# K121548: Spinevu Endoscopic Spine System (Sess)

- Pathway: 510(k) (Special)
- Applicant: Spine View, Inc.
- Decided: Aug 16, 2012 after 83 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: 8 generations back to K991794 (1999). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113362: Spinevu Endoscopic Spine System (Sess), Spine View, Inc. (2012) Summary page 1.
- K994363: Instruments for Minimally Invasive Spinal Surgery (Miss), Richard Wolf Medical Instruments Corp. (2000) Summary page 1.
- (no number) Joimax EndoReamer and EndoChisel Assembly: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K081511: 2.0 PK Suture Anchor T, 2.0 PK Suture Anchor S, Smith & Nephew, Inc. (2008). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Spine View Minimally Invasive Surgical (MIS) Decompression System is indicated for use to facilitate access and visualization in the surgical area of the cervical, thoracic, or lumbar spine and is accessorized with surgical tools for interventional spinal procedures such as discectomy, nucleotomy and foraminotomy.

Source page: https://510kreport.com/device/K121548
Methodology: https://510kreport.com/methodology