Product code GXP— Neurology
BONESOURCE HYDROXYAPATITE CEMENT (HAC)
- Classification name
- Methyl Methacrylate For Cranioplasty
- Device class
- Class 2
- Regulation
- 21 CFR 882.5300
- Advisory panel
- Neurology
- Total cleared
- 45
- First cleared
- Most recent
Market context for product code GXP
FDA has cleared devices under product code GXP between 1987 and 2026, filed by 26 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2024
- 2023
- 2019
- 2017
- 2015
- 2010
- 2009
- 2007
- 2006
- 2005
- 2004
- 2003
- 2002
- 2001
Top applicants under product code GXP
Recent clearances under product code GXP
- K251959 — TnR Cranial Implant
- K261265 — Permatage XT Settable Bone Putty
- K253732 — Permatage Flowable, Settable Bone Paste
- K253854 — MONTAGE XT Cranial Cement
- K241027 — Permatage Settable Bone Putty
- K232771 — Montage Flowable Settable, Resorbable Bone Paste
- K231475 — MONTAGE-QS Settable, Resorbable Bone Putty
- K221933 — MONTAGE Settable, Resorbable Bone Putty
- K182742 — DB-CMF
- K162864 — OsteoVation Impact
- K143661 — DirectInject
- K102018 — NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY
- K091382 — KRYPTONITE BONE CEMENT
- K070012 — POLYBONE
- K072601 — OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT
- K071791 — MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280
- K060763 — STRYKER INJECTABLE CEMENT
- K060443 — NORIAN CRS FAST SET PUTTY
- K060445 — NORIAN CRS BONE CEMENT
- K051093 — OSTEOPORE PCL SCAFFOLD
- K051784 — OSTEOVATION CMF BONE VOID FILLER
- K043334 — BONE SOURCE HAC RAPID SETTING CEMENT
- K042414 — VISIOPLAST ACRYLIC RESIN
- K043280 — MIMIX MP BONE VOID FILLER
- K042072 — CALLOS CMF BONE VOID FILLER
- K041350 — SYNTHES (USA) CHRONOS
- K040152 — BONE CEMENT FOR CRANIOPLASTY
- K032366 — BONESOURCE HAC FAST SETTING CEMENT
- K032307 — CAP BONE SUBSTITUTE MATERIAL
- K011399 — BIOMET CRANIOFACIAL ACRYLIC CEMENT
- K023575 — CONCERT CRANIOPLAST
- K023718 — QUICKSET MIMIX BONE VOID FILLER
- K021440 — BONESOURCE HAC
- K012589 — FAST SET PUTTY
- K011736 — DRG QUICKMIX
- K012569 — MODIFICATION TO: INJECTABLE MIMIX
- K994022 — PARALLAX CRANIOSET
- K990290 — CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER
- K991398 — BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT
- K983009 — BSM- BONE SUBSTITUTE MATERIAL
- K982040 — MEDPOR SURGICAL GRANULE IMPLANTS
- K973789 — NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CC
- K964537 — BONESOURCE HYDROXYAPATITE CEMENT (HAC)
- K953339 — BONESOURCE HYDROXYAPATITE CEMENT (HAC)
- K873689 — CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL
Data sourced from openFDA. This site is unofficial and independent of the FDA.