510(k) Report

FDA product code · Orthopedic

Anterior Staple As Supplemental Fixation For Fusion

PHQClass II21 CFR 888.3060510(k) required2 decisions since 20140 recalls

2 FDA decisions since 2014. 510(k) reviews decided 2021–2025 took a median of 363 days (half between 363 and 363). No recall names this code. The most-cited predicate is K133906, named by 1 later device.

Anterior cervical device for supplemental fixation to support a fusion.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, orthopedic panel

Twenty years of PHQ at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · PHQ

1in 2021

2014: 12021: 1
2007high 1 (2014) · low 0 (2007)2026

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

2023: 1
2007high 1 (2023) · low 0 (2007)2025

MAUDE reports naming product code PHQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20141—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20211—00
20220—00
20230—01
20240—00
20250—00
20260—0—
FIG. 1 — PHQ by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PHQ? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do PHQ devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K133906C-Jaws Cervical Compressive StapleMedicrea International · 20141cites it

Which PHQ devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K200301UNiTi ACDF Implant SystemPressio, Inc. · 20213generations
  • K133906C-Jaws Cervical Compressive StapleMedicrea International · 20142generations

What has FDA decided in PHQ lately?

  • K200301UNiTi ACDF Implant SystemPressio, Inc. · 2021
  • K133906C-Jaws Cervical Compressive StapleMedicrea International · 2014

All 2 PHQ decisions →

Related product codes

Other codes under 21 CFR 888.3060.

MQP Spinal Vertebral Body Replacement DeviceJDN Implant, Fixation Device, SpinalOJM Resorbable Spinal Intervertebral Body Fixation…OJB Resorbable Spinal Intervertebral Body Fixation…PLR Spinal Vertebral Body Replacement Device -…KWQ Appliance, Fixation, Spinal Intervertebral Body