# Orthocon, Inc.

- Location (FDA's records): Irvington, NY
- FDA decisions: 40 (2005–2026): 40 510(k) clearances
- Names in FDA's records: Orthocon, Inc. (37); Orthocon, LLC (2); Orthocon (1)
- Product codes: MTJ (24), GXP (7), MQV (7), MBP (1), GXR (1)
- 510(k) review time since 2016: median 60 days, against 74 for FDA's reviews in the same codes and years (8 of 13 faster)
- Predicates its devices cite: 75 (46 its own); citations of its devices by later devices: 50 (46 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ceremed, Inc.: 5 (https://510kreport.com/company/ceremed)
- Cp Medical: 4 (https://510kreport.com/company/cp-medical)
- Stryker Corp.: 4 (https://510kreport.com/company/stryker)
- United States Surgical, A Division of Tyco Healthc: 3 (https://510kreport.com/company/united-states-surgical-a-division-of-tyco-healthc)
- Skeletal Kinetics, LLC: 2 (https://510kreport.com/company/skeletal-kinetics)
- Orthovita, Inc.: 2 (https://510kreport.com/company/orthovita)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)
- Lukens Corp.: 1 (https://510kreport.com/company/lukens)

## Firms that cite its devices most
- Hemostasis, LLC: 2 (https://510kreport.com/company/hemostasis)
- Marine Polymer Technologies, Inc.: 1 (https://510kreport.com/company/marine-polymer-technologies)
- Cp Medical: 1 (https://510kreport.com/company/cp-medical)

## Its most-cited devices
- K043260: Orthocon LLC Orthostat Hemostatic Bone Putty (2005), cited by 7
- K152005: MONTAGE Settable, Resorbable Hemostatic Bone Putty (2015), cited by 5
- K141502: HBP4 Hardening, Resorbable Hemostatic Bone Putty (2014), cited by 4
- K102762: Orthostat Bone Hemostat Matrix Applicator (2011), cited by 4
- K123243: Hemasorb Bone Putty 3 Resorbable Hemostatic Bone Putty (2013), cited by 3
- K091121: Orthostat (2009), cited by 3

## Recent decisions
- K262769: Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT) (Sep 3, 2026)
- K261265: Permatage XT Settable Bone Putty (Jun 15, 2026)
- K261439: Permatage Flowable, Settable Hemostatic Bone Paste (Jun 3, 2026)
- K253447: Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) (Mar 16, 2026)
- K253732: Permatage Flowable, Settable Bone Paste (Mar 13, 2026)
- K253854: MONTAGE XT Cranial Cement (Jan 2, 2026)
- K243526: MONTAGE Settable, Resorbable Bone Putty  MONTAGE-QS Settable, Resorbable Bone Putty  MONTAGE Flowable Settable, Resorbable Bone Paste  MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty (Dec 5, 2024)
- K243506: Montage-XT Settable Bone Putty (Nov 18, 2024)

Source page: https://510kreport.com/company/orthocon