510(k) · Cleared
ClearedBme Bone Drill Bits
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomedical Ent., Inc. · GEY Motor, Surgical Instrument, Ac-Powered
Cleared on Nov 14, 1996 after a 34-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Nov 14, 1996
- Review
- 34 days
- Class
- Class I
- Product code
- GEY
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK964073 Bme Bone Drill BitsBiomedical Ent., Inc. · 1996
- Descendant · cites it directly · 4 of its ownK071732 MarrowminerStemcor Systems, Inc. · 2007
- Descendant · 2 generations on · 3 of its ownK152474 Avitus Bone HarvesterAvitus Orthopaedics, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 2 of its ownK170539 Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone…Avitus Orthopaedics, Inc. · 2017 · Recalled
- Descendant · 4 generations on · 1 of its ownK210631 Avitus (r) Bone HarvesterAvitus Orthopaedics, Inc. · 2021
- Descendant · 5 generations on · 0 of its ownK243407 Forcyte Autograft Harvest KitForcyte Medical, LLC · 2025
Most influential descendants
Showing 5 of 5 · See all- K071732MarrowminerStemcor Systems, Inc. · 2007 · cites it directly4descendants
- K152474Avitus Bone HarvesterAvitus Orthopaedics, Inc. · 2015 · 2 generations on3descendants
- K170539Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone…Avitus Orthopaedics, Inc. · 2017 · 3 generations on2descendants
- K210631Avitus (r) Bone HarvesterAvitus Orthopaedics, Inc. · 2021 · 4 generations on1descendant
- K243407Forcyte Autograft Harvest KitForcyte Medical, LLC · 2025 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964073 | Bme Bone Drill Bits | Biomedical Ent., Inc. | 1996 | — |
| +1 | K071732 | Marrowminer | Stemcor Systems, Inc. | 2007 | — |
| +2 | K152474 | Avitus Bone Harvester | Avitus Orthopaedics, Inc. | 2015 | 1 |
| +3 | K170539 | Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm… | Avitus Orthopaedics, Inc. | 2017 | 1 |
| +4 | K210631 | Avitus (r) Bone Harvester | Avitus Orthopaedics, Inc. | 2021 | — |
| +5 | K243407 | Forcyte Autograft Harvest Kit | Forcyte Medical, LLC | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071732 | Marrowminer | 2007 | 4 |
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?
- Of its descendants, K071732 (Stemcor Systems, Inc., 2007) has gone furthest, with 4 descendants of its own.
How does its category compare?
All GEY devicesGEY Motor, Surgical Instrument, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEY
FDA has decided no GEY device since 2007.
Median 510(k) review, days · GEY
Too few GEY 510(k)s in any year since 2007 to give a median.
Recalls per year · GEY
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GEY
965in 2025
MAUDE reports naming product code GEY, 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 | 0 | — | 0 | 19 |
| 2008 | 0 | — | 1 | 9 |
| 2009 | 0 | — | 1 | 4 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 11 |
| 2012 | 0 | — | 1 | 14 |
| 2013 | 0 | — | 2 | 901 |
| 2014 | 0 | — | 0 | 738 |
| 2015 | 0 | — | 0 | 2,013 |
| 2016 | 0 | — | 0 | 1,943 |
| 2017 | 0 | — | 0 | 2,119 |
| 2018 | 0 | — | 0 | 1,288 |
| 2019 | 0 | — | 0 | 1,131 |
| 2020 | 0 | — | 0 | 952 |
| 2021 | 0 | — | 0 | 1,145 |
| 2022 | 0 | — | 0 | 1,360 |
| 2023 | 0 | — | 0 | 1,444 |
| 2024 | 0 | — | 0 | 1,447 |
| 2025 | 0 | — | 0 | 965 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K964073 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964073: Bme Bone Drill Bits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964073
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026