510(k) · Cleared
ClearedUNiTi ACDF Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pressio, Inc. · PHQ Anterior Staple As Supplemental Fixation For Fusion
Cleared on Feb 3, 2021 as substantially equivalent to K133906 (Medicrea International, 2014) and 1 other predicate after a 363-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- Feb 3, 2021
- Review
- 363 days
- Class
- Class II
- Product code
- PHQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K914362 (1992). 10 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet.
- Root · 3 generations backK914362 Top Cervical Spine Plates & Titanium Bone ScrewsAcorn Group, Inc. · 1992
- 2 generations backK042544 Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc. · 2004
- 1 generation backK133906 C-Jaws Cervical Compressive StapleMedicrea International · 2014
- This deviceK200301 UNiTi ACDF Implant SystemPressio, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K914362 | Top Cervical Spine Plates & Titanium Bone Screws | Acorn Group, Inc. | 1992 | — |
| −2 | K042544 | Uniplate Anterior Cervical Plate System | Depuy Spine, Inc. | 2004 | — |
| −1 | K133906 | C-Jaws Cervical Compressive Staple | Medicrea International | 2014 | — |
| 0 (this device) | K200301 | UNiTi ACDF Implant System | Pressio, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 2 | 0 |
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PHQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K133906 | C-Jaws Cervical Compressive StapleSummary page 5…mance Data Table 5-1 Predicate Devices 510k Number Trade or Proprietary or Manufacturer Predicate Type Model Name K133906 C-JAWS Cervical Medicrea Primary Compressive Staple… | 2014 |
| * | K141332 | Captiva Spine SmartLOX Cervical Plate SystemSummary page 5…Model Name K133906 C-JAWS Cervical Medicrea Primary Compressive Staple International K141332 SmartLOX Cervical Plate Captiva Spine Additional System K142041… | 2015 |
| † | K142041 | Porosteon Phusion Metal Cervical Cage | 2014 |
| † | K150125 | Elite Nitinol Fixation System | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 9.7 years on median.
- 1 of the 10 ancestors has a recall of any class.
How does its category compare?
All PHQ devicesPHQ Anterior Staple As Supplemental Fixation For Fusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · PHQ
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · PHQ
Too few PHQ 510(k)s in any year since 2007 to give a median.
Recalls per year · PHQ
No recall names PHQ since 2007.
Adverse event reports per year · PHQ
1in 2023
MAUDE reports naming product code PHQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (165 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200301 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200301: UNiTi ACDF Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200301
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026