# K130506: Imse P-Tlif

- Pathway: 510(k) (Traditional)
- Applicant: Institute of Musculoskeletal Science & Education
- Decided: May 13, 2013 after 75 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K841189 (1984). 52 ancestors in all.
No later device cites it as a predicate yet.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121254: Camber Spine Technologies TLS 5.0 Inerbody Cage, Camber Spine Technologies (2013)
- K073440: Foundation Cage, Corelink, LLC (2008) Summary page 2.
- K093704: Avs PL Peek Spacers, Stryker Corp. (2009) Summary page 2.
- K113138: Aleutian System, K2m, Inc. (2012) Summary page 2.

## Indications for use
The Institute of Musculoskeletal Science & Education P-TUIF is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (ODD) of the lumbar spine at one or two contiguous levels from 12-Si. DOD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These ODD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Institute of Musculoskeletal Science & Education P-TLIF is to be used with autologous bone graft and implanted via an open transforaminal or posterior approach. Institute of Musculoskeletal Science & Education P-TLIF implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K130506
Methodology: https://510kreport.com/methodology