Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

PML · Predicate Candidate Screening

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

134 daysmedian FDA review time

265 days90th percentile

19clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K260286	Dynamo™ Spinal Cement; Salvo® Spine System	Spine Wave, Inc.	2026-06-15	137	0
K252885	OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spi	Astura Medical	2026-01-22	134	0
K241034	Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw Syste	Medacta International S.A.	2024-06-12	57	0
K231809	Momentum® Posterior Spinal Fixation System with G21 V-STEADY	Ulrich Medical USA	2023-10-20	122	0
K230774	PERLA® TL System; TEKTONA® HV US Bone Cement	Spineart	2023-06-23	94	0
K222789	VADER® Pedicle System, G21 Cement	Icotec AG	2023-01-09	116	2
K221926	Invictus® Bone Cement, Invictus Spinal Fixation System	Alphatec Spine, Inc.	2022-12-20	172	0
K222256	BonOs® Inject Bone Cement; NEO Pedicle Screw System™	Neo Medical SA	2022-08-26	30	0
K212489	BonOs Inject Bone Cement; NEO Pedicle Screw System	Neo Medical SA	2021-10-28	80	0
K200596	G21 Cement, VADER® Pedicle System	Icotec AG	2020-10-13	221	1
K201362	CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System	Medtronic	2020-08-19	89	0
K192818	Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augm	Stryker Corporation	2020-03-31	182	0
K190526	High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws	CarboFix Orthopedics , Ltd.	2019-09-19	199	0
K191148	Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD	Medtronic Sofamor Danek USA, Inc.	2019-09-12	135	0
K180498	NuVasive Reline Fenestrated Screws, High V+ Bone Cement	Nu Vasive, Incorporated	2018-11-28	275	0
K172269	FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plu	Globus Medical, Inc.	2018-03-27	242	0
K171938	KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set	Medtronic	2017-10-23	117	0
K160879	CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIU	Medos International Sàrl	2016-12-20	265	0
K152604	KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated	Medtronic Sofamor Danek USA, Incorporated	2016-01-06	117	0

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