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

Orthocon, Inc. — Predicate Candidate Screening

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

122 daysmedian FDA review time

290 days90th percentile

36clearances measured

K-number	Device	Applicant	Decided	Review days
K261265	Permatage XT Settable Bone Putty	Orthocon, Inc.	2026-06-15	60
K261439	Permatage Flowable, Settable Hemostatic Bone Paste	Orthocon, Inc.	2026-06-03	34
K253447	Montage Flowable Settable, Resorbable Bone Paste (Burr Hole	Orthocon, Inc.	2026-03-16	165
K253732	Permatage Flowable, Settable Bone Paste	Orthocon, Inc.	2026-03-13	109
K253854	MONTAGE XT Cranial Cement	Orthocon, Inc.	2026-01-02	30
K243526	MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable,	Orthocon, Inc.	2024-12-05	21
K243506	Montage-XT Settable Bone Putty	Orthocon, Inc.	2024-11-18	6
K241027	Permatage Settable Bone Putty	Orthocon, Inc.	2024-09-26	164
K233566	Montage-XT Settable, Resorbable Bone Putty	Orthocon, Inc.	2024-08-21	289
K242050	Montage Settable Bone Putty	Orthocon, Inc.	2024-07-29	17
K232771	Montage Flowable Settable, Resorbable Bone Paste	Orthocon, Inc.	2024-02-16	158
K231475	MONTAGE-QS Settable, Resorbable Bone Putty	Orthocon, Inc.	2023-10-12	143
K232998	Montage- XT Settable, Resorbable Hemostatic Bone Putty	Orthocon, Inc.	2023-10-12	20
K231270	Montage Flowable Settable, Resorbable Bone Paste	Orthocon, Inc.	2023-09-01	122
K213418	MONTAGE Settable, Resorbable Hemostatic Bone Putty	Orthocon, Inc.	2023-08-30	679
K231903	Montage-QS Settable, Resorbable Bone Putty	Orthocon, Inc.	2023-08-25	58
K231386	Montage Flowable XRO Settable, Resorbable Hemostatic Bone Pa	Orthocon, Inc.	2023-07-11	60
K222063	MONTAGE Settable, Resorbable Bone Putty	Orthocon, Inc.	2023-02-03	205
K221933	MONTAGE Settable, Resorbable Bone Putty	Orthocon, Inc.	2023-01-13	196
K220315	MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty	Orthocon, Inc.	2022-03-11	36
K202363	HBP7 Settable Hemostatic Bone Putty	Orthocon, Inc.	2021-01-19	153
K193052	HBP6 Settable, Resorbable Hemostatic Bone Paste	Orthocon, Inc.	2020-03-27	147
K191140	MONTAGE-QS Settable, Resorbable Hemostatic Bone	Orthocon, Inc.	2019-07-18	79
K153317	HEMASORBPLUS Resorbable Hemostatic Bone Putty	Orthocon, Inc.	2016-11-30	378
K152005	MONTAGE Settable, Resorbable Hemostatic Bone Putty	Orthocon, Inc.	2015-10-15	87
K143069	HEMASORBPLUS press Resorable Hemostatic Bone Putty	Orthocon, Inc.	2014-12-22	56
K141502	HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY	Orthocon, Inc.	2014-10-03	119
K140117	AHBPPRESS ABSORBABLE HEMOSTATIC BONE PUTTY	Orthocon, Inc.	2014-02-11	26
K123243	HEMASORB BONE PUTTY 3 RESORBABLE HEMOSTATIC BONE PUTTY	Orthocon, Inc.	2013-04-05	170
K122156	ORTHOCON ABSORBABLE HEMOSTATIC BONE PUTTY	Orthocon, Inc.	2013-01-28	192
K121953	HEMASORB APPLY	Orthocon, Inc.	2012-11-21	141
K111575	HEMASORB ABSORBABLE BONE HEMOSTAT MATRIX	Orthocon, Inc.	2012-05-23	352
K102762	ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR	Orthocon, Inc.	2011-02-15	144
K091121	ORTHOSTAT	Orthocon, Inc.	2009-04-28	11
K061131	DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY	Orthocon, Inc.	2007-02-08	290
K063330	ORTHOCON HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY	Orthocon, Inc.	2006-11-22	19

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