510(k) · Cleared
Recalled · Class II · 2019Avitus Bone Harvester
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avitus Orthopaedics, Inc. · KNW Instrument, Biopsy
Cleared on Oct 23, 2015 as substantially equivalent to K071732 (Stemcor Systems, Inc., 2007) after a 53-day review. Its family tree reaches back 5 generations to 1989. 1 of the 18 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it. It has been recalled once.
- Decided
- Oct 23, 2015
- Review
- 53 days
- Class
- Class II
- Product code
- KNW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K890925 (1989). 14 ancestors in all. 3 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 · 5 generations backK890925 Manan Bone Marrow Biopsy NeedleManan Medical Products, Inc. · 1989 · Recalled
- 4 generations backK961959 MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1996
- 3 generations backK980196 MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1998 · Recalled (Class I)
- 2 generations backK043523 Interv Brand Snarelok Bone Marrow Biopsy NeedleMedical Device Technologies, Inc. · 2005
- 1 generation backK071732 MarrowminerStemcor Systems, Inc. · 2007
- This deviceK152474 Avitus Bone HarvesterAvitus Orthopaedics, Inc. · 2015
- Descendant · cites it directly · 2 of its ownK170539 Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone…Avitus Orthopaedics, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK210631 Avitus (r) Bone HarvesterAvitus Orthopaedics, Inc. · 2021
- Descendant · 3 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 Marrow3 generations back · 1998
Most influential descendants
Showing 3 of 3 · See all- K170539Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone…Avitus Orthopaedics, Inc. · 2017 · cites it directly2descendants
- K210631Avitus (r) Bone HarvesterAvitus Orthopaedics, Inc. · 2021 · 2 generations on1descendant
- K243407Forcyte Autograft Harvest KitForcyte Medical, LLC · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K890925 | Manan Bone Marrow Biopsy Needle | Manan Medical Products, Inc. | 1989 | 7 |
| −4 | K961959 | MD Tech Biopsy Set for Bone and Bone Marrow | Medical Device Technologies, Inc. | 1996 | — |
| −3 | K980196 | MD Tech Biopsy Set for Bone and Bone Marrow | Medical Device Technologies, Inc. | 1998 | Class I |
| −2 | K043523 | Interv Brand Snarelok Bone Marrow Biopsy Needle | Medical Device Technologies, Inc. | 2005 | — |
| −1 | K071732 | Marrowminer | Stemcor Systems, Inc. | 2007 | — |
| 0 (this device) | K152474 | Avitus Bone Harvester | Avitus Orthopaedics, Inc. | 2015 | — |
| +1 | K170539 | Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm… | Avitus Orthopaedics, Inc. | 2017 | 1 |
| +2 | K210631 | Avitus (r) Bone Harvester | Avitus Orthopaedics, Inc. | 2021 | — |
| +3 | 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 |
|---|---|---|
| 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.
Top candidate predicates for a new KNW device
- #1 K260572 Marrow Marxmanscore 14.5 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K071732 | MarrowminerSummary page 5…5.7 Legally Marketed Device To Which The Device Is Substantially Equivalent The AvitusTM Bone Harvester is substantially equivalent to the MarrowMiner cleared under K071732. 5.8 Description Of The Device The proposed device is a manual surgical instrument that cuts cancellous bone by manual actua… | 2007 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170539 | Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone… | 2017 | 2 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 18, 2019 | Class II | Z-1046-2019 | Packaging process control | Breach in the sterile barrier pouch may compromise sterility of the 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 · 3 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 7.0 years on median.
- 2 of the 14 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K170539 (Avitus Orthopaedics, Inc., 2017) has gone furthest, with 2 descendants of its own.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · KNW
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNW
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNW
1in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · KNW
1,667in 2025
MAUDE reports naming product code KNW, 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 | 6 | 94 | 1 | 766 |
| 2008 | 4 | 53 | 7 | 363 |
| 2009 | 6 | 35 | 3 | 351 |
| 2010 | 3 | 57 | 2 | 162 |
| 2011 | 10 | 64 | 5 | 67 |
| 2012 | 7 | 94 | 1 | 93 |
| 2013 | 3 | 100 | 1 (1) | 98 |
| 2014 | 8 | 95 | 3 | 193 |
| 2015 | 10 | 106 | 0 | 591 |
| 2016 | 9 | 127 | 5 | 297 |
| 2017 | 8 | 90 | 1 | 760 |
| 2018 | 7 | 71 | 0 | 1,012 |
| 2019 | 5 | 94 | 4 | 4,195 |
| 2020 | 8 | 92 | 0 | 5,120 |
| 2021 | 9 | 54 | 3 | 1,020 |
| 2022 | 8 | 203 | 3 | 535 |
| 2023 | 7 | 164 | 2 | 931 |
| 2024 | 5 | 114 | 1 | 1,283 |
| 2025 | 12 | 178 | 0 | 1,667 |
| 2026 | 7 | 29 | 4 (3) | — |
What is it indicated for?
The AvitusTM Bone Harvester is intended to harvest cancellous bone and bone marrow.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152474 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152474: Avitus Bone Harvester.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152474
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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