# K171324: Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Instrument Service and Savings, Inc.
- Decided: Jun 23, 2017 after 49 days
- Product code: NUJ (Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K011083 (2001). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083306: Modification to Arthrocare Arthrowands, Arthrocare Corp. (2008) Summary page 7.

## Indications for use
The Medline ReNewal Reprocessed ArthroCare ArthroWands models ASHA 4250-01; ASH 4250-01; ASHA 2530-01; ASHA 3730-01; ASHA 4830-01; and ASH 4830-01 and Medline ReNewal Reprocessed Smith & Nephew Dyonics model 72202140 ablation wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Ablation and Debridement: ACL/PCL (knee); acromioplasty (shoulder); articular cartilage (all joints); bursectomy (all joints); chondroplasty (all joints); fascia (all joints); ligament (all joints); notchplasty (knee); scar tissue (all joints); soft tissue (all joints);subacromial decompression (shoulder); synovectomy (all joints); and tendon (all joints). Excision and Resection: acetabular labrum (hip); articular labrum (all joints); capsule (all joints); capsular release (knee); cartilage flaps (knee); cysts (all joints); discoid meniscus (knee); frozen shoulder release (shoulder); glenoidale labrum (shoulder); lateral release (knee); ligament (all joints); loose bodies (all joints); meniscal cystectomy (knee); meniscectomy (knee); plica removal (all joints); scar tissue (all joints); soft tissue (all joints); synovial membrane (all joints); tendon (all joints); triangular fibrocartilage (TFCC), (wrist); and villusectomy (knee). Coagulation: ACL/PCL (knee); articular cartilage (all joints); carpal ligaments (wrist); glenohumeral capsule (shoulder); ligament (all joints); medial retinaculum (knee); rotator cuff (shoulder); tendon (all joints) and wrist tendons (wrist).

Source page: https://510kreport.com/device/K171324
Methodology: https://510kreport.com/methodology