SDS Growing Rod

FDA 510(k) K251961 · BAAT Medical Products B.V.

Substantially Equivalent

510(k) numberK251961

Submission

Device name
SDS Growing Rod
Applicant
BAAT Medical Products B.V.
Hengelo, NL
Received
June 26, 2025
Decision date
January 15, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PGM – Growing Rod System
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3070
Specialty
Orthopedic
Implant
Yes

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

Other 510(k)s with product code PGM

510(k)DeviceApplicantDecision
K241816VerteGlide Spinal Growth Guidance SystemPGM · Traditional OrthoPediatrics Corp.03/14/2025SE
K213196MARVEL™ Growing RodsPGM · Traditional Globus Medical, Inc.12/19/2022SE
K193224Daytona® Small Stature Growth Rod Conversion SetPGM · Traditional SeaSpine Orthopedics Corporation02/13/2020SE
K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…PGM · Traditional Medos International SARL09/24/2019SE
K181068CREO® Stabilization System, REVERE® Stabilization SystemPGM · Traditional Globus Medical, Inc.06/29/2018SE
K180227Polaris Spinal Growth SystemPGM · Traditional Zimmer Biomet Spine, Inc.03/15/2018SE
K172979NuVasive® Growth Rod Conversion SetPGM · Traditional Nu Vasive, Incorporated11/06/2017SE
K161028K2M Growing Spine SystemPGM · Traditional K2m, Inc.07/22/2016SE
K150200CD HORIZON Growth Rod Conversion SetPGM · Special Medtronic Sofamor Danek USA, Incorporated02/25/2015SE
K142114Xia® Growth Rod Conversion SetPGM · Traditional Stryker Corporation10/27/2014SE

More from Stryker Corporation

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K254176SinefixMBI · Special 03/16/2026SE
K220966SinefixMBI · Traditional 03/08/2023SE
K211474Kleiner KG2 SystemMAX · Traditional 09/14/2021SE
K201830ANSER Clavicle PinHSB · Traditional 08/27/2020SE

Questions and answers

When was SDS Growing Rod cleared by the FDA?

SDS Growing Rod (K251961) received a 510(k) decision of Substantially Equivalent on January 15, 2026, 203 days after the submission was received.

What is the product code of K251961?

The FDA product code is PGM – Growing Rod System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.