510(k) · Cleared
ClearedBiosorbfx 1.5/2.0 Bioabsorbable 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 Sep 15, 1998 as substantially equivalent to K974554 (Synthes (Usa), 1998) and 5 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1990. 86 later devices descend from it.
- Decided
- Sep 15, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 3 generations to K904436 (1990). 19 ancestors in all. 86 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 2 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 1 generation backK972783 Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc. · 1998
- This deviceK982139 Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998
- Descendant · cites it directly · 79 of its ownK993061 Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999
- Descendant · cites it directly · 73 of its ownK011590 Resorb-X Resorbable Plating SystemKLS-Martin L.P. · 2002
- Descendant · 2 generations on · 65 of its ownK060177 KLS Martin Rigid Fixation - SterileKLS Martin L.P. · 2006
- Descendant · 3 generations on · 61 of its ownK070169 KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007
- Descendant · 4 generations on · 45 of its ownK151983 KLS Martin LSS Plating SystemKLS Martin L.P. · 2016
Showing 5 of 86 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 86 · See all- K993061Stryker Leibinger Resorbable Fixation SystemStryker Instruments · 1999 · cites it directly79descendants
- K011590Resorb-X Resorbable Plating SystemKLS-Martin L.P. · 2002 · cites it directly73descendants
- K060177KLS Martin Rigid Fixation - SterileKLS Martin L.P. · 2006 · 2 generations on65descendants
- K070169KLS Martin Quick Disc, Sternal Talon and Sternal Plating - SterileKLS Martin L.P. · 2007 · 3 generations on61descendants
- K151983KLS Martin LSS Plating SystemKLS Martin L.P. · 2016 · 4 generations on45descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −2 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −1 | K972783 | Biofix Biodegradable Threaded Suture Anchor | Bionx Implants, Inc. | 1998 | — |
| 0 (this device) | K982139 | Biosorbfx 1.5/2.0 Bioabsorbable Fixation System | Bionx Implants, Inc. | 1998 | — |
| +1 | K993061 | Stryker Leibinger Resorbable Fixation System | Stryker Instruments | 1999 | — |
| +1 | K011590 | Resorb-X Resorbable Plating System | KLS-Martin L.P. | 2002 | — |
| +2 | K060177 | KLS Martin Rigid Fixation - Sterile | KLS Martin L.P. | 2006 | — |
| +3 | K070169 | KLS Martin Quick Disc, Sternal Talon and Sternal Plating - Sterile | KLS Martin L.P. | 2007 | — |
| +4 | K151983 | KLS Martin LSS Plating System | KLS Martin L.P. | 2016 | — |
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 |
|---|---|---|
| 1999 | 2 | 0 |
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 10 | 0 |
| 2024 | 13 | 0 |
| 2025 | 15 | 0 |
| 2026 | 12 | 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? (6)
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 |
|---|---|---|---|
| * | K974554 | Synthes Resorbable Fixation SystemSummary page 1…iofacial Bone Plates and Plate Fasteners Classification Name Bone Plate (Product Code 76JEY) Predicate Devices (1) ) (3 4 Synthes, Inc. Resorbable Fixation System (K974554), Walter Lorenz Surgical, Inc. LactoSorb® Trauma Plating System (K974309, K971870, and K960988), Bionx BioSorb Endobrow Screw (K9… | 1998 |
| * | K974309 | Lactosorb PanelsSummary page 1…(Product Code 76JEY) Predicate Devices (1) ) (3 4 Synthes, Inc. Resorbable Fixation System (K974554), Walter Lorenz Surgical, Inc. LactoSorb® Trauma Plating System (K974309, K971870, and K960988), Bionx BioSorb Endobrow Screw (K972919), Bionx Biodegradable Threaded Suture Anchor (K972783) \\\DC - 63… | 1998 |
