510(k) · Cleared
ClearedBiosorbfx 2.0/2.4 Orthognathic and Mandibular Fixation 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 17, 1999 as substantially equivalent to K971870 (Biomet, Inc., 1997) and 1 other predicate after a 197-day review. Its family tree reaches back 4 generations to 1990. 6 later devices descend from it.
- Decided
- Feb 17, 1999
- Review
- 197 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K904436 (1990). 20 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 3 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 2 generations backK972783 Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc. · 1998
- 1 generation backK982139 Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998
- This deviceK982721 Biosorbfx 2.0/2.4 Orthognathic and Mandibular Fixation SystemBionx Implants, Inc. · 1999
- Descendant · cites it directly · 5 of its ownK011569 Biosorbfx O/M 2.0/2/4 SystemBionx Implants, Inc. · 2002
- Descendant · 2 generations on · 3 of its ownK061881 Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2007
- Descendant · 3 generations on · 2 of its ownK073006 Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2008
- Descendant · 4 generations on · 0 of its ownK121606 Resorb-X GKLS-Martin L.P. · 2013
- Descendant · 4 generations on · 0 of its ownK101835 Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc. · 2010
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K011569Biosorbfx O/M 2.0/2/4 SystemBionx Implants, Inc. · 2002 · cites it directly5descendants
- K061881Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2007 · 2 generations on3descendants
- K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2008 · 3 generations on2descendants
- K121606Resorb-X GKLS-Martin L.P. · 2013 · 4 generations on0descendants
- K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc. · 2010 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −3 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −2 | K972783 | Biofix Biodegradable Threaded Suture Anchor | Bionx Implants, Inc. | 1998 | — |
| −1 | K982139 | Biosorbfx 1.5/2.0 Bioabsorbable Fixation System | Bionx Implants, Inc. | 1998 | — |
| 0 (this device) | K982721 | Biosorbfx 2.0/2.4 Orthognathic and Mandibular Fixation System | Bionx Implants, Inc. | 1999 | — |
| +1 | K011569 | Biosorbfx O/M 2.0/2/4 System | Bionx Implants, Inc. | 2002 | — |
| +2 | K061881 | Osteotrans -MX Bioabsorbable Bone Fixation System | Takiron Co., Ltd. | 2007 | — |
| +3 | K073006 | Osteotrans -MX Bioabsorbable Bone Fixation System | Takiron Co., Ltd. | 2008 | — |
| +4 | K121606 | Resorb-X G | KLS-Martin L.P. | 2013 | — |
| +4 | 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 |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 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? (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…ME: BioSorbFX 2.0/2.4 Orthognathic Bioabsorbable Fixation System COMMON NAME: Bone Plates and Bone Screws PRODUCT TO WHICH COMPARED: LactoSorb® Trauma Plating System (K971870) (510 (k) NUMBER IF KNOWN) BioSorbFX 1.5/2.0 Bioabsorbable Fixation System (K982139) YES 1. IS PRODUCT A DEVICE? X 2. DEVICE SU… | 1997 |
| * | K982139 | Biosorbfx 1.5/2.0 Bioabsorbable Fixation System Cleared while this submission was under review Summary page 1…Plates and Bone Screws PRODUCT TO WHICH COMPARED: LactoSorb® Trauma Plating System (K971870) (510 (k) NUMBER IF KNOWN) BioSorbFX 1.5/2.0 Bioabsorbable Fixation System (K982139) YES 1. IS PRODUCT A DEVICE? X 2. DEVICE SUBJECT TO 510(k)? X 3. SAME INDICATION STATEMENT? X 4. DO DIFFERENCES ALTER THE EFFECT… | 1998 |
| † | K972783 | Biofix Biodegradable Threaded Suture Anchor | 1998 |
| † | K972919 | Biofix Bioabsorbable Self-Reinforced Poly-L-Lactide Threaded Browlift Screw | 1998 |
What descends from it? (6)
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 9 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 20 ancestors has a recall of any class.
- Of its descendants, K011569 (Bionx Implants, Inc., 2002) has gone furthest, with 5 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 BioSorbFX 2.0/2.4 Bioabsorbable Fixation System (“BioSorbFX 2.0/2.4 System”) is intended for use in trauma and reconstructive procedures in the midface and maxilla. Specifically, the device is indicated for use in surgical repair procedures in the treatment of trauma to the midface and maxilla, and in orthognathic and reconstructive procedures of the midface or maxilla. An instrumentation set which is used to implant the fasteners to secure the plates to bone is included with the BioSorbFX 2.0/2.4 System. The BioSorbFX 2.0/2.4 System is not intended for use in mandibular applications.
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/K982721 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982721: Biosorbfx 2.0/2.4 Orthognathic and Mandibular 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/K982721
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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