Product code MQP: 510(k) clearances and predicates

Product code MQP covers Vertiwedge® Intraosseous System. FDA lists 279 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.

Clearance volume

279 clearances on file under product code MQP. Counts by year:

YearClearances
20221
20231
20244
20250
2026 so far3

Recent clearances

Newest MQP clearances in the FDA index, with applicant and decision date:

  • K261810, Vertiwedge® Intraosseous System, applicant Foundation Surgical Group, decided 2026-07-31. FDA record
  • K261031, POSEIDON ST, applicant Signus Medinzintechnik GmbH, decided 2026-07-10. FDA record
  • K253158, VyBrate™ VBR System, applicant Vy Spine, LLC, decided 2026-01-07. FDA record
  • K241468, Vertiwedge® Intraosseous System, applicant Foundation Surgical Group, Inc., decided 2024-11-07. FDA record
  • K232790, KONG®-TL VBR System and KONG® C VBR System, applicant Icotec AG, decided 2024-04-04. FDA record
  • K233359, DOMINION Expandable Corpectomy System, applicant Astura Medical, decided 2024-03-08. FDA record
  • K231134, VerteLoc Spinal System, applicant Signature Orthopaedics Pty, Ltd., decided 2024-02-13. FDA record
  • K232173, Ascend VBR System, Ascend NanoTec VBR System, applicant Alphatec Spine, Inc., decided 2023-10-06. FDA record

What this means for a regulatory watcher

Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include POSEIDON ST, VyBrate™ VBR System. Watch new MQP clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.

FAQ

What is FDA product code MQP?

It is the three letter code FDA assigns to a device type in the 510(k) index. Recent MQP clearances include Vertiwedge® Intraosseous System.

How many 510(k) clearances use product code MQP?

279 at the time this page was generated, from openFDA records.

How do I find a predicate device under MQP?

Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.

How do I track new MQP clearances?

Get 510(k) alerts filtered to this product code and read each new clearance as it posts.

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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.