# K200301: UNiTi ACDF Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Pressio, Inc.
- Decided: Feb 3, 2021 after 363 days
- Product code: PHQ (Anterior Staple As Supplemental Fixation For Fusion)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K914362 (1992). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133906: C-Jaws Cervical Compressive Staple, Medicrea International (2014) Summary page 5.
- K141332: Captiva Spine SmartLOX Cervical Plate System, Captiva Spine (2015) Summary page 5.

## Indications for use
The UNiTi ACDF Implant System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients as part of an anterior cervical fusion procedure for the indications listed below. The intended levels for treatment range from C3 to C7. Indications are limited to patients with degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), at one level, with radiculopathy and/or myelopathy with herniated disc producing symptomatic nerve root and or spinal compression confirmed by radiographic studies and/or with osteophyte formation on the posterior vertebral endplates producing symptomatic nerve root and or spinal compression confirmed by radiographic studies. The UNiTi ACDF Implant System is limited to one level fusion. A single UNiTi Implant must be implanted per functional segment unit fused. It MUST be used with a cervical interbody fusion device filled with autograft. Warning: This device is not approved for attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Source page: https://510kreport.com/device/K200301
Methodology: https://510kreport.com/methodology