510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K093442Substantially Equivalent

Guided Growth System

Orthofix SRL, Mckinney TX / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093442 is the FDA 510(k) clearance record for GUIDED GROWTH SYSTEM, a class II device, cleared for Orthofix, Inc. on under FDA product code OBT (Plate, Bone, Growth Control, Pediatric, Epiphysiodesis). FDA's definition for product code OBT reads: "Intended to redirect the angle of growth of long bone(s) only in pediatric patients. Indicated for temporary or permanent epiphysiodesis. For gradually correcting angular deformities of long bones in pediatric patients with an open physis...". FDA records list 102 510(k) clearances for Orthofix, Inc., from to . As of , FDA records show no recalls naming K093442.

Clearance record

Decision date
Received
(217 days to decision)
Product code
OBT Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Orthofix, Inc. 1720 Bray Central Dr., Mckinney TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OBT

Trailing 12 months

FDA records hold no clearances under product code OBT in the trailing twelve months.

FDA records show no clearances under product code OBT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OBT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260