GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN

K101557 · Etex Corp. · MQV · Jul 1, 2010 · Orthopedic

Device Facts

Record IDK101557
Device NameGAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN
ApplicantEtex Corp.
Product CodeMQV · Orthopedic
Decision DateJul 1, 2010
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 888.3045
Device ClassClass 2
AttributesTherapeutic

Indications for Use

Beta-bsm Injectable Bone Substitute Material is an implantable bone graft that is a synthetic calcium phosphate, poorly crystalline hydroxyapatite material intended for use in filling bone voids or defects of the skeletal system (i.e. the extremities, posterolateral spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Beta-bsm Injectable Bone Substitute Material is a bone graft substitute that resorbs and is replaced with new bone during the healing process. Gamma-bsm Moldable Bone Substitute Material is an implantable bone graft that is a synthetic calcium phosphate, poorly crystalline hydroxyapatite material intended for use in filling bone voids or defects of the skeletal system (i.e. the extremities, posterolateral spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Gamma-bsm Moldable Bone Substitute Material is a bone graft substitute that resorbs and is replaced with new bone during the healing process. CarriGen Porous Bone Substitute Material is an injectable, self setting, macro-porous, osteo-conductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e. posterolateral spine), and the pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. CarriGen is a bone graft substitute that resorbs and is replaced with new bone during the healing process. EquivaBone is a bone graft substitute that combines synthetic calcium phosphate and demineralized bone. It is resorbed and replaced with new bone during the healing process. It is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e. posterolateral spine) and pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Device Story

Synthetic, biocompatible bone graft substitutes; supplied as powder and mixing solution. Components mixed in OR to form paste or putty; applied manually or via syringe. Material hardens in-situ at body temperature; converts to poorly crystalline hydroxyapatite (PCHA). Osteoconductive; resorbed and replaced by natural bone. EquivaBone includes human demineralized bone matrix (DBM) assayed for osteoinductive potential. Used by surgeons to fill non-structural skeletal voids/defects.

Clinical Evidence

Bench testing only. Regression testing performed per Class II Special Controls Guidance Document for Resorbable Calcium Salt Bone Void Filler Devices to confirm proposed changes do not alter risk profile. EquivaBone DBM component assayed for osteoinductive potential in athymic nude mouse model.

Technological Characteristics

Synthetic calcium phosphate, sodium carboxymethyl cellulose (CMC), sodium carbonate, sodium bicarbonate, and human demineralized bone matrix (DBM). Hardens at body temperature to poorly crystalline hydroxyapatite (PCHA). Osteoconductive. Supplied as sterile powder and hydration solution kits.

Indications for Use

Indicated for patients requiring bone void filling in the skeletal system (extremities, posterolateral spine, pelvis) for defects not intrinsic to bony stability, including surgically created or traumatic osseous defects.

Regulatory Classification

Identification

A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.

Predicate Devices

Submission Summary (Full Text)

