# K965102: Acromed Pedicle Screw

- Pathway: 510(k) (Traditional)
- Applicant: Acromed Corp.
- Decided: May 8, 1997 after 139 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- 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.
1 later device descends 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)
- K951116: Acromed Pedicle Screw, Acromed Corp. (1995) Summary page 2.

## Most influential descendants
- K191212: CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System (2019), 0 descendants of its own

## Recalls of this device
- Oct 11, 2013 · Class II · Z-1011-2014: Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packag

## Indications for use
The AcroMed 4.75 mm Pedicle Screw is designed to be utilized with the VSP Spinal Fixation System. The VSP Spinal Fixation System is intended for use in grade 3 or 4 spondylolisthesis at L5-S1, utilizing autologous bone graft, having the device fixed or attached to the lumbar or sacral spine and intended to be removed after solid fusion is attained. Levels of attachment for this indication range from L3 to the sacrum.

Source page: https://510kreport.com/device/K965102
Methodology: https://510kreport.com/methodology