510(k) · Cleared
ClearedOsteomed Bioresorbable Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed Corp. · DZL Screw, Fixation, Intraosseous
Cleared on Jan 16, 2002 as substantially equivalent to K972913 (Pacific Materials and Interfaces, 1998) and 2 other predicates after a 167-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Jan 16, 2002
- Review
- 167 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K904436 (1990). 25 ancestors in all, the oldest K900138 (1990). No later device cites it as a predicate yet.
- Root · 5 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 4 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 3 generations backK972783 Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc. · 1998
- 2 generations backK982139 Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998
- 1 generation backK993061 Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999
- This deviceK012486 Osteomed Bioresorbable Fixation SystemOsteomed Corp. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −4 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −3 | K972783 | Biofix Biodegradable Threaded Suture Anchor | Bionx Implants, Inc. | 1998 | — |
| −2 | K982139 | Biosorbfx 1.5/2.0 Bioabsorbable Fixation System | Bionx Implants, Inc. | 1998 | — |
| −1 | K993061 | Stryker Leibinger Resorbable Fixation System | Stryker Instruments | 1999 | — |
| 0 (this device) | K012486 | Osteomed Bioresorbable Fixation System | Osteomed Corp. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 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 |
|---|---|---|---|
| * | K972913 | Macropore Protective Sheet (Protego System)Summary page 1…poly L/D,L-lactide. Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Macropore Protective Sheet (K972913), the Synthes Resorbable Fixation System (K974554) and the Stryker Leibinger Resorbable Fixation System (K993061). Due to the si… | 1998 |
| * | K974554 | Synthes Resorbable Fixation SystemSummary page 1…is based on similarities in intended use, material, design and operational principle to the Macropore Protective Sheet (K972913), the Synthes Resorbable Fixation System (K974554) and the Stryker Leibinger Resorbable Fixation System (K993061). Due to the similarity of materials and design to both pre-enact… | 1998 |
| * | K993061 | Stryker Leibinger Resorbable Fixation SystemSummary page 1…operational principle to the Macropore Protective Sheet (K972913), the Synthes Resorbable Fixation System (K974554) and the Stryker Leibinger Resorbable Fixation System (K993061). Due to the similarity of materials and design to both pre-enactment and post- enactment devices, OsteoMed believes that the Os… | 1999 |
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 12 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 25 ancestors has a recall of any class.
- 4 other devices also cite its predicate K972913.
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?
Indicated for use in trauma and reconstructive procedures in the midface and craniofacial skeleton, including, but not limited to, comminuted fractures of the nasoethmoidal and infraorbital areas, comminuted fractures of the frontal sinus wall and midfacial fractures, and reconstructive procedures of the midface or craniofacial skeleton. The OsteoMed Bioresorbable Fixation System is not intended for use in and is contraindicated for: the mandible and/or…
Read the full statement (119 words)
Indicated for use in trauma and reconstructive procedures in the midface and craniofacial skeleton, including, but not limited to, comminuted fractures of the nasoethmoidal and infraorbital areas, comminuted fractures of the frontal sinus wall and midfacial fractures, and reconstructive procedures of the midface or craniofacial skeleton.
The OsteoMed Bioresorbable Fixation System is not intended for use in and is contraindicated for: the mandible and/or full load bearing procedures; in cases of active or suspected infection or in patients who are immunocompromised; in cases where there is limitation of the blood supply or inadequate volume or quality of bone to place the system securely, in patients exhibiting disorders which would cause the patient to ignore the limitations of rigid fixation.
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/K012486 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012486: Osteomed Bioresorbable Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012486
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026