510(k) · Cleared
ClearedBiosorbfx O/M 2.0/2/4 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionx Implants, Inc. · JEY Plate, Bone
Cleared on Feb 22, 2002 as substantially equivalent to K982139 (Bionx Implants, Inc., 1998) and 7 other predicates after a 277-day review. Its family tree reaches back 5 generations to 1990. 5 later devices descend from it.
- Decided
- Feb 22, 2002
- Review
- 277 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 5 generations to K904436 (1990). 30 ancestors in all, the oldest K862532 (1986). 5 later devices descend from it, 2 citing it directly.
- 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 backK982721 Biosorbfx 2.0/2.4 Orthognathic and Mandibular Fixation SystemBionx Implants, Inc. · 1999
- This deviceK011569 Biosorbfx O/M 2.0/2/4 SystemBionx Implants, Inc. · 2002
- Descendant · cites it directly · 3 of its ownK061881 Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2007
- Descendant · 2 generations on · 2 of its ownK073006 Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2008
- Descendant · 3 generations on · 0 of its ownK121606 Resorb-X GKLS-Martin L.P. · 2013
- Descendant · 3 generations on · 0 of its ownK101835 Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK042517 Biosorb FX and Biosorb PDX 1.5 and 2.0 ScrewsLinvatec Biomaterials, Ltd. · 2004
Most influential descendants
Showing 5 of 5 · See all- K061881Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2007 · cites it directly3descendants
- K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2008 · 2 generations on2descendants
- K121606Resorb-X GKLS-Martin L.P. · 2013 · 3 generations on0descendants
- K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc. · 2010 · 3 generations on0descendants
- K042517Biosorb FX and Biosorb PDX 1.5 and 2.0 ScrewsLinvatec Biomaterials, Ltd. · 2004 · cites it directly0descendants
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 | K982721 | Biosorbfx 2.0/2.4 Orthognathic and Mandibular Fixation System | Bionx Implants, Inc. | 1999 | — |
| 0 (this device) | K011569 | Biosorbfx O/M 2.0/2/4 System | Bionx Implants, Inc. | 2002 | — |
| +1 | K061881 | Osteotrans -MX Bioabsorbable Bone Fixation System | Takiron Co., Ltd. | 2007 | — |
| +2 | K073006 | Osteotrans -MX Bioabsorbable Bone Fixation System | Takiron Co., Ltd. | 2008 | — |
| +3 | K121606 | Resorb-X G | KLS-Martin L.P. | 2013 | — |
| +3 | K101835 | Medpor Fixation System-Cranial, Models 80080, 80079 | Porex Surgical, Inc. | 2010 | — |
| +1 | K042517 | Biosorb FX and Biosorb PDX 1.5 and 2.0 Screws | Linvatec Biomaterials, Ltd. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 6 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 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? (8)
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 |
|---|---|---|---|
| * | K982139 | Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemSummary page 1…Plate and fasteners (Product Code 76 JEY) Predicate Devices: 1. 'Bionx Implants, Inc. BioSorbFX' 1.5/2.0 Bioabsorbable Fixation! System (“BioSorbFX™ 1.5/2.0 Systern™) (K982139) l{ 1 2. Bionx Implants, Inc. BioSorbFX™ O/M 2.0/2.4 Bioabsorbable Fixation System (“BioSorbFX™ O/M 2.0/2.4 System™) (K982721) 3.… | 1998 |
| * | K982721 | Biosorbfx 2.0/2.4 Orthognathic and Mandibular Fixation SystemSummary page 1…ion! System (“BioSorbFX™ 1.5/2.0 Systern™) (K982139) l{ 1 2. Bionx Implants, Inc. BioSorbFX™ O/M 2.0/2.4 Bioabsorbable Fixation System (“BioSorbFX™ O/M 2.0/2.4 System™) (K982721) 3. Biomet Inc. 2.5mm LactoSorb® Screws (K981666) 4. Biomet Inc. LactoSorb® Sheets (K992158) 5.1 Synthes SMF Resorbuble Meshes an… | 1999 |
| * | K981666 | 2.5 MM Lactosorb ScrewsSummary page 1…39) l{ 1 2. Bionx Implants, Inc. BioSorbFX™ O/M 2.0/2.4 Bioabsorbable Fixation System (“BioSorbFX™ O/M 2.0/2.4 System™) (K982721) 3. Biomet Inc. 2.5mm LactoSorb® Screws (K981666) 4. Biomet Inc. LactoSorb® Sheets (K992158) 5.1 Synthes SMF Resorbuble Meshes and Sheets (K003786) 6. Lorenz Resorbable Distracto… | 1998 |