| * | K971870 | Lactosorb Trauma Plating SystemSummary page 1…Code 76JEY) Predicate Devices (1) ) (3 4 Synthes, Inc. Resorbable Fixation System (K974554), Walter Lorenz Surgical, Inc. LactoSorb® Trauma Plating System (K974309, K971870, and K960988), Bionx BioSorb Endobrow Screw (K972919), Bionx Biodegradable Threaded Suture Anchor (K972783) \\\DC - 63547/13 -… | 1997 |
| * | K960988 | Lactosorb Trauma Plating SystemSummary page 1…Predicate Devices (1) ) (3 4 Synthes, Inc. Resorbable Fixation System (K974554), Walter Lorenz Surgical, Inc. LactoSorb® Trauma Plating System (K974309, K971870, and K960988), Bionx BioSorb Endobrow Screw (K972919), Bionx Biodegradable Threaded Suture Anchor (K972783) \\\DC - 63547/13 - 0668113.01 =… | 1996 |
| * | K972919 | Biofix Bioabsorbable Self-Reinforced Poly-L-Lactide Threaded Browlift ScrewSummary page 1…, Inc. Resorbable Fixation System (K974554), Walter Lorenz Surgical, Inc. LactoSorb® Trauma Plating System (K974309, K971870, and K960988), Bionx BioSorb Endobrow Screw (K972919), Bionx Biodegradable Threaded Suture Anchor (K972783) \\\DC - 63547/13 - 0668113.01 Intended Use The BioSorbF… | 1998 |
| * | K972783 | Biofix Biodegradable Threaded Suture AnchorSummary page 1…enz Surgical, Inc. LactoSorb® Trauma Plating System (K974309, K971870, and K960988), Bionx BioSorb Endobrow Screw (K972919), Bionx Biodegradable Threaded Suture Anchor (K972783) \\\DC - 63547/13 - 0668113.01 Intended Use The BioSorbFX System is intended for use in trauma and reconstructi… | 1998 |
What descends from it? (86)
See all 865 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993061 | Stryker Leibinger Resorbable Fixation System | 1999 | 79 |
| K011590 | Resorb-X Resorbable Plating System | 2002 | 73 |
| K982721 | Biosorbfx 2.0/2.4 Orthognathic and Mandibular Fixation System | 1999 | 6 |
| K011569 | Biosorbfx O/M 2.0/2/4 System | 2002 | 5 |
| K042517 | Biosorb FX and Biosorb PDX 1.5 and 2.0 Screws | 2004 | 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 8 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K993061 (Stryker Instruments, 1999) has gone furthest, with 79 descendants of its own.
- 4 other devices also cite its predicate K974554.
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 System is intended for use in trauma and reconstructive procedures in the midface and craniofacial skeleton. Specifically, the device is indicated for use in treating comminuted fractures of the naseothmoidal and infraorbital areas; comminuted fractures of the frontal sinus wall; trauma of the midface and craniofacial skeleton, and reconstructive procedures of the midface or craniofacial skeleton. The BioSorbFX System is used to stabilize…
Read the full statement (129 words)
The BioSorbFX System is intended for use in trauma and reconstructive procedures in the midface and craniofacial skeleton. Specifically, the device is indicated for use in treating comminuted fractures of the naseothmoidal and infraorbital areas; comminuted fractures of the frontal sinus wall; trauma of the midface and craniofacial skeleton, and reconstructive procedures of the midface or craniofacial skeleton. The BioSorbFX System is used to stabilize bone during healing in conjunction with appropriate postoperative immobilization. The BioSorbFX System includes an instrumentation set containing bone drills, bone taps, screwdrivers and plate benders.
The BioSorbFX System is not intended for use in: 1) the mandible; 2) full load bearing procedures; 3) areas with active infection; or 4) patient conditions, including blood supply limitations, insufficient quantity or quality of bone, or latent infections.
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/K982139 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982139: Biosorbfx 1.5/2.0 Bioabsorbable Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982139
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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