510(k) · Cleared
ClearedEbi Dynafix Compression Bone Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ebi, L.P. · HWC Screw, Fixation, Bone
Cleared on Mar 20, 2003 as substantially equivalent to K792022 (Zimmer, Inc., 1979) and 2 other predicates after a 14-day review. Its family tree reaches back 2 generations to 1979. 69 later devices descend from it.
- Decided
- Mar 20, 2003
- Review
- 14 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K792022 (1979). 4 ancestors in all. 69 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 1 generation backK020791 HBS Headless Bone ScrewMillennium Medical Technologies, Inc. · 2002
- This deviceK030706 Ebi Dynafix Compression Bone ScrewEbi, L.P. · 2003
- Descendant · cites it directly · 68 of its ownK092670 Biodrive Micro Screw SystemEbi,Llc D/B/A Biomet Trauma · 2009
- Descendant · 2 generations on · 58 of its ownK111678 Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · Recalled
- Descendant · 3 generations on · 28 of its ownK141784 Ortho Solutions Ultos Plating SystemOrtho Solutions Limited · 2014 · Recalled
- Descendant · 2 generations on · 24 of its ownK131722 I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · Recalled
- Descendant · 3 generations on · 19 of its ownK162674 BioPro Foot Plating SystemsBiopro, Inc. · 2017
Showing 5 of 69 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 69 · See all- K092670Biodrive Micro Screw SystemEbi,Llc D/B/A Biomet Trauma · 2009 · cites it directly68descendants
- K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited · 2012 · 2 generations on58descendants
- K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited · 2014 · 3 generations on28descendants
- K131722I.T.S. Extremity Fixation SystemsI.T.S. GmbH · 2013 · 2 generations on24descendants
- K162674BioPro Foot Plating SystemsBiopro, Inc. · 2017 · 3 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −1 | K020791 | HBS Headless Bone Screw | Millennium Medical Technologies, Inc. | 2002 | — |
| 0 (this device) | K030706 | Ebi Dynafix Compression Bone Screw | Ebi, L.P. | 2003 | — |
| +1 | K092670 | Biodrive Micro Screw System | Ebi,Llc D/B/A Biomet Trauma | 2009 | — |
| +2 | K111678 | Ortho Solutions Extremity Fixation Implants for Osteosysnthesis | Ortho Solutions Limited | 2012 | 1 |
| +3 | K141784 | Ortho Solutions Ultos Plating System | Ortho Solutions Limited | 2014 | 2 |
| +2 | K131722 | I.T.S. Extremity Fixation Systems | I.T.S. GmbH | 2013 | 2 |
| +3 | K162674 | BioPro Foot Plating Systems | Biopro, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 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 |
|---|---|---|---|
| * | K792022 | Herbert Bone ScrewSummary page 1…Fixation Fastener, 21 CFR 888.3040 3. Predicate or legally marketed devices that are substantially equivalent: Zimmer Herbert Screw (K792022) 0 Acumed Acutrak (K930834) 0 Millennium HBS Headless Bone Screw (K020791) 4. Description of the de… | 1979 |
| * | K930834 | AcutractSummary page 1…CFR 888.3040 3. Predicate or legally marketed devices that are substantially equivalent: Zimmer Herbert Screw (K792022) 0 Acumed Acutrak (K930834) 0 Millennium HBS Headless Bone Screw (K020791) 4. Description of the device: The EBI@DynaFix@Compression Bone Sc… | 1993 |
| * | K020791 | HBS Headless Bone ScrewSummary page 1…are substantially equivalent: Zimmer Herbert Screw (K792022) 0 Acumed Acutrak (K930834) 0 Millennium HBS Headless Bone Screw (K020791) 4. Description of the device: The EBI@DynaFix@Compression Bone Screw is intended to be inserted across the fracture site.… | 2002 |
What descends from it? (69)
See all 691 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092670 | Biodrive Micro Screw System | 2009 | 68 |
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 24 years and passes through 3 companies; a new generation was cleared every 22.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K092670 (Ebi,Llc D/B/A Biomet Trauma, 2009) has gone furthest, with 68 descendants of its own.
- 17 other devices also cite its predicate K792022.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The EBI@DynaFix@Compression Bone Screws are indicated for fusions, fractures, or osteotomies of the Upper and Lower Extremities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030706 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030706: Ebi Dynafix Compression Bone Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030706
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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