# K072253: Synfix-LR Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Synthes Spine Co.Lp
- Decided: Oct 12, 2007 after 59 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- 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: 2 generations back to K010530 (2001). 4 ancestors in all.
1,250 later devices descend from it; 28 cite it directly.
1 of 1,255 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062083: Synfix -LR, Synthes Spine Co.Lp (2007) Summary page 1.
- P950002: Bak Interbody Fusion System, Zimmer Spine, Inc. (1996) Summary page 1.

## Most influential descendants
- K073470: Avs PL Peek Spacers, Models 48351XXX and 48353XXX (2008), 1,102 descendants of its own
- K080758: Avs PL Peek Spacers, Models 48351 and 48353 (2008), 1,091 descendants of its own
- K080083: Intrepid Spinal System (2008), 932 descendants of its own
- K073109: Stalif TT Intervertebral Body Fusion System (2008), 907 descendants of its own
- K081395: Solitaire Peek-Optima Anterior Spinal System (2008), 854 descendants of its own

## Recalls of this device
- Nov 20, 2008 · Not classified · Z-0931-2009: screwdriver tip may break off and lodge in the screw head

## Indications for use
The SynFix-LR device is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the SynFix~LR can be packed with autograft. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

Source page: https://510kreport.com/device/K072253
Methodology: https://510kreport.com/methodology