# K971248: Kaneda SR Anterior Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Acromed Corp.
- Decided: Jun 11, 1997 after 69 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- 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 K873826 (1988). 3 ancestors in all.
82 later devices descend from it; 7 cite it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K873826: Acromed/Kaneda Anterior Spinal Instrumentation, Acromed Corp. (1988) Summary page 2.
- K923703: Kaneda Anterior Spinal Multisegmental Fixation Dev, Acromed Corp. (1993) Summary page 2.
- K943819: Isola Anterior System, Acromed Corp. (1995) Summary page 2.

## Most influential descendants
- K100061: Cayman Screws Model K2-12-1000-XX, K2-12-1001-XX (2010), 73 descendants of its own
- K131533: Cayman MI Plate System (2013), 72 descendants of its own
- K172941: CASCADIA Interbody System (2018), 52 descendants of its own
- K181347: Aries® Lumbar Interbodies (2018), 24 descendants of its own
- K190016: Lateral Plate System (2019), 15 descendants of its own

## Indications for use
The Kaneda SR Anterior Spinal System is intended for anterolateral screw fixation to the T10-L3 levels of the spine, with all metal at least 1.cm. froma major vessel. Specific indications are degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, kyphosis, lordosis), tumor, fracture and revision of previous surgery. The Kaneda system is used in conjunction with the Isola Spine System. Specifically, the 1) Isola %4 Rods 2) Isola Open Caps and 3) the Isola Set Screws are interchangeable parts.

Source page: https://510kreport.com/device/K971248
Methodology: https://510kreport.com/methodology