Cleared Traditional

SDS Growing Rod (K251961) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251961 · BAAT Medical Products B.V. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2026
Decision
203d
Days
Class 2
Risk

K251961 is an FDA 510(k) clearance for the SDS Growing Rod. Classified as Growing Rod System (product code PGM), Class II - Special Controls.

Submitted by BAAT Medical Products B.V. (Hengelo, NL). The FDA issued a Cleared decision on January 15, 2026 after a review of 203 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all BAAT Medical Products B.V. devices

Submission Details

510(k) Number K251961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2025
Decision Date January 15, 2026
Days to Decision 203 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 122d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PGM Growing Rod System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Stabilization Or Correction Of Spinal Deformities Without The Use Of Fusion.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - PGM Growing Rod System

All 13
Devices cleared under the same product code (PGM) and FDA review panel - the closest regulatory comparables to K251961.
VerteGlide Spinal Growth Guidance System
K241816 · OrthoPediatrics Corp. · Mar 2025
MARVEL™ Growing Rods
K213196 · Globus Medical, Inc. · Dec 2022
Daytona® Small Stature Growth Rod Conversion Set
K193224 · SeaSpine Orthopedics Corporation · Feb 2020
CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System
K191212 · Medos International SARL · Sep 2019
CREO® Stabilization System, REVERE® Stabilization System
K181068 · Globus Medical, Inc. · Jun 2018
Polaris Spinal Growth System
K180227 · Zimmer Biomet Spine, Inc. · Mar 2018