# K201453: Fortilink Cages with TiPlus Technology

- Pathway: 510(k) (Traditional)
- Applicant: Paradigm Spine GmbH
- Decided: Oct 7, 2020 after 128 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: 23 generations back to K841189 (1984). 342 ancestors in all.
4 later devices descend from it; 1 cites it directly.
1 of 347 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172888: EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellular Titanium® ALIF Cages, Eit Emerging Implant Technologies GmbH (2017) Summary page 13.
- K192718: Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology, Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. (2019) Summary page 13.
- K170830: Unison-C Anterior Cervical Fixation System, Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. (2017) Summary page 13.
- K181644: EIT Cellular Titanium® Lumbar Cage LLIF, Eit Emerging Implant Technologies GmbH (2018) Summary page 13.
- 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, Centinel Spine, Inc. (2018) Summary page 13.
- (no number) HEDRON™ Cervical Spacers: named in the summary without a submission number
- (no number) Ax™ Stand-Alone ALIF System: named in the summary without a submission number
- (no number) EVOL® Spinal Interbody System: named in the summary without a submission number

## Most influential descendants
- K242260: aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM (2024), 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
- K260385: aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system (2026), 0 descendants of its own

## Indications for use
The Fortilink-A Ti is indicated for anterior interbody fusion (IBF) of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar spine from L2 to S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The IBF devices are intended to be used with FDA cleared supplemental fixation designed for the implanted level. Patients should have at least six months of non-operative treatment prior to treatment with an interbody fusion device. Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior FDA cleared supplemental fixation. The Fortilink-C Ti is intended for spinal fusion procedures at one or more levels (C2-T1) in skeletally mature patients with cervical disc disease (defined as discogenic back pain with degeneration of the disc and/or myelopathy with herniated disc and/or osteophyte formation on posterior endplates confirmed by patient history and radiographic studies), instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion at one or more levels of the cervical spine with accompanying radicular symptoms. Implants are to be packed with autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. This device is intended to be used with an FDA-cleared supplemental fixation system appropriate for use in the cervical spine. This device is intended to be used in patients who have had six weeks of non-operative treatment. The Fortilink-L Ti is indicated for lateral interbody fusion (IBF) of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar spine from L2 to S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The IBF devices are intended to be used with FDA cleared supplemental fixation designed for the implanted level. Patients should have at least six months of non-operative treatment prior to treatment with an interbody fusion device. The Fortilink-SA Ti is indicated for stand-alone anterior lumbar interbody fusion procedures in skeletally mature 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 back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The system is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and is implanted via an anterior approach. Implants must be used with three of the provided bone screws. This system is to be used in patients who have had six months of non-operative treatment. The Fortilink-SA Ti with lordotic angles greater than or equal to 20 degrees requires the use of FDA cleared supplemental fixation in addition to the screws intrinsic to the interbody spacer. The Fortilink-SC Ti is intended for stand-alone anterior cervical interbody fusion procedures at one or two levels (C2-T1) in skeletally mature patients with cervical disc disease (defined as discogenic back pain with degeneration of the disc and/or myelopathy with herniated disc and/or osteophyte formation on posterior endplates confirmed by patient history and radiographic studies), instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion at one or more levels of the cervical spine with accompanying radicular symptoms. The system is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and is implanted via an anterior approach. Implants must be used with two of the provided bone screws. This system is to be used in patients who have had six weeks of non-operative treatment. The Fortilink-TC Ti is indicated for transforaminal interbody fusion (IBF) of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar spine from L2 to S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The IBF devices are intended to be used with FDA cleared supplemental fixation designed for the implanted level. Patients should have at least six months of non-operative treatment prior to treatment with an interbody fusion device. The Fortilink-TS Ti is indicated for transforaminal and posterior interbody fusion (IBF) of the spine in skeletally mature patients with degenerative disc disease (DDD) and up to Grade 1 spondylolisthesis of the lumbar spine at one level or two contiguous levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These IBF devices are used to facilitate interbody fusion in the lumbar spine from L2 to S1 using autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The IBF devices are intended to be used with FDA cleared supplemental fixation designed for the implanted level. Patients should have at least six months of non-operative treatment prior to treatment with an interbody fusion device.

Source page: https://510kreport.com/device/K201453
Methodology: https://510kreport.com/methodology