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

KWS — Predicate Candidate Screening

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

98 daysmedian FDA review time

214 days90th percentile

191clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K260721	Tornier Perform Advanced Glenoid	Tornier, Inc.	2026-07-22	139	0
K254084	AETOS Shoulder System - CONCELOC Glenoids	Smith & Nephew, Inc.	2026-04-06	109	0
K252418	Catalyst F1x Shoulder System	Catalyst Orthoscience, Inc.	2025-11-06	97	0
K252416	AETOS Shoulder System Meta Humeral Prosthesis Size 0	Smith & Nephew, Inc.	2025-10-29	89	0
K241292	MyShoulder Planner (5.3SSWPL)	Medacta International S.A.	2025-01-30	267	0
K241878	Tornier Humeral Reconstruction System (Tornier HRS); Tornier	Stryker Corporation (Tornier, Inc.)	2024-12-06	161	0
K241609	Tornier Humeral Reconstruction System (Tornier HRS)	Stryker Corporation (Tornier, Inc.)	2024-09-10	97	0
K230513	Arthrex Univers Apex OptiFit Humeral Stem	Arthrex, Inc.	2023-09-26	214	0
K222592	AltiVate® Anatomic Shoulder AG e+™ with Markers	Encore Medical L.P.	2023-06-23	301	0
K230572	AETOS Shoulder System	Smith & Nephew, Inc.	2023-06-07	98	0
K220847	AETOS Shoulder System	Smith & Nephew, Inc.	2023-01-03	286	0
K222317	Catalyst EA Convertible Stemmed Shoulder	Catalyst Orthoscience, Inc.	2022-11-10	100	0
K213387	AltiVate® Anatomic Shoulder AG e+™ with Markers	Encore Medical L.P.	2022-07-07	266	0
K213785	SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid	Limacorporate	2022-05-13	158	0
K213827	TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder Sy	Smith & Nephew, Inc.	2022-03-11	93	0
K212356	Exactech® Equinoxe® Laser Cage Glenoid	Exactech, Inc.	2022-03-04	218	1
K212435	Comprehensive Humeral Fracture Positioning Sleeves	Biomet, Inc.	2021-12-10	128	0
K210861	ReUnion Reversible Fracture System (RFX), ReUnion Reverse Sh	Stryker GmbH	2021-09-03	164	0
K210050	Augmented VaultLock Glenoid	Arthrex, Inc.	2021-06-07	150	0
K203315	BLUEPRINT™ Patient Specific Instrumentation	Tornier S.A.S.	2021-04-15	156	0
K203230	Global Shoulder and Delta CTA systems	Depuy Lnc.	2021-04-02	151	0
K203026	AltiVate® Anatomic Pegged Glenoid with Markers	Encore Medical L.P.	2020-12-23	82	0
K202289	ReUnion Reversible Fracture System (RFX), ReUnion Reverse Sh	Stryker GmbH	2020-12-16	126	0
K193180	Alliance Augmented Glenoid	Zimmer, Inc.	2020-02-24	98	0
K191247	SmartSPACE Shoulder System	Techmah Medical, LLC	2019-11-15	190	0
K191814	Alliance Glenoid	Zimmer, Inc.	2019-10-23	110	0
K190286	Materialise Glenoid Positioning System	Materialise NV	2019-07-08	147	0
K191318	AEQUALIS FLEX REVIVE Shoulder System	Tornier, Inc.	2019-06-14	30	2
K190521	Aequalis Ascend Flex Shoulder System	Tornier S.A.S.	2019-06-12	100	0
K190290	AltiVate Reverse Humeral Stem, 48mm	Encore Medical L.P.	2019-04-26	74	0
K182799	Arthrex Univers II Shoulder Prosthesis System: Titanium Hume	Arthrex, Inc.	2019-03-08	157	0
K183039	ReUnion Reversible Fracture System (RFX), ReUnion Reverse Sh	Stryker GmbH	2019-02-15	106	0
K183042	SMR Lateralized Connectors with screws	Lima Corporate S.P.A.	2019-01-25	84	0
K181555	Arthrex Fracture Adapter Hemi Shoulder Prosthesis	Arthrex, Inc.	2018-12-21	191	0
K181742	ReUnion Reversible Fracture System (RFX), ReUnion Reverse Sh	Stryker GmbH	2018-09-27	87	0
K181420	Aequalis Flex Revive Shoulder System	Tornier, Inc.	2018-09-20	112	0
K171841	Arthrex Shoulder System	Arthrex, Inc.	2018-03-29	282	0
K172054	Materialise Glenoid Positioning System	Materialise NV	2017-11-03	120	0
K172351	AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer	Encore Medical L.P.	2017-10-30	88	2
K172210	ReUnion Reversible Fracture System (RFX), ReUnion Reverse Sh	Stryker Trauma AG	2017-10-02	70	0
K170910	Medacta Anatomic Shoulder Prosthesis	Medacta International S.A.	2017-08-16	141	0
K170893	Materialise Glenoid Positioning System	Materialise NV	2017-06-19	84	0
K162800	BLUEPRINT Patient Specific Instrumentation	Tornier S.A.S.	2017-02-22	140	0
K162697	Arthrex Glenoid Intelligent Reusable Instrument System, Arth	Custom Orthopaedic Solutions, Inc.	2017-02-10	136	0
K161789	BLUEPRINT Patient Specific Instrumentation	Tornier S.A.S.	2016-12-27	181	0
K161863	ReUnion Reversible Fracture System (RFX), ReUnion Reverse Sh	Stryker GmbH	2016-11-23	140	0
K162024	AltiVate Anatomic Shoulder System	Encore Medical L.P.	2016-11-21	122	0
K161108	Arthrex VaultLock Glenoid	Arthrex, Inc.	2016-08-29	131	0
K160555	BLUEPRINT Patient Specific Instrumentation	Tornier S.A.S.	2016-06-10	102	0
K160975	Aequalis PerFORM+ Shoulder System	Tornier, Inc.	2016-06-10	64	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