# K131082: Interform Interbody Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Next Orthosurgical
- Decided: Aug 26, 2013 after 130 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: 10 generations back to K841189 (1984). 54 ancestors in all.
595 later devices descend from it; 3 cite it directly.
1 of 650 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071724: Lucent, Spinal Elements, Inc. (2007) Summary page 1.
- K081968: Modification to Lucent, Spinal Elements, Inc. (2008)
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 1.
- K082310: Hollywood, Pacifica, Redondo, Ventura, Seaspine, Inc. (2008) Summary page 1.
- K100042: Difusion Technologies Xiphos Interbody Fusion System, Difusion Technologies (2010) Summary page 1.
- K100089: Synthes T-Pal Spacer, Synthes Spine (2010) Summary page 1.
- K071795: Nuvasive Coroent System, Nuvasive, Inc. (2007) Summary page 1.
- K081611: Nuvasive Coroent System, Nuvasive, Inc. (2008) Summary page 1.
- K073291: Capstone Spinal System, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 1.
- K072791: Oracle Spacer, Opal Spacer, Synthes Spine (2007) Summary page 1.
- K100516: Anyplus Peek Cages, GS Medical Co., Ltd. (2010) Summary page 1.
- K023570: Modification to Verte-Stack Spinal System, Medtronic Sofamor Danek (2002) Summary page 1.
- K062933: Synthes Oracle Spacer, Synthes Spine Co.Lp (2007) Summary page 1.
- K092193: Spinal Usa Interbody Cages, Spinal USA (2009) Summary page 1.
- K091278: Valeo Spacer System, Amedica Corp. (2010) Summary page 1.

## Most influential descendants
- K141665: NuVasive CoRoent System (2015), 588 descendants of its own
- K151472: NuVasive CoRoent Lumbar System (2015), 479 descendants of its own
- K150994: NuVasive CoRoent Thoracolumbar Implants (2015), 402 descendants of its own
- K153419: NuVasive CoRoent Thoracolumbar System (2016), 400 descendants of its own
- K160051: NuVasive® Interfixated Interbody System (2016), 396 descendants of its own

## Indications for use
When used as an intervertebral body fusion device, the lnterFornm Lumbar Interbody Cage System is intended for spinal fusion procedures at one or two contiguous levels ([2-Si) in skeletally mature patients with degenerative disc disease (DOD). DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DOD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft to facilitate fusion. Additionally, the InterForm Lumbar Interbody Cage System is intended for use with supplemental spinal fixation systems cleared for use in the lumbar spine. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

Source page: https://510kreport.com/device/K131082
Methodology: https://510kreport.com/methodology