| * | K992158 | Lactosorb SheetsSummary page 1…O/M 2.0/2.4 Bioabsorbable Fixation System (“BioSorbFX™ O/M 2.0/2.4 System™) (K982721) 3. Biomet Inc. 2.5mm LactoSorb® Screws (K981666) 4. Biomet Inc. LactoSorb® Sheets (K992158) 5.1 Synthes SMF Resorbuble Meshes and Sheets (K003786) 6. Lorenz Resorbable Distractor System (K002083) 7. Macropore MacroporeMX… | 1999 |
| * | K003786 | SMF Resorbable Meshes and SheetsSummary page 1…O/M 2.0/2.4 System™) (K982721) 3. Biomet Inc. 2.5mm LactoSorb® Screws (K981666) 4. Biomet Inc. LactoSorb® Sheets (K992158) 5.1 Synthes SMF Resorbuble Meshes and Sheets (K003786) 6. Lorenz Resorbable Distractor System (K002083) 7. Macropore MacroporeMX Mandibular Fixation System (K000696) 8… | 2001 |
| * | K002083 | Lorenz Resorbable Distractor SystemSummary page 1…5mm LactoSorb® Screws (K981666) 4. Biomet Inc. LactoSorb® Sheets (K992158) 5.1 Synthes SMF Resorbuble Meshes and Sheets (K003786) 6. Lorenz Resorbable Distractor System (K002083) 7. Macropore MacroporeMX Mandibular Fixation System (K000696) 8. Macropore Protective Sheet (K983360) Intended… | 2001 |
| * | K000696 | Macroporemx Mandibular Fixation SystemSummary page 1…ts (K992158) 5.1 Synthes SMF Resorbuble Meshes and Sheets (K003786) 6. Lorenz Resorbable Distractor System (K002083) 7. Macropore MacroporeMX Mandibular Fixation System (K000696) 8. Macropore Protective Sheet (K983360) Intended Use i The BioSotbFX O/M 2.0/2.4 System is intended for use in… | 2000 |
| * | K983360 | Macropore Protective SheetSummary page 2…s (K003786) 6. Lorenz Resorbable Distractor System (K002083) 7. Macropore MacroporeMX Mandibular Fixation System (K000696) 8. Macropore Protective Sheet (K983360) Intended Use i The BioSotbFX O/M 2.0/2.4 System is intended for use in traum: and recopstructive procedures in the midface, max… | 1999 |
| † | K972919 | Biofix Bioabsorbable Self-Reinforced Poly-L-Lactide Threaded Browlift Screw | 1998 |
What descends from it? (5)
2 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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 30 ancestors have a recall of any class.
- Of its descendants, K061881 (Takiron Co., Ltd., 2007) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K982139.
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 BioSotbFX O/M 2i0/2.4 System is intended for usc in trauma and recorstructive procedures in the midface, maxilla and mandible. Specifically, the device is indicated for use in surgical repair procedures in the treatment of traurna to the midfac { maxilla and mandible, and in orthognathic and reconstructive procedures of the mnidface, maxilla or wandible. The BioSorbFX O/M 2.0/2.4 System stabilizes borfe during healing, in conjunction with appropriate…
Read the full statement (162 words)
The BioSotbFX O/M 2i0/2.4 System is intended for usc in trauma and recorstructive procedures in the midface, maxilla and mandible. Specifically, the device is indicated for use in surgical repair procedures in the treatment of traurna to the midfac { maxilla and mandible, and in orthognathic and reconstructive procedures of the mnidface, maxilla or wandible. The BioSorbFX O/M 2.0/2.4 System stabilizes borfe during healing, in conjunction with appropriate postoperative immobiliz:tion. Especially in mandible BioSorbFX O/M System must be used in comjunction of ap‘?ropriatc maxillomandibular fixation (MMF).
The BioSorbFX O/M 2.0/2.4 System implants are not intended for use in, and are contraindicated for:
1. Mandibular tumor resection.
2. Simations where internal fixation is otherwise contraindicated e.g., active or potential infection; patient conditions, including blood supply limitations, insufficicnt quantity or quality of bone; and where patient co-operation cannot be guaranteed (e.g., alcoholism).
3. Significant comminuted fractures, including significant bone loss,i of the mandible.
4. Jotermaxillary fixation without an appropriate extemal fixation by other means.
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/K011569 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011569: Biosorbfx O/M 2.0/2/4 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011569
Report an extraction error
Are you the manufacturer?
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