510(k) · Cleared
ClearedBiosorb FX and Biosorb PDX 1.5 and 2.0 Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linvatec Biomaterials, Ltd. · JEY Plate, Bone
Cleared on Oct 8, 2004 as substantially equivalent to K982139 (Bionx Implants, Inc., 1998) and 3 other predicates after a 23-day review. Its family tree reaches back 6 generations to 1990.
- Decided
- Oct 8, 2004
- Review
- 23 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K904436 (1990). 32 ancestors in all, the oldest K862532 (1986). No later device cites it as a predicate yet.
- Root · 6 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 5 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 4 generations backK972783 Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc. · 1998
- 3 generations backK982139 Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998
- 2 generations backK982721 Biosorbfx 2.0/2.4 Orthognathic and Mandibular Fixation SystemBionx Implants, Inc. · 1999
- 1 generation backK011569 Biosorbfx O/M 2.0/2/4 SystemBionx Implants, Inc. · 2002
- This deviceK042517 Biosorb FX and Biosorb PDX 1.5 and 2.0 ScrewsLinvatec Biomaterials, Ltd. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −5 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −4 | K972783 | Biofix Biodegradable Threaded Suture Anchor | Bionx Implants, Inc. | 1998 | — |
| −3 | K982139 | Biosorbfx 1.5/2.0 Bioabsorbable Fixation System | Bionx Implants, Inc. | 1998 | — |
| −2 | 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 | — |
| 0 (this device) | 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 | 2 | 0 |
| 2001 | 2 | 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? (4)
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…(the previous Bionx Implants) diameter 1.5mm and 2.0mm screw type fasteners, which are used with bioabsorbable plates of the same products families BioSorbTM FX 1.5/2.0 (K982139), BioSorb TM FX 2.0/2.4 O/M (K982721, KO1 1569) and BioSorbTM PDX (K000836). Originally the screw head design of 0 1.5 and 2.0mm… | 1998 |
| * | K982721 | Biosorbfx 2.0/2.4 Orthognathic and Mandibular Fixation SystemSummary page 1…r 1.5mm and 2.0mm screw type fasteners, which are used with bioabsorbable plates of the same products families BioSorbTM FX 1.5/2.0 (K982139), BioSorb TM FX 2.0/2.4 O/M (K982721, KO1 1569) and BioSorbTM PDX (K000836). Originally the screw head design of 0 1.5 and 2.0mm screw models of BioSorbTM FX and Bio… | 1999 |
| * | K011569 | Biosorbfx O/M 2.0/2/4 System | 2002 |
| * | K000836 | Biosorbpdx Bioabsorbable Fixation SystemSummary page 1…, which are used with bioabsorbable plates of the same products families BioSorbTM FX 1.5/2.0 (K982139), BioSorb TM FX 2.0/2.4 O/M (K982721, KO1 1569) and BioSorbTM PDX (K000836). Originally the screw head design of 0 1.5 and 2.0mm screw models of BioSorbTM FX and BioSorbTM PDX product families was design… | 2000 |
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 14 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 3 of the 32 ancestors have a recall of any class.
- 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?
O 1.5 and 2.0mm screw models of BioSorbTM FX and BioSorbTM PDX are used for plate fixation fasteners in trauma and constructive procedures in the midface and craniofacial skeleton. Specifically, the device is indicated for use in treating fractures of the craniofacial skeleton, including, but not limited to, comminuted fractures of the nasoethmoidal and infraorbital areas; comminuted fractures of the frontal sinus wall; orbital floor fractures; trauma of…
Read the full statement (132 words)
O 1.5 and 2.0mm screw models of BioSorbTM FX and BioSorbTM PDX are used for plate fixation fasteners in trauma and constructive procedures in the midface and craniofacial skeleton. Specifically, the device is indicated for use in treating fractures of the craniofacial skeleton, including, but not limited to, comminuted fractures of the nasoethmoidal and infraorbital areas; comminuted fractures of the frontal sinus wall; orbital floor fractures; trauma of the midface or craniofacial skeleton and reconstructive procedures of the midface or craniofacial skeleton.
O 2.0 mm screw models of BioSorbTM FX can be used for plate fixation fasteners with BioSorbTM FX 2.0/2.4 O/M plates in trauma and reconstructive procedures in the midface, maxilla and mandible. Especially in mandible BioSorbTM FX 2.0/2.4 O/M System must be used in conjunction of appropriate maxillomandibular fixation (MMF).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042517 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042517: Biosorb FX and Biosorb PDX 1.5 and 2.0 Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042517
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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