# K994363: Instruments for Minimally Invasive Spinal Surgery (Miss)

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Mar 6, 2000 after 70 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K960222 (1996). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973405: Yeung Endoscopic Spine System, Richard Wolf Medical Instruments Corp. (1998) Summary page 1.
- K960222: Percutaneous Endoscopic Discectomy, Richard Wolf Medical Instruments Corp. (1996) Summary page 1.
- (no number) Endoscopic Spine Instruments: named in the summary without a submission number
- (no number) Miaspas Mini ALIF Instrument Set for Fusion: named in the summary without a submission number

## Most influential descendants
- K113362: Spinevu Endoscopic Spine System (Sess) (2012), 1 descendant of its own
- K121548: Spinevu Endoscopic Spine System (Sess) (2012), 0 descendants of its own

## Indications for use
The MISS instrument set is designed for transthoracic and transabdominal approaches to the spine. Hand instruments, such as osteotome, elevator, hook probe, spoon, curette, punch, compunction tube with obturator, and plug applicator are used for endoscopically controlled dissection, exploration, and manipulation of tissue through natural or surgically created passages. Rongeurs and punches are used under endoscopic control, to grasp, manipulate, and cut, as well as for the dissection and biopsy of tissue, organs, or foreign bodies. Suction irrigation punches are used for endoscopically controlled punching and removal of tissue through natural or surgically created passages. For examination, diagnosis, and / or therapy by personnel trained and qualified in connection with endoscopically used accessories in various medical disciplines, such as orthopedic and spinal surgery.

Source page: https://510kreport.com/device/K994363
Methodology: https://510kreport.com/methodology