# K964007: Acromed Cable/Wire Pedicle Screw

- Pathway: 510(k) (Traditional)
- Applicant: Acromed Corp.
- Decided: Dec 16, 1996 after 70 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- 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 K951657 (1995). 1 ancestor in all.
46 later devices descend from it; 2 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951657: VSP (Variable Screw Placement) Spinal Fixation System, Pedicle Screw (S), Spine Plate (S), Washer (S) & Nut (S), Acromed Corp. (1995) Summary page 2.
- (no number) Harrington Lag Screw: named in the summary without a submission number

## Most influential descendants
- K081252: Expedium 4.5MM Spine System (2008), 44 descendants of its own
- K150417: Astra Spine System (2015), 21 descendants of its own
- K211323: ASTRA Spine System (2021), 12 descendants of its own
- K100757: Tilock Pedicle Screw System (2010), 9 descendants of its own
- K223273: ASTRA Spine System (2022), 8 descendants of its own

## Indications for use
The AcroMed Cable/Wire Pedicle Screw is designed to be utilized with the ISOLA Spine System (K951657). When used with pedicle screws, the ISOLA implants are intended for use in grade 3 or 4 spondylolisthesis at L5-S1 utilizing autologous bone graft and intended to be removed after solid fusion is attained. Levels of attachment for the indication range from L3 to the sacrum. The ISOLA Spinal System, when not used with pedicle screws, is intended for hook, wire, and/or sacral/iliac screw fixation from T1 to the iliunVsacrum, The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture and previous failed surgery. As a whole, the ISOLA Spinal System is imended for T1-sacral fixation. Screw fixation is from L3-S1.

Source page: https://510kreport.com/device/K964007
Methodology: https://510kreport.com/methodology