{0}------------------------------------------------ K101557 # 5. 510(k) Summary �) ינ JUL -1 2010 #### 510(k) Summary - Beta-bsm 5.1 Submitter: ETEX Corporation 38 Sidney Street Cambridge, MA 02139 Registration No .: 1225112 Owner/Operator No .: 9014709 Contact Person: Christopher Klaczyk Regulatory Affairs Manager Office: (617) 577-7270 x160 Mobile: (617) 710-8091 Fax: (617) 577-7170 E-Mail: cklaczyk@etexcorp.com Date Prepared: June 28, 2010 Product Code(s): MQV (21 CFR 888.3045) Classification Name: Resorbable Calcium Salt Bone Void Filler Device (21 CFR 888.3045) Device Class: II (21 CFR 888.3045) Classification Panel: Orthopaedics FDA Panel Number: 87 Proprietary Name: Beta-bsm Injectable Bone Substitute Material Predicate Device(s): Beta-bsm Injectable Bone Substitute Material (cleared as OssiFuse Bone Substitute Material, K072355) α-ΒSM (Κ072636) Device Description: Beta-bsm Injectable Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of mixing solution and mixed to form a paste. Mixing is facilitated by a syringe-to-syringe mixing system. The resulting paste can be administered to the treatment site by injection or manual application. The material can be shaped into a desired form in-situ prior to implantation. After the paste is applied to the treatment site, it hardens at body temperature and converts to an Page 5-1 {1}------------------------------------------------ apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order with a similar chemical and crystalline structure to that of natural bone minerals. Beta-bsm Injectable Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time. - Beta-bsm Injectable Bone Substitute Material is an Intended Use: implantable bone graft that is a synthetic calcium phosphate, poorly crystalline hydroxyapatite material intended for use in filling bone voids or defects of the skeletal system (i.e. the extremities, posterolateral spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Beta-bsm Injectable Bone Substitute Material is a bone graft substitute that resorbs and is replaced with new bone during the healing process. ## Materials: Synthetic calcium phosphate - Performance Data: Regression testing consistent with Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA Staff (dated June 2, 2003) has been submitted to show that the proposed changes to the predicate devices do not affect the risk profile of the devices. ਾ ਸ ごく {2}------------------------------------------------ #### 5.2 510(k) Summary - Gamma-bsm S | Submitter: | ETEX Corporation<br>38 Sidney Street<br>Cambridge, MA 02139<br>Registration No.: 1225112<br>Owner/Operator No.: 9014709 | |------------|-------------------------------------------------------------------------------------------------------------------------| |------------|-------------------------------------------------------------------------------------------------------------------------| Contact Person: Christopher Klaczyk Regulatory Affairs Manager Office: (617) 577-7270 x160 Mobile: (617) 710-8091 (617) 577-7170 Fax: E-Mail: cklaczyk(@etexcorp.com Date Prepared: June 28, 2010 Product Code(s): MQV (21 CFR 888.3045) Classification Name: Resorbable Calcium Salt Bone Void Filler Device (21 CFR 888.3045) Device Class: II (21 CFR 888.3045) Classification Panel: Orthopaedics FDA Panel Number: 87 Proprietary Name: Gamma-bsm Moldable Bone Substitute Material - Predicate Device(s): Gamma-bsm Moldable Bone Substitute Material (cleared as CaP3 Bone Void Filler, K033138) α-ΒSM (Κ072636) - Device Description: Gamma-bsm Moldable Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of mixing solution and mixed to form a putty. The resulting putty is administered to the treatment site by manual application. The material can be shaped into a desired form in-situ prior to implantation. After the putty is applied to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate end product, poorly crystalline material. The hydroxyapatite (PCHA), is of low crystalline order with a similar chemical and crystalline structure to that of natural {3}------------------------------------------------ bone minerals. Gamma-bsm Moldable Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time. - Intended Use: Gamma-bsm Moldable Bone Substitute Material is an implantable bone graft that is a synthetic calcium phosphate, poorly crystalline hydroxyapatite material intended for use in filling bone voids or defects of the skeletal system (i.e. the extremities, posterolateral spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Gamma-bsm Moldable Bone Substitute Material is a bone graft substitute that resorbs and is replaced with new bone during the healing process. - Synthetic calcium phosphate Materials: - Performance Data: Regression testing consistent with Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA Staff (dated June 2, 2003) has been submitted to show that the proposed changes to the predicate devices do not affect the risk profile of the devices. - {4}------------------------------------------------ ### 510(k) Summary - CarriGen 5.3 | Submitter: | ETEX Corporation<br>38 Sidney Street<br>Cambridge, MA 02139 | |---------------------|-------------------------------------------------------------| | Registration No.: | 1225112 | | Owner/Operator No.: | 9014709 | Contact Person: Christopher Klaczyk Regulatory Affairs Manager Office: (617) 577-7270 x160 Mobile: (617) 710-8091 Fax: (617) 577-7170 E-Mail: cklaczyk@etexcorp.com Date Prepared: June 28, 2010 Product Code(s): MQV (21 CFR 888.3045) - Classification Name: Resorbable Calcium Salt Bone Void Filler Device (21 CFR 888.3045) Device Class: II (21 CFR 888.3045) Classification Panel: Orthopaedics FDA Panel Number: 87 Proprietary Name: CarriGen Porous Bone Substitute Material Predicate Device(s): CarriGen Porous Bone Substitute Material (K093447) - Device Description: CarriGen Porous Bone Substitute Material is a synthetic, biocompatible bone graft substitute material. At the time of use, the powder component is combined with a specified volume of mixing solution and mixed to form a putty. The resulting putty is administered to the treatment site by manual application. The