Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

PGM — Predicate Candidate Screening

14 FDA 510(k) clearances under this product code; the 50 most recent screened below.

84 daysmedian FDA review time

263 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K251961	SDS Growing Rod	BAAT Medical Products B.V.	2026-01-15	203
K241816	VerteGlide Spinal Growth Guidance System	OrthoPediatrics Corp.	2025-03-14	263
K213196	MARVEL™ Growing Rods	Globus Medical, Inc.	2022-12-19	446
K193224	Daytona® Small Stature Growth Rod Conversion Set	SeaSpine Orthopedics Corporation	2020-02-13	83
K191212	CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw	Medos International SARL	2019-09-24	141
K181068	CREO® Stabilization System, REVERE® Stabilization System	Globus Medical, Inc.	2018-06-29	67
K180227	Polaris Spinal Growth System	Zimmer Biomet Spine, Inc.	2018-03-15	48
K172979	NuVasive® Growth Rod Conversion Set	Nu Vasive, Incorporated	2017-11-06	40
K161028	K2M Growing Spine System	K2m, Inc.	2016-07-22	101
K150200	CD HORIZON Growth Rod Conversion Set	Medtronic Sofamor Danek USA, Incorporated	2015-02-25	27
K142114	Xia® Growth Rod Conversion Set	Stryker Corporation	2014-10-27	84
K141509	ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS	Medos Sarl	2014-08-22	77
K140750	SHILLA GROWTH GUIDANCE SYSTEM	Medtronic Sofamor Danek USA, Inc.	2014-07-17	114
K133904	CD HORIZON SPINAL SYSTEM GROWTH ROD SET	Medtronic Sofamor Danek USA	2014-02-25	67

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda