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510(k) K253732

Permatage Flowable, Settable Bone Paste by Orthocon, Inc. — Product Code GXP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2026
Date Received
November 24, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Methyl Methacrylate For Cranioplasty
Device Class
Class II
Regulation Number
882.5300
Review Panel
NE
Submission Type

Other clearances by Orthocon, Inc.

  • K253854 — MONTAGE XT Cranial Cement (January 2, 2026)
  • K243526 — MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Pu (December 5, 2024)
  • K243506 — Montage-XT Settable Bone Putty (November 18, 2024)
  • K241027 — Permatage Settable Bone Putty (September 26, 2024)
  • K233566 — Montage-XT Settable, Resorbable Bone Putty (August 21, 2024)
  • K242050 — Montage Settable Bone Putty (July 29, 2024)
  • K232771 — Montage Flowable Settable, Resorbable Bone Paste (February 16, 2024)
  • K231475 — MONTAGE-QS Settable, Resorbable Bone Putty (October 12, 2023)
  • K232998 — Montage- XT Settable, Resorbable Hemostatic Bone Putty (October 12, 2023)
  • K231270 — Montage Flowable Settable, Resorbable Bone Paste (September 1, 2023)

Other clearances for product code GXP

  • K253854 — MONTAGE XT Cranial Cement (January 2, 2026)
  • K241027 — Permatage Settable Bone Putty (September 26, 2024)
  • K232771 — Montage Flowable Settable, Resorbable Bone Paste (February 16, 2024)
  • K231475 — MONTAGE-QS Settable, Resorbable Bone Putty (October 12, 2023)
  • K221933 — MONTAGE Settable, Resorbable Bone Putty (January 13, 2023)
  • K182742 — DB-CMF (June 20, 2019)
  • K162864 — OsteoVation Impact (January 13, 2017)
  • K143661 — DirectInject (September 2, 2015)
  • K102018 — NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY (September 23, 2010)
  • K091382 — KRYPTONITE BONE CEMENT (November 16, 2009)