# K080083: Intrepid Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek
- Decided: Apr 10, 2008 after 90 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K841189 (1984). 30 ancestors in all.
932 later devices descend from it; 3 cite it directly.
1 of 963 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072253: Synfix-LR Spacer, Synthes Spine Co.Lp (2007) Summary page 2.
- P970015: Inter Fix Threaded Fusion Device, Sofamor Danek (1999) Summary page 2.
- P950002: Bak Interbody Fusion System, Zimmer Spine, Inc. (1996) Summary page 2.
- P950019: Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation, Stryker Spine (1996) Summary page 2.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 2.
- K072120: Paramount Intervertebral Body Fusion Device, Innovative Spinal Technologies, Inc. (2007) Summary page 2.

## Most influential descendants
- K073109: Stalif TT Intervertebral Body Fusion System (2008), 907 descendants of its own
- K083475: Lucent Magnum (2009), 834 descendants of its own
- K081849: Blackstone Pillar SA Partial Vertebral Body Replacement Device (2008), 753 descendants of its own
- K100043: Coroent XLR Standalone System (2010), 744 descendants of its own
- K091813: Intrepid Spinal System (2009), 719 descendants of its own

## Recalls of this device
- Feb 6, 2009 · Not classified · Z-1797-2009: The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment.
- Feb 6, 2009 · Not classified · Z-1798-2009: The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment.
- Feb 6, 2009 · Not classified · Z-1803-2009: The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment.
- Feb 6, 2009 · Not classified · Z-1800-2009: The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment.
- Feb 6, 2009 · Not classified · Z-1799-2009: The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment.
- Feb 6, 2009 · Not classified · Z-1796-2009: The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment.
- Feb 6, 2009 · Not classified · Z-1802-2009: The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment.
- Feb 6, 2009 · Not classified · Z-1801-2009: The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment.

## Indications for use
The INTREPIDTM Spinal System is indicated for use with autogenous bone graft 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 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain 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. These implants may be implanted via a laparoscopic or an open anterior approach. The INTREPIDTM interbody device is intended to be used with the three titanium alloy screws which accompany the implant. If the physician chooses to use less than three, or none of the provided screws, then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability.

Source page: https://510kreport.com/device/K080083
Methodology: https://510kreport.com/methodology