# K032534: Synthes Afs

- Pathway: 510(k) (Traditional)
- Applicant: Synthes Spine
- Decided: Apr 1, 2004 after 230 days
- Product code: NQW (Orthosis, Spine, Plate, Laminoplasty, Metal)
- 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: 2 generations back to K761228 (1976). 10 ancestors in all.
43 later devices descend from it; 18 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963741: Leibinger Luhr Small Craniomaxillofacial Bone Screws, Howmedica Leibinger, Inc. (1997) Summary page 1.
- K961485: Forefoot Reconstruction System, Howmedica Corp. (1996) Summary page 1.
- K961497: Profyle Titanium Hand and Small Fragment System, Howmedica, Inc. (1996) Summary page 1.
- K850631: Kirschner Orthopedic Wire, Eyelet Cerclage Wires, Kirschner Medical Corp. (1985) Summary page 1.

## Most influential descendants
- K091994: Mountaineer Laminoplasty System (2010), 17 descendants of its own
- K043338: Blakstone Laminoplasty Fixation System (2005), 17 descendants of its own
- K080664: Relieve Laminoplasty Fixation System (2008), 11 descendants of its own
- K121732: Canopy Laminoplasty Fixation System (2012), 10 descendants of its own
- K113802: Escalate Laminoplasty System (2012), 7 descendants of its own

## Indications for use
The Synthes ArchTM Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Arch TM Fixation System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.

Source page: https://510kreport.com/device/K032534
Methodology: https://510kreport.com/methodology