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FDA product code · Orthopedic · Class 2

MQP: Spinal Vertebral Body Replacement Device

MQP is FDA's product code for "Spinal Vertebral Body Replacement Device": a Class 2 device classified under 21 CFR 888.3060, reviewed by the Orthopedic panel. FDA flags it as an implant.

510(k) review time for MQP

Across 26 510(k) clearances under MQP decided from 2018-01-01 to 2026-10-06, the median was 121 days from FDA receipt to decision. Half took between 80 and 196 days, and 80% were decided within 206 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, MQP, decisions 2018-01-01 to 2026-10-06 (n = 26)
Fastest29
25th percentile80
Median121
75th percentile196
80th percentile206
90th percentile262
Slowest472
Median days by decision year, MQP (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
20181526
2019938

Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.

MQP in the public FDA record

Records naming MQP, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years279
Device recalls46
Establishment listings1,186
GUDID device identifiers34,616

Counts of records, not of devices or events. Adverse event reports for MQP are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.

FDA-recognized standards that cite MQP

15 FDA recognized consensus standards cite MQP, among them ASTM F2267-04 (Reapproved 2018); ASTM F983-86 (Reapproved 2018); ASTM F565-04 (Reapproved 2018). Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 11-185 ASTM F2267-04 (Reapproved 2018) — Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
  • 11-197 ASTM F983-86 (Reapproved 2018) — Standard Practice for Permanent Marking of Orthopaedic Implant Components
  • 11-199 ASTM F565-04 (Reapproved 2018) — Standard Practice for Care and Handling of Orthopedic Implants and Instruments
  • 11-347 ASTM F2077-18 — Test Methods for Intervertebral Body Fusion Devices
  • 11-369 ASTM F3292-19 — Standard Practice for Inspection of Spinal Implants Undergoing Testing
  • 11-421 ASTM F2077-24 — Standard Test Methods for Intervertebral Body Fusion Devices
  • 11-423 ASTM F2267-24 — Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
  • 11-424 ASTM F983-24 — Standard Practice for Permanent Marking of Orthopaedic Implant Components
  • 11-425 ASTM F565-21 — Standard Practice for Care and Handling of Orthopedic Implants and Instruments
  • 11-435 ASTM F3292-25 — Standard Practice for Inspection of Spinal Implants Undergoing Testing
  • 8-475 ASTM F2026-17 — Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
  • 8-558 ASTM F3333-20 — Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
  • 8-574 ASTM F2820-12(2021)e1 — Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications
  • 8-609 ASTM F2026-23 — Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
  • 8-643 ASTM F2820-24 — Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications

Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.

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