# K002824: Macs Modular Anterior Construct System

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap, Inc.
- Decided: May 8, 2001 after 239 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: 2 generations back to K983583 (1998). 3 ancestors in all.
254 later devices descend from it; 3 cite it directly.
0 of 258 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983622: Bodyform Thoraco-Lumbar Fixation System, Theken Surgical,Llc (1998) Summary page 2.
- K994347: Centaur Spinal System, Howmedica Osteonics Corp. (2000) Summary page 2.

## Most influential descendants
- K032059: Modification to Macs Modular Anterior Construct System (2003), 250 descendants of its own
- K070387: Expedium Spine System (2007), 248 descendants of its own
- K102249: Expedium Spine System (2010), 218 descendants of its own
- K111571: Viper Systems (2011), 203 descendants of its own
- K121020: Viper System (2012), 94 descendants of its own

## Indications for use
This anterolateral/anterior system consists of several vertebral screws, locking nuts, spine plates and rods. The points of attachment are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T1-L5). This system is intended to provide stabilization during the development of a solid spinal fusion. When used as an anterolateral/anterior spine plate and rod system, the macs™ modular anterior construct system is indicated for patients with: • Degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies Spondylolisthesis Spondylolysis Fracture Spinal stenosis Deformities (i.e., scoliosis, kyphosis, lordosis, whether neuromuscular or related to deficient posterior elements) Tumors (neoplastic disease) Pseudarthrosis Failed previous fusion surgery

Source page: https://510kreport.com/device/K002824
Methodology: https://510kreport.com/methodology