# K960222: Percutaneous Endoscopic Discectomy

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Mar 8, 1996 after 52 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) 510(k) Arthroscopy instruments sold by Richard Wolf: named in the summary without a submission number
- (no number) Discectomy devices sold by AcuFlex: named in the summary without a submission number
- (no number) Discectomy devices sold by Smith + Nephew: named in the summary without a submission number
- (no number) Discectomy devices sold by Aesculap: named in the summary without a submission number

## Most influential descendants
- K994363: Instruments for Minimally Invasive Spinal Surgery (Miss) (2000), 2 descendants of its own
- 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 instruments are used for Percutaneous Lumbar Disc Decompression. This involves partial or complete removal of human intervertebral disc hernias or degenerative diseases within the lumbar region. The goal is to decompress spinal structures like roots of nerves. Performing procedures like the mentioned PDD (Percutaneous Disc Decompression) is restricted to trained surgeons. The procedure is normally supported by the use of navigational systems (e.g. CT's, MRI, or Neuronavigation).

Source page: https://510kreport.com/device/K960222
Methodology: https://510kreport.com/methodology