# K173347: STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX

- Pathway: 510(k) (Traditional)
- Applicant: Centinel Spine, Inc.
- Decided: May 8, 2018 after 195 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: 17 generations back to K841189 (1984). 188 ancestors in all.
12 later devices descend from it; 5 cite it directly.
1 of 201 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150643: Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti, Centinel Spine, Inc. (2015) Summary page 11.
- K150053: STALIF C; STALIF C-Ti, Centinel Spine, Inc. (2015) Summary page 12.
- K130461: Stalif X, Centinel Spine, Inc. (2013) Summary page 12.
- K170503: EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages, Eit Emerging Implant Technologies GmbH (2017) Summary page 12.
- K122444: Cervical Cage, Eisertech, LLC (2012) Summary page 12.
- K140348: Interbody Cage, Eisertech, LLC (2015) Summary page 12.
- K163491: NuVasive CoRoent Small Interbody System, Nu Vasive, Incorporated (2017) Summary page 12.

## Most influential descendants
- K201453: Fortilink Cages with TiPlus Technology (2020), 4 descendants of its own
- K242260: aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM (2024), 3 descendants of its own
- K200458: Tailored-C Cervical Interbody Fusion System (2020), 3 descendants of its own
- K250827: aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams (2025), 2 descendants of its own
- K252894: aprevo® cervical interbody system (2026), 1 descendant of its own

## Indications for use
The STALIF C FLX™ device is intended to be used as an intervertebral body fusion cage as a standalone system used with bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space at one or two contiguous levels from the C2/C3 disc space to the C7/T1 disc space for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Patients with previous non-fusion spinal surgery at the treated level may be treated. The device system is designed for use with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion. The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage. The STALIF C FLX™ with lordotic angles greater than or equal to 10 degrees are required to be used with FDA-cleared supplemental fixation for use in the cervical spine. The STALIF M FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous 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 I 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. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach. The STALIF M FLX™ is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems. The STALIF M FLX™ with lordotic angles greater than or equal to 20 degrees are required to be used with FDA-cleared supplemental fixation for use in the lumbar spine. The STALIF L FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. These DDD patients may also have up to Grade I 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. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open lateral approach. The STALIF L FLX™ is required to be used with supplementary fixation systems (e.g., pedicle screws) that have been cleared for use in the lumbar spine. The STALIF Lateral-Oblique FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. These DDD patients may also have up to Grade I 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. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open lateral approach. The STALIF Lateral-Oblique FLX™ is required to be used with supplementary fixation systems (e.g., pedicle screws) that have been cleared for use in the lumbar spine. The ACTILIF C FLX™ is intended for spinal fusion procedures at multiple contiguous levels from the C2-C3 disc to the C7-T1 disc in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. The ACTILIF C FLX™ is to be used in a patient who has had six weeks of non-operative treatment prior to implantation of the cage. Implants are intended to be packed with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft). Patients with previous non-fusion spinal surgery at the treated level may be treated. The ACTILIF C FLX™ is intended to be used with a supplemental fixation system. The ACTILIF M FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous 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 I 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. Patients with previous non-fusion spinal surgery at the treated level may be treated. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion and are intended to be used with supplemental fixation instrumentation that has been cleared by the FDA for use in the lumbar spine. The ACTILIF L FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous 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 I 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. Patients with previous non-fusion spinal surgery at the treated level may be treated. These devices are intended for intervertebral body fusion and are intended to be used with supplemental fixation instrumentation that has been cleared by the FDA for use in the lumbar spine. The ACTILIF Lateral-Oblique FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous 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 I 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. Patients with previous non-fusion spinal surgery at the treated level may be treated. These devices are intended for intervertebral body fusion and are intended to be used with supplemental fixation instrumentation that has been cleared by the FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K173347
Methodology: https://510kreport.com/methodology