# K963639: Acromed Pedicle Screw

- Pathway: 510(k) (Traditional)
- Applicant: Acromed Corp.
- Decided: Nov 14, 1996 after 63 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- 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 K951116 (1995). 1 ancestor in all.
414 later devices descend from it; 1 cites it directly.
0 of 416 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951116: Acromed Pedicle Screw, Acromed Corp. (1995) Summary page 2.

## Most influential descendants
- K982511: Depuy Motech Moss Miami Spinal Systems (1998), 413 descendants of its own
- K030383: Modification to Moss Miami Spinal System Polyaxial Screws (2003), 410 descendants of its own
- K071890: Zodiac 4.0 Polyaxial Spinal Fixation System (2007), 180 descendants of its own
- K093077: Zodiac Polyaxial Spinal Fixation System (2009), 170 descendants of its own
- K100685: Zodiac Polyaxial Spinal Fixation System (2010), 168 descendants of its own

## Indications for use
The AcroMed Pedicle Screw is designed to be utilized with the ISOLA Spine System (K944737). The ISOLA Spinal System, when used with pedicle screws, is 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. The ISOLA Spinal System, when not used with pedicle screws, is intended hook, wire, and/or sacral/iliac screw fixation from T1 to the ilium/sacrum. 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 intended for T1-sacral fixation. Screw fixation is from L3-81. The component that is the subject of this premarket notification, the 4.75 mm diameter pedicle screw, is a line extension version of AcroMed Pedicle Screws previously cleared under K951657 for the ISOLA system. It is intended for use in pediatric and other applications where anatomic considerations limit the size of the implants that can be used for internal fixation applications.

Source page: https://510kreport.com/device/K963639
Methodology: https://510kreport.com/methodology