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510(k) K142114

Xia® Growth Rod Conversion Set by Stryker Corporation — Product Code PGM

K142114 is an FDA 510(k) premarket notification submitted by Stryker Corporation for the device "Xia® Growth Rod Conversion Set". The FDA issued a decision of Substantially Equivalent on October 27, 2014. The device falls under product code PGM (Growing Rod System), a Class II device regulated under 21 CFR 888.3070. Stryker Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2014
Date Received
August 4, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Growing Rod System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Stabilization or correction of spinal deformities without the use of fusion.

Other clearances by Stryker Corporation

  • K232157 — Connected OR Hub with Device and Voice Control, SDC4K Information Management Sys (August 18, 2023)
  • K212194 — Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker an (February 16, 2023)
  • K223770 — Sonopet 1Q 3 7cm 1Q Large (February 16, 2023)
  • K221728 — Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ A (October 19, 2022)
  • K221074 — OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Devic (September 16, 2022)
  • K221098 — Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Ele (July 12, 2022)
  • K213824 — Sonopet iQ Ultrasonic Aspirator System (February 3, 2022)
  • K212055 — Connected OR Hub with Device and Voice Control (December 16, 2021)
  • K210377 — Stryker iBur hubs and cutting accessories (June 30, 2021)
  • K202964 — iBed Wireless with iBed Mobile (June 18, 2021)

Other clearances for product code PGM

  • K251961 — SDS Growing Rod (January 15, 2026)
  • K241816 — VerteGlide Spinal Growth Guidance System (March 14, 2025)
  • K213196 — MARVEL™ Growing Rods (December 19, 2022)
  • K193224 — Daytona® Small Stature Growth Rod Conversion Set (February 13, 2020)
  • K191212 — CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fen (September 24, 2019)
  • K181068 — CREO® Stabilization System, REVERE® Stabilization System (June 29, 2018)
  • K180227 — Polaris Spinal Growth System (March 15, 2018)
  • K172979 — NuVasive® Growth Rod Conversion Set (November 6, 2017)
  • K161028 — K2M Growing Spine System (July 22, 2016)
  • K150200 — CD HORIZON Growth Rod Conversion Set (February 25, 2015)

FDA data resources