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

Exactech, Inc. — Predicate Candidate Screening

186 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

87 daysmedian FDA review time

269 days90th percentile

186clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K260583	Equinoxe® Shoulder System	Exactech, Inc.	2026-04-14	53	0
K250713	Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Steml	Exactech, Inc.	2025-12-01	266	0
K243448	Equinoxe® Shoulder System	Exactech, Inc.	2025-08-01	267	0
K243275	Equinoxe® Scapula Fracture System	Exactech, Inc.	2025-06-26	253	0
K243839	Alteon® HA Femoral Stems	Exactech, Inc.	2025-03-10	87	0
K240393	Exactech® TRULIANT® Knee System	Exactech, Inc.	2024-10-03	238	0
K233482	Equinoxe® Central Screw Baseplate System	Exactech, Inc.	2024-07-18	266	0
K230717	Exactech® Vantage® Total Ankle System	Exactech, Inc.	2023-10-12	211	0
K223933	Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws	Exactech, Inc.	2023-09-25	269	0
K223833	Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapt	Exactech, Inc.	2023-09-14	266	1
K232002	Vantage® Total Ankle System	Exactech, Inc.	2023-09-11	68	0
K223252	TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas	Exactech, Inc.	2023-07-17	269	1
K221323	Exactech® Alteon® Short Tapered Wedge	Exactech, Inc.	2023-05-19	378	0
K212356	Exactech® Equinoxe® Laser Cage Glenoid	Exactech, Inc.	2022-03-04	218	1
K192097	Exactech® Equinoxe® Stemless Humeral Components	Exactech, Inc.	2020-04-29	268	0
K193098	Exactech® Equinoxe® Reverse Shoulder Glenospheres	Exactech, Inc.	2020-02-20	105	0
K190890	Exactech Alteon Modular Dual Mobility (MDM) System	Exactech, Inc.	2019-10-22	200	0
K191561	Exactech Equinoxe Humeral Augmented Trays	Exactech, Inc.	2019-08-20	68	0
K183343	Vantage Total Ankle Flat Cut Talar Components	Exactech, Inc.	2019-04-01	119	0
K182502	Alteon Acetabular Cup System	Exactech, Inc.	2019-03-13	182	2
K182346	TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws	Exactech, Inc.	2018-11-26	90	0
K182462	Exactech Alteon Highly Polished Femoral Stem	Exactech, Inc.	2018-11-08	59	0
K182536	Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exac	Exactech, Inc.	2018-10-12	28	3
K181794	Truliant Porous Femoral Components	Exactech, Inc.	2018-09-28	85	0
K181532	Exactech Alteon Monobloc Revision Stem	Exactech, Inc.	2018-09-04	85	0
K180632	Exactech Equinoxe Small Reverse Shoulder System	Exactech, Inc.	2018-07-25	135	3
K173583	Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners	Exactech, Inc.	2018-03-12	112	3
K173388	Exactech Equinoxe Stemless Shoulder	Exactech, Inc.	2018-03-09	130	0
K171045	Exactech® Truliant™ Line Extensions	Exactech, Inc.	2017-04-28	21	2
K162732	Exactech® Alteon® HA Femoral Stem	Exactech, Inc.	2017-04-26	209	1
K162325	Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equ	Exactech, Inc.	2017-03-06	199	0
K162903	Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Sm	Exactech, Inc.	2017-02-27	133	0
K170240	Truliant Femoral Components	Exactech, Inc.	2017-02-23	28	0
K162726	Exactech® Equinoxe® Preserve Stem	Exactech, Inc.	2017-02-01	125	0
K153649	Exactech® Novation® Element Press-fit Femoral Stem	Exactech, Inc.	2016-08-31	254	0
K160697	Gibralt® Spine System and Gibralt® Occipital Spine System	Exactech, Inc.	2016-06-28	106	0
K153595	Optetrak Logic Metaphyseal Cones	Exactech, Inc.	2016-03-25	100	0
K160484	Optetrak Advanced Patella	Exactech, Inc.	2016-03-18	25	5
K152217	Exactech Vantage Total Ankle System	Exactech, Inc.	2016-03-10	216	2
K153776	Optetrak One Logic Femoral Components	Exactech, Inc.	2016-03-10	70	0
K141960	Exactech® Novation® Crown Cup®	Exactech, Inc.	2015-09-03	412	0
K152170	Exactech Optetrak Logic Enhanced Assembly	Exactech, Inc.	2015-09-03	30	2
K150066	Exactech Alteon Monobloc Revision Stem	Exactech, Inc.	2015-07-20	188	0
K150890	Exactech Optetrak Logic CC	Exactech, Inc.	2015-05-29	57	2
K150130	Ascendant TM Cervical Spacer System	Exactech, Inc.	2015-05-28	127	0
K150458	Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere	Exactech, Inc.	2015-05-14	80	0
K150152	The Octane Straight Intervertebral Fusion Device, Ti Coated	Exactech, Inc.	2015-05-11	108	0
K143659	Equinoxe Mega Prosthesis	Exactech, Inc.	2015-04-09	107	0
K143576	Exactech Ambassador	Exactech, Inc.	2015-02-27	72	1
K141821	ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6	Exactech, Inc.	2014-08-28	52	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