510(k) · Cleared
ClearedCodman Craniosorb Absorbable Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Codman & Shurtleff, Inc. · JEY Plate, Bone
Cleared on Aug 1, 2000 as substantially equivalent to K971870 (Biomet, Inc., 1997) and 1 other predicate after a 337-day review. Its family tree reaches back 2 generations to 1990. 3 later devices descend from it.
- Decided
- Aug 1, 2000
- Review
- 337 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K900138 (1990). 6 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK900138 Motech Titanium Surgical MeshBiedermann Motech GmbH · 1990
- 1 generation backK972913 Macropore Protective Sheet (Protego System)Pacific Materials and Interfaces · 1998
- This deviceK992905 Codman Craniosorb Absorbable Fixation SystemCodman & Shurtleff, Inc. · 2000
- Descendant · cites it directly · 2 of its ownK073006 Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2008
- Descendant · 2 generations on · 0 of its ownK121606 Resorb-X GKLS-Martin L.P. · 2013
- Descendant · 2 generations on · 0 of its ownK101835 Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc. · 2010
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K900138 | Motech Titanium Surgical Mesh | Biedermann Motech GmbH | 1990 | — |
| −1 | K972913 | Macropore Protective Sheet (Protego System) | Pacific Materials and Interfaces | 1998 | — |
| 0 (this device) | K992905 | Codman Craniosorb Absorbable Fixation System | Codman & Shurtleff, Inc. | 2000 | — |
| +1 | K073006 | Osteotrans -MX Bioabsorbable Bone Fixation System | Takiron Co., Ltd. | 2008 | — |
| +2 | K121606 | Resorb-X G | KLS-Martin L.P. | 2013 | — |
| +2 | K101835 | Medpor Fixation System-Cranial, Models 80080, 80079 | Porex Surgical, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 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 JEY? 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 JEY device
- #1 K252246 Leforte MMF Systemscore 15.6 · 16 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 1…GXR). Statement of Substantial Equivalence The CODMAN® CRANIOSORB™ Absorbable Fixation System is substantially equivalent to both the LactoSorb® Trauma Plating System (K971870) and the MacroPore Protective Sheet (K972913) based on the subject device’s similarity to the predicate devices in intended use,… | 1997 |
| * | K972913 | Macropore Protective Sheet (Protego System)Summary page 1…The CODMAN® CRANIOSORB™ Absorbable Fixation System is substantially equivalent to both the LactoSorb® Trauma Plating System (K971870) and the MacroPore Protective Sheet (K972913) based on the subject device’s similarity to the predicate devices in intended use, materials, design, and principles of operatio… | 1998 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073006 | Osteotrans -MX Bioabsorbable Bone Fixation System | 2008 | 2 |
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 10 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K073006 (Takiron Co., Ltd., 2008) has gone furthest, with 2 descendants of its own.
- 10 other devices also cite its predicate K971870.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JEY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JEY
159in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JEY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEY
1,003in 2025
MAUDE reports naming product code JEY, 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 | 9 | 115 | 0 | 29 |
| 2008 | 7 | 84 | 3 | 24 |
| 2009 | 4 | 121 | 6 | 93 |
| 2010 | 6 | 199 | 85 | 215 |
| 2011 | 5 | 75 | 0 | 241 |
| 2012 | 10 | 194 | 0 | 428 |
| 2013 | 8 | 126 | 1 | 766 |
| 2014 | 6 | 223 | 0 | 616 |
| 2015 | 7 | 160 | 0 | 767 |
| 2016 | 1 | — | 0 | 558 |
| 2017 | 5 | 190 | 0 | 568 |
| 2018 | 7 | 255 | 0 | 608 |
| 2019 | 6 | 163 | 0 | 595 |
| 2020 | 6 | 198 | 1 | 680 |
| 2021 | 4 | 299 | 0 | 451 |
| 2022 | 5 | 135 | 0 | 344 |
| 2023 | 2 | — | 0 | 495 |
| 2024 | 5 | 159 | 0 | 696 |
| 2025 | 2 | — | 0 | 1,003 |
| 2026 | 3 | 258 | 0 | — |
What is it indicated for?
The CODMAN® CRANIOSORB™ Absorbable Fixation System is intended for surgical procedures in which internal fixation is required to align and stabilize bony tissue for craniofacial skeletal reconstruction and the repair of traumatic fractures of the craniofacial skeleton.
The CODMAN® CRANIOSORB™ Absorbable Fixation System is contraindicated for use in the mandible and as a primary source of fixation in weight bearing areas.
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/K992905 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992905: Codman Craniosorb Absorbable 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/K992905
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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