510(k) · Cleared
ClearedBiodrive Micro Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ebi,Llc D/B/A Biomet Trauma · HRS Plate, Fixation, Bone
Cleared on Nov 19, 2009 as substantially equivalent to K050681 (TriMed, Inc., 2005) and 2 other predicates after an 80-day review. Its family tree reaches back 5 generations to 1992. 68 later devices descend from it.
- Decided
- Nov 19, 2009
- Review
- 80 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K915818 (1992). 28 ancestors in all, the oldest K792022 (1979). 68 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK915818 Synthes (R) Titanium Small Reconstruction PlateSynthes (Usa) · 1992 · Recalled
- 4 generations backK990094 Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 1999
- 3 generations backK991873 Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 1999
- 2 generations backK021321 Wrist Fusion PlateAcu Med, Inc. · 2002
- 1 generation backK050681 Omnitech System & Easy Lock Osteosystem with Xtremities PlatesTriMed, Inc. · 2005
- This deviceK092670 Biodrive Micro Screw SystemEbi,Llc D/B/A Biomet Trauma · 2009
- Descendant · cites it directly · 58 of its ownK111678 Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · Recalled
- Descendant · 2 generations on · 28 of its ownK141784 Ortho Solutions Ultos Plating SystemOrtho Solutions Limited · 2014 · Recalled
- Descendant · cites it directly · 24 of its ownK131722 I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · Recalled
- Descendant · 2 generations on · 19 of its ownK162674 BioPro Foot Plating SystemsBiopro, Inc. · 2017
- Descendant · cites it directly · 15 of its ownK131061 Restore Bunion Correction SystemNextremity Solutions · 2013
Showing 5 of 68 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 68 · See all- K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · cites it directly58descendants
- K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited · 2014 · 2 generations on28descendants
- K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · cites it directly24descendants
- K162674BioPro Foot Plating SystemsBiopro, Inc. · 2017 · 2 generations on19descendants
- K131061Restore Bunion Correction SystemNextremity Solutions · 2013 · cites it directly15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K915818 | Synthes (R) Titanium Small Reconstruction Plate | Synthes (Usa) | 1992 | 2 |
| −4 | K990094 | Kmi Wrist Fusion System | Kinetikos Medical, Inc. | 1999 | — |
| −3 | K991873 | Kmi Wrist Fusion System | Kinetikos Medical, Inc. | 1999 | — |
| −2 | K021321 | Wrist Fusion Plate | Acu Med, Inc. | 2002 | — |
| −1 | K050681 | Omnitech System & Easy Lock Osteosystem with Xtremities Plates | TriMed, Inc. | 2005 | — |
| 0 (this device) | K092670 | Biodrive Micro Screw System | Ebi,Llc D/B/A Biomet Trauma | 2009 | — |
| +1 | K111678 | Ortho Solutions Extremity Fixation Implants for Osteosysnthesis | Ortho Solutions Limited | 2012 | 1 |
| +2 | K141784 | Ortho Solutions Ultos Plating System | Ortho Solutions Limited | 2014 | 2 |
| +1 | K131722 | I.T.S. Extremity Fixation Systems | I.T.S. GmbH | 2013 | 2 |
| +2 | K162674 | BioPro Foot Plating Systems | Biopro, Inc. | 2017 | — |
| +1 | K131061 | Restore Bunion Correction System | Nextremity Solutions | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 7 | 0 |
| 2016 | 3 | 0 |
| 2017 | 9 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 10 | 0 |
| 2024 | 8 | 0 |
| 2025 | 5 | 0 |
| 2026 | 8 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 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? (3)
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 |
|---|---|---|---|
| * | K050681 | Omnitech System & Easy Lock Osteosystem with Xtremities PlatesSummary page 2…, and principles of operation and do not present any new issues of safety or effectiveness: Examples of predicates include the Omnitech System distributed by TriMed Inc (K050681), the Self Countersinking Bone Screw distributed by Biomet (K013534) and the DynaFix Compression Bone Screw distributed by Biomet… | 2005 |
| * | K013534 | Self-Countersinking Bone ScrewSummary page 2…afety or effectiveness: Examples of predicates include the Omnitech System distributed by TriMed Inc (K050681), the Self Countersinking Bone Screw distributed by Biomet (K013534) and the DynaFix Compression Bone Screw distributed by Biomet Trauma (K030706). DEPARTMENT OF HEALTH & HUMAN S… | 2001 |
| * | K030706 | Ebi Dynafix Compression Bone ScrewSummary page 2…tributed by TriMed Inc (K050681), the Self Countersinking Bone Screw distributed by Biomet (K013534) and the DynaFix Compression Bone Screw distributed by Biomet Trauma (K030706). DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service… | 2003 |
What descends from it? (68)
See all 685 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 17 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- 6 of the 28 ancestors have a recall of any class.
- Of its descendants, K111678 (Ortho Solutions Limited, 2012) has gone furthest, with 58 descendants of its own.
- 7 other devices also cite its predicate K050681.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The Biomet BioDrive Screw System is indicated for alignment and stabilization of small bone fractures.
Specifically:
* Fixation of small bones, such as those in the foot, ankle, wrist, elbow and hand for treatment of fractures, non-unions, or mal-unions
* Ligament reconstruction
* Osteochondritis dissecans
* Arthrodesis of the foot, ankle, wrist, elbow and hand
* Small bone osteotomies, including first metatarsal head osteotomy, metatarsal osteotomies, phalangeal osteotomies, and carpal/metacarpal osteotomies
These procedures may be indicated as a result of trauma, deformity, osteoarthritis, and rheumatoid arthritis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092670 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092670: Biodrive Micro Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092670
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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