# K972768: Blackstone Medical, Inc. Laparoscopic Disc Removal System

- Pathway: 510(k) (Traditional)
- Applicant: Blackstone Medical, Inc.
- Decided: Sep 25, 1997 after 63 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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) Surgical Dynamics, Inc. Working Channel Scope and Instrument Set: named in the summary without a submission number
- (no number) Blackstone Medical Inc. Nucleus Pulposus Evacuator System: named in the summary without a submission number

## Most influential descendants
- K122861: XTOOL (2012), 1 descendant of its own
- K213978: TELIGEN System (2022), 0 descendants of its own

## Indications for use
The BLACKSTONE MEDICAL INC. Laparoscopic Disc Removal System is to be used in the anterior Laparoscopic decompression of the intervertebral disc in the lumbar region of the spine. Unilateral leg pain greater than back pain. Paresthetic discomfort in a specific dermatomal distribution. Positive straight leg raising test and/or positive bowstring sign. Patient demonstrates possible neurological findings (wasting, weakness, sensory alteration, and reflex alteration). Patient shows no improvement after at least six weeks of conservative therapy. A positive CT or MRI that shows a subligamentous herniation at the location consistent with clinical findings.

Source page: https://510kreport.com/device/K972768
Methodology: https://510kreport.com/methodology