# K213860: ArthroFree Wireless Surgical Camera System

- Pathway: 510(k) (Traditional)
- Applicant: Lazurite Holdings, LLC
- Decided: Mar 23, 2022 after 103 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K950862 (1995). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142603: Stryker Precision HD Camera System, Stryker Endoscopy (2014) Summary page 5.

## Most influential descendants
- K242606: Nuvis® Wireless HD Camera System (Nuvis-2K) (2025), 0 descendants of its own

## Indications for use
The ArthroFree System is indicated for use in arthroscopy, general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery or wherever a laparoscope /endoscope/ arthroscope is indicated for use. The users of the camera are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, neurosurgeons and urologists. The ArthroFree System is indicated for use in diagnostic and operative endoscopic procedures, supplying illumination and visualization of an interior cavity of the body. Examples of common general endoscopic surgeries are listed below. • laparoscopic cholecystectomy • laparoscopic hernia repair • laparoscopic appendectomy • laparoscopic pelvic lymph node dissection • laparoscopically assisted hysterectomy • laparoscopic and thorascopic anterior spinal fusion • anterior cruciate ligament reconstruction • knee arthroscopy • shoulder arthroscopy • small joint arthroscopy • decompression fixation • wedge resection • lung biopsy • pleural biopsy • dorsal sympathectomy • pleurodesis • internal mammary artery dissection for coronary artery bypass • coronary artery bypass grafting where endoscopic visualization is indicated • examination of the evacuated cardiac chamber during performance of valve replacement

Source page: https://510kreport.com/device/K213860
Methodology: https://510kreport.com/methodology