# K183146: Ranfac Cartilage Biopsy Needle

- Pathway: 510(k) (Traditional)
- Applicant: Ranfac Corporation
- Decided: Apr 25, 2019 after 163 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: 7 generations back to K871390 (1987). 26 ancestors in all.
No later device cites it as a predicate yet.
1 of 27 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131157: Ranfac Bone Marrow Aspiration Needle, Ranfac, Corp. (2013) Summary page 4.

## Indications for use
The Cartilage Biopsy Needle is intended to obtain a sample of articular cartilage tissue during arthroscopy.

Source page: https://510kreport.com/device/K183146
Methodology: https://510kreport.com/methodology