510(k) · Cleared
Cleared2.5 MM Lactosorb Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · DZL Screw, Fixation, Intraosseous
Cleared on Nov 3, 1998 after a 176-day review. The FDA summary names no predicate by number. 9 later devices descend from it.
- Decided
- Nov 3, 1998
- Review
- 176 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK981666 2.5 MM Lactosorb ScrewsBiomet, Inc. · 1998
- Descendant · cites it directly · 5 of its ownK011569 Biosorbfx O/M 2.0/2/4 SystemBionx Implants, Inc. · 2002
- Descendant · 2 generations on · 3 of its ownK061881 Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2007
- Descendant · 3 generations on · 2 of its ownK073006 Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2008
- Descendant · cites it directly · 1 of its ownK030425 Lorenz Resorbable Distraction System or ExpanderWalter Lorenz Surgical, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK133304 RXG Distraction SystemKLS-Martin L.P. · 2014
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K011569Biosorbfx O/M 2.0/2/4 SystemBionx Implants, Inc. · 2002 · cites it directly5descendants
- K061881Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2007 · 2 generations on3descendants
- K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2008 · 3 generations on2descendants
- K030425Lorenz Resorbable Distraction System or ExpanderWalter Lorenz Surgical, Inc. · 2004 · cites it directly1descendant
- K133304RXG Distraction SystemKLS-Martin L.P. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981666 | 2.5 MM Lactosorb Screws | Biomet, Inc. | 1998 | — |
| +1 | K011569 | Biosorbfx O/M 2.0/2/4 System | Bionx Implants, Inc. | 2002 | — |
| +2 | K061881 | Osteotrans -MX Bioabsorbable Bone Fixation System | Takiron Co., Ltd. | 2007 | — |
| +3 | K073006 | Osteotrans -MX Bioabsorbable Bone Fixation System | Takiron Co., Ltd. | 2008 | — |
| +1 | K030425 | Lorenz Resorbable Distraction System or Expander | Walter Lorenz Surgical, Inc. | 2004 | — |
| +2 | K133304 | RXG Distraction System | KLS-Martin L.P. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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 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?
The FDA summary names no predicate by number.
What descends from it? (9)
3 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, K011569 (Bionx Implants, Inc., 2002) has gone furthest, with 5 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 | — |
What is it indicated for?
The 2.5mm LactoSorb Screws are indicated for use as fixation in mandibular osteotomy procedures, including but not limited to:
1. sagittal split osteotomy
2. vertical ramus osteotomy
3. inferior border osteotomy
4. subapical osteotomy
5. genioplasty
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/K981666 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981666: 2.5 MM Lactosorb Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981666
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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