510(k) · Cleared
ClearedStoma Bone Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Storz AM Mark GmbH · DZL Screw, Fixation, Intraosseous
Cleared on Oct 27, 2005 as substantially equivalent to K961418 (Osteomed Corp., 1996) and 2 other predicates after a 108-day review. Its family tree reaches back 3 generations to 1982. 1 later device descends from it.
- Decided
- Oct 27, 2005
- Review
- 108 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K820944 (1982). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK820944 Dental Arch BarUnisplint Corp. · 1982
- 2 generations backK963030 Leibinger Imf ScrewHowmedica Leibinger, Inc. · 1997
- 1 generation backK980760 KLS-Martin MMF ScrewKLS-Martin L.P. · 1999
- This deviceK051871 Stoma Bone ScrewStorz AM Mark GmbH · 2005
- Descendant · cites it directly · 0 of its ownK132212 Dental Bone Screws; Dental Bone Screws, Continuing; Screw System TX…Hager& Meisinger GmbH · 2014
Most influential descendants
Showing 1 of 1 · See all- K132212Dental Bone Screws; Dental Bone Screws, Continuing; Screw System TX; Screw System TX…Hager& Meisinger GmbH · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K820944 | Dental Arch Bar | Unisplint Corp. | 1982 | — |
| −2 | K963030 | Leibinger Imf Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −1 | K980760 | KLS-Martin MMF Screw | KLS-Martin L.P. | 1999 | — |
| 0 (this device) | K051871 | Stoma Bone Screw | Storz AM Mark GmbH | 2005 | — |
| +1 | K132212 | Dental Bone Screws; Dental Bone Screws, Continuing; Screw System TX; Screw… | Hager& Meisinger GmbH | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K961418 | Osteomed MSSSummary page 2…stantial Equivalence Comparison STOMA Bone Screws are substantially equivalent to other legally marketed bone screws from dif- ferent manufacturers, e.g. OSTEOMED CORP. (K961418), KLS-Martin MMF Screw (K980760) and/or Synthes (USA) 1.3 Craniofacial Srews (K021850). 5. Biocompatibility All require… | 1996 |
| * | K980760 | KLS-Martin MMF ScrewSummary page 2…STOMA Bone Screws are substantially equivalent to other legally marketed bone screws from dif- ferent manufacturers, e.g. OSTEOMED CORP. (K961418), KLS-Martin MMF Screw (K980760) and/or Synthes (USA) 1.3 Craniofacial Srews (K021850). 5. Biocompatibility All requirements of biocompatibility are me… | 1999 |
| * | K021850 | Synthes (Usa) 1.3 MM Craniofacial ScrewsSummary page 2…r legally marketed bone screws from dif- ferent manufacturers, e.g. OSTEOMED CORP. (K961418), KLS-Martin MMF Screw (K980760) and/or Synthes (USA) 1.3 Craniofacial Srews (K021850). 5. Biocompatibility All requirements of biocompatibility are meet through the composition of the used material. The u… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132212 | Dental Bone Screws; Dental Bone Screws, Continuing; Screw System TX; Screw System TX… | 2014 | 0 |
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 23 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K132212 (Hager& Meisinger GmbH, 2014) has gone furthest, with 0 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?
STOMA Bone Screws are developed and manufactured to be used as non-active bone surgery implants for the treatment of bone fractures, especially for the fixation of transplanted bone blocks during the augmentation process and / or in combination with bone plates and bone meshes in the oral cavity and maxillomandibular surgical field.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051871 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051871: Stoma Bone Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051871
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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