510(k) · Cleared
ClearedLorenz 1.5 X 4 MM Lactosorb Tap Free Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Walter Lorenz Surgical, Inc. · DZL Screw, Fixation, Intraosseous
Cleared on May 21, 2002 as substantially equivalent to K971870 (Biomet, Inc., 1997) and 1 other predicate after an 11-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- May 21, 2002
- Review
- 11 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K971870 (1997). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK971870 Lactosorb Trauma Plating SystemBiomet, Inc. · 1997
- This deviceK021522 Lorenz 1.5 X 4 MM Lactosorb Tap Free ScrewWalter Lorenz Surgical, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971870 | Lactosorb Trauma Plating System | Biomet, Inc. | 1997 | — |
| 0 (this device) | K021522 | Lorenz 1.5 X 4 MM Lactosorb Tap Free Screw | Walter Lorenz Surgical, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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? (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 |
|---|---|---|---|
| * | K971870 | Lactosorb Trauma Plating SystemSummary page 2…iameter. The head geometry, drive mechanism, major diameter, and tip geometry of the 1.5 x 4 mm Tap Free Screw is identical to that of the 1.5 x 4 mm Direct Drive Screw (K971870). The only difference between the two screws is the “thread” form. Although the tap free screws are similar in design to the sta… | 1997 |
| * | K002423 | Lactosorb Push ScrewSummary page 2…form. Although the tap free screws are similar in design to the standard Lactosorb® direct drive screws (K971870), they function thore like the Lactosorb® Push Screws (K002423). The push screws are designed with barbs that are pushed into a drilled hole that is slightly smaller than the diameter around t… | 2000 |
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?
- None of the 2 ancestors has a recall.
- 10 other devices also cite its predicate K971870.
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 Lactosorb® Tap Free Screw is indicated for use in the following midface and craniofacial procedures. A. General Indication: trauma procedures of the midface or craniofacial skeleton Specific Indications: Comminuted fractures of the naso-ethmoidal infraorbital areas Comminuted fractures of the frontal sinus wall Pediatric midface or craniofacial trauma LeFort (I, II, III) fractures Orbital floor fractures Fractures of the maxilla, zygoma, zygomatic…
Read the full statement (161 words)
The Lactosorb® Tap Free Screw is indicated for use in the following midface and craniofacial procedures.
A. General Indication: trauma procedures of the midface or craniofacial skeleton
Specific Indications:
Comminuted fractures of the naso-ethmoidal infraorbital areas
Comminuted fractures of the frontal sinus wall
Pediatric midface or craniofacial trauma
LeFort (I, II, III) fractures
Orbital floor fractures
Fractures of the maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones.
Trauma of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones.
B. General Indication: reconstructive procedures of the midface or craniofacial skeleton
Specific Indications:
Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma, etc.)
LeFort (I, II, III) osteotomies
Tumor reconstruction in midface or craniofacial procedures
Bone graft procedures in the midface or craniofacial skeleton
Pediatric reconstructive procedures
Reconstructive procedures of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones
Craniotomy flap fixation
This system is not designed for use in the mandible and/or full load bearing procedures.
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/K021522 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021522: Lorenz 1.5 X 4 MM Lactosorb Tap Free Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021522
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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