510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K142114Substantially Equivalent

Xia® Growth Rod Conversion Set

Stryker Corp., Allendale NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K142114 is the FDA 510(k) clearance record for Xia® Growth Rod Conversion Set, a class II device, cleared for Stryker Corporation on under FDA product code PGM (Growing Rod System). FDA's definition for product code PGM reads: "Stabilization or correction of spinal deformities without the use of fusion". FDA records list 568 510(k) clearances for Stryker Corporation, from to . As of , FDA records show no recalls naming K142114.

Clearance record

Decision date
Received
(84 days to decision)
Product code
PGM Growing Rod System
Regulation
21 CFR 888.3070
Device class
Class II
Review panel
Orthopedic
Applicant
Stryker Corporation 2 Pearl Ct., Allendale NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PGM

Trailing 12 months
1 clearance under product code PGM in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PGM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260