# K180590: Tyber Medical PT Interbody Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Tyber Medical, LLC
- Decided: Jul 6, 2018 after 122 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- 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: 19 generations back to K841189 (1984). 270 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 277 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172185: Tyber Medical PT Interbody Spacer System, Tyber Medical, LLC (2017) Summary page 4.
- K151773: CONCORDE Bullet Lumbar Interbody System, Medos International SARL (2015) Summary page 4.
- K132421: Aesculap Peek XP Spinal Implant System, Aesculap Implant Systems, Inc. (2014) Summary page 4.
- K162358: T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System, Synthes USA Products, LLC (2016) Summary page 4.
- K133653: Anatomic Peek PTC Cervical Fusion System, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 4.

## Most influential descendants
- K182284: Tyber Medical PT Interbody Spacer (2019), 5 descendants of its own
- K230583: Tryptik Ti (2023), 1 descendant of its own
- K192897: icotec Cervical Cage (2020), 1 descendant of its own
- K250605: EVOL® ha – Hyper C Cervical Interbody Fusion System (2025), 0 descendants of its own
- K240699: SCARLET® AC-Ti (2024), 0 descendants of its own

## Indications for use
Cervical System Indications: The Tyber Medical PT Interbody Spacer System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. Cervical implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device, supplemental fixation must be used. Lumbar System Indications: The Tyber Medical PT Interbody Spacer System is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may also have had a previous non-fusion spinal surgery at the involved spinal level(s). Additionally, the Tyber Medical PT Interbody System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. Patients should have six weeks of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a posterior, transforaminal, lateral or anterior approach using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as interbody fusion devices these implants are intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.

Source page: https://510kreport.com/device/K180590
Methodology: https://510kreport.com/methodology