510(k) · Cleared
ClearedMarrowminer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stemcor Systems, Inc. · GDM Needle, Aspiration And Injection, Reusable
Cleared on Sep 24, 2007 as substantially equivalent to K964073 (Biomedical Ent., Inc., 1996) and 2 other predicates after a 90-day review. Its family tree reaches back 4 generations to 1989. 1 of the 18 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Sep 24, 2007
- Review
- 90 days
- Class
- Class I
- Product code
- GDM
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K890925 (1989). 13 ancestors in all. 4 later devices descend from it, 1 citing it directly. 1 of the 18 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK890925 Manan Bone Marrow Biopsy NeedleManan Medical Products, Inc. · 1989 · Recalled
- 3 generations backK961959 MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1996
- 2 generations backK980196 MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1998 · Recalled (Class I)
- 1 generation backK043523 Interv Brand Snarelok Bone Marrow Biopsy NeedleMedical Device Technologies, Inc. · 2005
- This deviceK071732 MarrowminerStemcor Systems, Inc. · 2007
- Descendant · cites it directly · 3 of its ownK152474 Avitus Bone HarvesterAvitus Orthopaedics, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 2 of its ownK170539 Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone…Avitus Orthopaedics, Inc. · 2017 · Recalled
- Descendant · 3 generations on · 1 of its ownK210631 Avitus (r) Bone HarvesterAvitus Orthopaedics, Inc. · 2021
- Descendant · 4 generations on · 0 of its ownK243407 Forcyte Autograft Harvest KitForcyte Medical, LLC · 2025
Class I recalls in this family
- K980196 MD Tech Biopsy Set for Bone and Bone Marrow2 generations back · 1998
Most influential descendants
Showing 4 of 4 · See all- K152474Avitus Bone HarvesterAvitus Orthopaedics, Inc. · 2015 · cites it directly3descendants
- K170539Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone…Avitus Orthopaedics, Inc. · 2017 · 2 generations on2descendants
- K210631Avitus (r) Bone HarvesterAvitus Orthopaedics, Inc. · 2021 · 3 generations on1descendant
- K243407Forcyte Autograft Harvest KitForcyte Medical, LLC · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K890925 | Manan Bone Marrow Biopsy Needle | Manan Medical Products, Inc. | 1989 | 7 |
| −3 | K961959 | MD Tech Biopsy Set for Bone and Bone Marrow | Medical Device Technologies, Inc. | 1996 | — |
| −2 | K980196 | MD Tech Biopsy Set for Bone and Bone Marrow | Medical Device Technologies, Inc. | 1998 | Class I |
| −1 | K043523 | Interv Brand Snarelok Bone Marrow Biopsy Needle | Medical Device Technologies, Inc. | 2005 | — |
| 0 (this device) | K071732 | Marrowminer | Stemcor Systems, Inc. | 2007 | — |
| +1 | K152474 | Avitus Bone Harvester | Avitus Orthopaedics, Inc. | 2015 | 1 |
| +2 | K170539 | Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm… | Avitus Orthopaedics, Inc. | 2017 | 1 |
| +3 | K210631 | Avitus (r) Bone Harvester | Avitus Orthopaedics, Inc. | 2021 | — |
| +4 | K243407 | Forcyte Autograft Harvest Kit | Forcyte Medical, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 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.
1 device in this family has a Class I recall. 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K961902 | FDA’s K961902 is Siemens Beam Shaper Our reading of the summary gave K961902, FDA’s number for Siemens Beam Shaper (Siemens Medical Solutions USA, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Biomedical Eng, Inc. BoneHog/Excaliber”. Kept off the family tree. Summary page 1…Phone: (714) 695-9269 Fax: (714) 779-1239 Predicate Device(s): Biomedical Eng, Inc. BoneHog/Excaliber, K961902, K964073, K971783. Medical Device Technologies, Inc. InterV SnareLok Bone… | 1996 |
| * | K964073 | Bme Bone Drill BitsSummary page 1…) 695-9269 Fax: (714) 779-1239 Predicate Device(s): Biomedical Eng, Inc. BoneHog/Excaliber, K961902, K964073, K971783. Medical Device Technologies, Inc. InterV SnareLok Bone Marrow Biops… | 1996 |
| Kept off the family tree | K971783 | FDA’s K971783 is Synthes Elastic Intramedullary Nail (Ein) System Our reading of the summary gave K971783, FDA’s number for Synthes Elastic Intramedullary Nail (Ein) System (Synthes (Usa)). Its FDA name has none of the distinctive words the summary uses for the device it names, “Biomedical Eng, Inc. BoneHog/Excaliber”. Kept off the family tree. Summary page 1…9 Fax: (714) 779-1239 Predicate Device(s): Biomedical Eng, Inc. BoneHog/Excaliber, K961902, K964073, K971783. Medical Device Technologies, Inc. InterV SnareLok Bone Marrow Biopsy Needle,… | 1997 |
| * | K043523 | Interv Brand Snarelok Bone Marrow Biopsy NeedleSummary page 1…K964073, K971783. Medical Device Technologies, Inc. InterV SnareLok Bone Marrow Biopsy Needle, K043523. Vidacare Bone Marrow Aspiration Set, K062833 Device Description: The MarrowMiner is a device int… | 2005 |
| * | K062833 | Powered EZ-IO Bone Marrow Aspiration SystemSummary page 1…al Device Technologies, Inc. InterV SnareLok Bone Marrow Biopsy Needle, K043523. Vidacare Bone Marrow Aspiration Set, K062833 Device Description: The MarrowMiner is a device intended for harvesting bone marrow. The Ste… | 2006 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152474 | Avitus Bone Harvester | 2015 | 3 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K980196MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1998 · 2 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
- 2 of the 13 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K152474 (Avitus Orthopaedics, Inc., 2015) has gone furthest, with 3 descendants of its own.
How does its category compare?
All GDM devicesGDM Needle, Aspiration And Injection, Reusable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · GDM
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · GDM
Too few GDM 510(k)s in any year since 2007 to give a median.
Recalls per year · GDM
2in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GDM
5in 2025
MAUDE reports naming product code GDM, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 2 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 8 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MarrowMiner is intended for harvesting bone marrow.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071732 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071732: Marrowminer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071732
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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