188 descendants of its own.
How does its category compare?
All DZL devicesDZL Screw, Fixation, Intraosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K761228 · printed Nov 4, 2026
Cite this page
510(k) Report. “K761228: Luhr Mandibular Compression-Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K761228
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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