# K050795: Imbibe Bone Marrow Aspiration Needle

- Pathway: 510(k) (Traditional)
- Applicant: Orthovita, Inc.
- Decided: Jun 3, 2005 after 66 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K023088 (2002). 5 ancestors in all.
19 later devices descend from it; 5 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940025: Manan Bone Marrow Harvest Needles, Manan Medical Products, Inc. (1994) Summary page 1.
- K001132: Bone Biopsy Needle, Promex, Inc. (2000) Summary page 1.
- K041991: Aspirex - Bone Marrow Aspirate Kit, Isotis Orthobiologics, Inc. (2004) Summary page 1.

## Most influential descendants
- K131157: Ranfac Bone Marrow Aspiration Needle (2013), 12 descendants of its own
- K140991: Ranfac Aspiration Needle with Adjustable Guide (2014), 5 descendants of its own
- K150563: Marrow Cellution Bone Marrow Aspiration Needle (2015), 4 descendants of its own
- K240664: ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) (2024), 1 descendant of its own
- K223612: Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) (2023), 1 descendant of its own

## Indications for use
The Imbibe Bone Marrow Aspiration Needle is for use in aspirating Bone Marrow or Autologous blood by use of a syringe. The bone marrow or autologous blood may be combined with bone graft or bone void filler.

Source page: https://510kreport.com/device/K050795
Methodology: https://510kreport.com/methodology