510(k) · Cleared
Recalled · Class II · 2017Biomet Microfixation Facial Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Microfixation · JEY Plate, Bone
Cleared on Sep 21, 2012 as substantially equivalent to K953385 (Walter Lorenz Surgical, Inc., 1995) and 4 other predicates after a 113-day review. Its family tree reaches back 5 generations to 1976. 5 later devices descend from it. It has been recalled once.
- Decided
- Sep 21, 2012
- Review
- 113 days
- Class
- Class II
- Product code
- JEY
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 5 generations to K761228 (1976). 20 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK761228 Luhr Mandibular Compression-Screw SystemHowmedica Corp. · 1976
- 4 generations backK963739 Leibinger - Luhr Small Orthopedic Bone ScrewsHowmedica Leibinger, Inc. · 1997
- 3 generations backK970912 Leibinger Self-Drilling ScrewHowmedica Leibinger, Inc. · 1997
- 2 generations backK974785 Auto-Drive Bone ScrewOsteomed Corp. · 1998
- 1 generation backK013954 Lorenz Self Drilling ScrewsWalter Lorenz Surgical, Inc. · 2002
- This deviceK121589 Biomet Microfixation Facial Plating SystemBiomet Microfixation · 2012
- Descendant · cites it directly · 2 of its ownK140037 Optimus CMF SystemOsteonic Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK253373 Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty), Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK182609 Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE · 2019
- Descendant · 2 generations on · 0 of its ownK160363 Optimus CMF SystemOsteonic Co., Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK132600 Facial Prebent Plating with Virtual Surgical PlanningBiomet Microfixation · 2013
Most influential descendants
Showing 5 of 5 · See all- K140037Optimus CMF SystemOsteonic Co., Ltd. · 2015 · cites it directly2descendants
- K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty), Ltd. · 2025 · 2 generations on0descendants
- K182609Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE · 2019 · cites it directly0descendants
- K160363Optimus CMF SystemOsteonic Co., Ltd. · 2016 · 2 generations on0descendants
- K132600Facial Prebent Plating with Virtual Surgical PlanningBiomet Microfixation · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K761228 | Luhr Mandibular Compression-Screw System | Howmedica Corp. | 1976 | — |
| −4 | K963739 | Leibinger - Luhr Small Orthopedic Bone Screws | Howmedica Leibinger, Inc. | 1997 | — |
| −3 | K970912 | Leibinger Self-Drilling Screw | Howmedica Leibinger, Inc. | 1997 | — |
| −2 | K974785 | Auto-Drive Bone Screw | Osteomed Corp. | 1998 | — |
| −1 | K013954 | Lorenz Self Drilling Screws | Walter Lorenz Surgical, Inc. | 2002 | — |
| 0 (this device) | K121589 | Biomet Microfixation Facial Plating System | Biomet Microfixation | 2012 | — |
| +1 | K140037 | Optimus CMF System | Osteonic Co., Ltd. | 2015 | — |
| +2 | K253373 | Southern Craniomaxillofacial (CMF) System | Southern Medical (Pty), Ltd. | 2025 | — |
| +1 | K182609 | Delphos Implants Rigid Fixation System | Delphos Implants - Ind.Com. Importacao E Exportacao DE | 2019 | — |
| +2 | K160363 | Optimus CMF System | Osteonic Co., Ltd. | 2016 | — |
| +1 | K132600 | Facial Prebent Plating with Virtual Surgical Planning | Biomet Microfixation | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 3 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 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? (5)
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 |
|---|---|---|---|
| * | K953385 | Lorenz 1.0MM, 1.5MM, 2.0MM SystemSummary page 3…Facial Plating System modifications equivalent to the Biomet Microfixation's (formerly Walter Lorenz Surgical's) Lorenz 1.0mm, 1.5mm, 2.0mm Plating System cleared under K953385, Paulus Titanium Mini Bone Plates and Bone Screws cleared under K862534, Wuertzburg Plates and Screws cleared under K854886, Lore… | 1995 |
| * | K862534 | Paulus Titanium Mini Bone Plates & Bone ScrewsSummary page 3…ion's (formerly Walter Lorenz Surgical's) Lorenz 1.0mm, 1.5mm, 2.0mm Plating System cleared under K953385, Paulus Titanium Mini Bone Plates and Bone Screws cleared under K862534, Wuertzburg Plates and Screws cleared under K854886, Lorenz Self- Drilling Screw cleared under K01 3954, and Lorenz 1.0mmn System… | 1986 |
| * | K854886 | Wuerzburg Titanium Mini Bone Plates & Bone ScrewsSummary page 3…mm, 1.5mm, 2.0mm Plating System cleared under K953385, Paulus Titanium Mini Bone Plates and Bone Screws cleared under K862534, Wuertzburg Plates and Screws cleared under K854886, Lorenz Self- Drilling Screw cleared under K01 3954, and Lorenz 1.0mmn System cleared under K922741. In conclusion, the subject… | 1986 |
| * | K013954 | Lorenz Self Drilling ScrewsSummary page 3…85, Paulus Titanium Mini Bone Plates and Bone Screws cleared under K862534, Wuertzburg Plates and Screws cleared under K854886, Lorenz Self- Drilling Screw cleared under K01 3954, and Lorenz 1.0mmn System cleared under K922741. In conclusion, the subject Biomet Microfixation Facial Plating System devices h… | 2002 |
| * | K922741 | Lorenz 1.0 MM SystemSummary page 3…ews cleared under K862534, Wuertzburg Plates and Screws cleared under K854886, Lorenz Self- Drilling Screw cleared under K01 3954, and Lorenz 1.0mmn System cleared under K922741. In conclusion, the subject Biomet Microfixation Facial Plating System devices have the same intended use and similar technologi… | 1992 |
What descends from it? (5)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 10, 2017 | Class II | Z-1220-2017 | Under Investigation by firm | The identification of the devices was non-conforming with off-centered slots and the no-go gage starting in the pilot hole. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 36 years and passes through 5 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 20 ancestors have a recall of any class.
- Of its descendants, K140037 (Osteonic Co., Ltd., 2015) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K953385.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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?
These devices are implantable bone plates and bone screws for facial procedures including:
1. Fractures
2. Osteotomies
3. Reconstructive procedures
4. Revision procedures where other treatments or devices have failed
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121589 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121589: Biomet Microfixation Facial Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121589
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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