| TnR Cranial Implant (K251959) | T&R BIOFAB CO., Ltd. | 2026-07-30 |
| Permatage XT Settable Bone Putty (K261265) | Orthocon, Inc. | 2026-06-15 |
| Permatage Flowable, Settable Bone Paste (K253732) | Orthocon, Inc. | 2026-03-13 |
| MONTAGE XT Cranial Cement (K253854) | Orthocon, Inc. | 2026-01-02 |
| Permatage Settable Bone Putty (K241027) | Orthocon, Inc. | 2024-09-26 |
| Montage Flowable Settable, Resorbable Bone Paste (K232771) | Orthocon, Inc. | 2024-02-16 |
| MONTAGE-QS Settable, Resorbable Bone Putty (K231475) | Orthocon, Inc. | 2023-10-12 |
| MONTAGE Settable, Resorbable Bone Putty (K221933) | Orthocon, Inc. | 2023-01-13 |
| DB-CMF (K182742) | Dimensional Bioceramics, LLC | 2019-06-20 |
| OsteoVation Impact (K162864) | Skeletal Kinetics, LLC | 2017-01-13 |
| DirectInject (K143661) | Stryker | 2015-09-02 |
| NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY (K102018) | Synthes USA Products, LLC | 2010-09-23 |
| KRYPTONITE BONE CEMENT (K091382) | Doctors Research Group, Inc. | 2009-11-16 |
| POLYBONE (K070012) | Kyung Won Medical Co., Ltd. | 2007-12-27 |
| OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT (K072601) | Osteosymbionics, LLC | 2007-12-10 |
| MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280 (K071791) | Codman & Shurtleff, Inc. | 2007-07-30 |
| STRYKER INJECTABLE CEMENT (K060763) | Stryker | 2006-09-22 |
| NORIAN CRS FAST SET PUTTY (K060443) | Synthes (Usa) | 2006-04-13 |
| NORIAN CRS BONE CEMENT (K060445) | Synthes (Usa) | 2006-04-13 |
| OSTEOPORE PCL SCAFFOLD (K051093) | Osteopore, Inc. | 2006-03-17 |
| OSTEOVATION CMF BONE VOID FILLER (K051784) | Skeletal Kinetics, LLC | 2005-07-20 |
| BONE SOURCE HAC RAPID SETTING CEMENT (K043334) | Stryker Instruments | 2005-02-09 |
| VISIOPLAST ACRYLIC RESIN (K042414) | Tecres | 2004-12-29 |
| MIMIX MP BONE VOID FILLER (K043280) | Biomet, Inc. | 2004-12-21 |
| CALLOS CMF BONE VOID FILLER (K042072) | Skeletal Kinetics, LLC | 2004-09-16 |
| SYNTHES (USA) CHRONOS (K041350) | Synthes (Usa) | 2004-07-08 |
| BONE CEMENT FOR CRANIOPLASTY (K040152) | Cardinalhealth | 2004-05-19 |
| BONESOURCE HAC FAST SETTING CEMENT (K032366) | Stryker Instruments | 2003-10-30 |
| CAP BONE SUBSTITUTE MATERIAL (K032307) | Etex Corp. | 2003-10-24 |
| BIOMET CRANIOFACIAL ACRYLIC CEMENT (K011399) | Biomet, Inc. | 2003-05-05 |
| CONCERT CRANIOPLAST (K023575) | Immedica, Inc. | 2003-01-22 |
| QUICKSET MIMIX BONE VOID FILLER (K023718) | Walter Lorenz Surgical, Inc. | 2002-12-04 |
| BONESOURCE HAC (K021440) | Stryker Instruments | 2002-08-02 |
| FAST SET PUTTY (K012589) | Synthes (Usa) | 2002-02-07 |
| DRG QUICKMIX (K011736) | Doctor'S Research Group, Inc. | 2002-01-30 |
| MODIFICATION TO: INJECTABLE MIMIX (K012569) | Biomet, Inc. | 2001-12-21 |
| PARALLAX CRANIOSET (K994022) | Parallax Medical, Inc. | 2000-08-31 |
| CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER (K990290) | Biomet, Inc. | 1999-11-18 |
| BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT (K991398) | Stryker Leibinger | 1999-09-22 |
| BSM- BONE SUBSTITUTE MATERIAL (K983009) | Etex Corp. | 1998-11-25 |
| MEDPOR SURGICAL GRANULE IMPLANTS (K982040) | Porex Surgical, Inc. | 1998-09-08 |
| NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CC (K973789) | Norian Corp. | 1998-05-18 |
| BONESOURCE HYDROXYAPATITE CEMENT (HAC) (K964537) | Osteogenics, Inc. | 1997-01-24 |
| BONESOURCE HYDROXYAPATITE CEMENT (HAC) (K953339) | Osteogenics, Inc. | 1996-06-27 |
| CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL (K873689) | Dentsply Intl. | 1987-10-26 |