material can be shaped into a desired form in-situ prior to implantation. After the putty is applied to the treatment site, it hardens at body temperature and converts to an apatitic calcium phosphate material. The end product, poorly crystalline hydroxyapatite (PCHA), is of low crystalline order with a similar chemical and crystalline structure to that of natural bone minerals. CarriGen Porous Carrier Bone Substitute Material is an osteoconductive material that is resorbed and replaced by {5}------------------------------------------------ natural bone over time. - Intended Use: CarriGen Porous Bone Substitute Material is an injectable, self setting, macro-porous, osteo-conductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e. posterolateral spine), and the pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. CarriGen is a bone graft substitute that resorbs and is replaced with new bone during the healing process. - Synthetic calcium phosphate, sodium carboxymethyl Materials: cellulose (CMC), sodium carbonate and sodium bicarbonate - Performance Data: Regression testing consistent with Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA Staff (dated June 2, 2003) has been submitted to show that the proposed changes to the predicate devices do not affect the risk profile of the devices. {6}------------------------------------------------ ### 5.4 510(k) Summary - EquivaBone | <b>Submitter:</b> | ETEX Corporation<br>38 Sidney Street<br>Cambridge, MA 02139<br>Registration No.: 1225112<br>Owner/Operator No.: 9014709 | |-------------------|-------------------------------------------------------------------------------------------------------------------------| |-------------------|-------------------------------------------------------------------------------------------------------------------------| Contact Person: Christopher Klaczyk Regulatory Affairs Manager Office: (617) 577-7270 x160 Mobile: ・(617)710-8091 Fax: (617) 577-7170 E-Mail: cklaczyk@etexcorp.com June 28, 2010 Date Prepared: MQV (21 CFR 888.3045), MBP Product Code(s): Classification Name: Resorbable Calcium Salt Bone Void Filler Device Device Class: II (21 CFR 888.3045) Classification Panel: Orthopaedics FDA Panel Number: 87 - Proprietary Name: EquivaBone Osteoinductive Bone Graft Substitute - Predicate Device(s): EquivaBone Osteoinductive Bone Graft Substitute (K090855) - Device Description: EquivaBone is a biocompatible bone graft substitute material consisting of synthetic calcium phosphate, carboxymethyl cellulose (CMC) and human demineralized bone matrix (DBM). It is supplied in a single use kit as sterile powders and hydration solution that are mixed together at the time of use in the operating room to form flowable putty which is implanted manually or can be extruded through a syringe. After implantation the product hardens at body temperature and resorbs and remodels during the healing process. Each lot of DBM contained within EquivaBone is assayed for osteoinductive potential in an athymic nude mouse model. This may or may not be predictive of EquivaBone osteoinductivity in humans. {7}------------------------------------------------ - EquivaBone is a bone graft substitute that combines Intended Use: synthetic calcium phosphate and demineralized bone. It is resorbed and replaced with new bone during the healing process. It is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e. posterolateral spine) and pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. - Materials: Synthetic calcium phosphate, sodium carboxymethyl cellulose (CMC) and demineralized bone matrix (DBM) - Performance Data: Regression testing consistent with Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA Staff (dated June 2, 2003) has been submitted to show that the proposed changes to the predicate devices do not affect the risk profile of the devices. {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle or bird in flight, composed of three curved lines that suggest feathers or wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 ETEX Corporation c/o Mr. Christopher Klaczyk Regulatory Affairs Manager 38 Sidney Street Cambridge, MA 02139 JUL -1 2010 Re: K101557 Trade/Device Name: Bet Trade/Device Name: Beta-bsm Injectable Bone Graft Substitute Material, Gamma-bsm Moldable Bone Substitute Material, CarriGen Porous Bone Substitute Material and EquivaBone Osteoinductive Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV, MBP Dated: June 3, 2010 Received: June 4, 2010 Dear Mr. Klaczyk: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must {9}------------------------------------------------ Page 2 - Mr. Klaczyk comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely vours. Sincerely yours, Mark Wilkerson Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {10}------------------------------------------------ # 4. Indications For Use ### 4.1 Indications For Use - Beta-bsm 510(k) Number (if known): K.101557 Device Name: Beta-bsm Injectable Bone Substitute Material Indications for Use: Beta-bsm Injectable Bone Substitute Material is an implantable bone graft that is a synthetic calcium phosphate, poorly crystalline hydroxyapatite material intended for use in filling bone voids or defects of the skeletal system (i.e. the extremities, posterolateral spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Beta-bsm Injectable Bone Substitute Material is a bone graft substitute that resorbs and is replaced with new bone during the healing process. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | (Division Sign-Off) | | |-----------------------------------------------------------|---------| | Division of Surgical, Orthopedic, and Restorative Devices | | | 510(k) Number | K101557 | ETEX Corporation Page 4-1 {11}------------------------------------------------ ## 4.2 Indications For Use - Gamma-bsm 510(k) Number (if known): K101557 Device Name: Gamma-bsm Moldable Bone Substitute Material Indications for Use: Gamma-bsm Moldable Bone Substitute Material is an implantable bone graft that is a synthetic calcium phosphate, poorly crystalline hydroxyapatite material intended for use in filling bone voids or defects of the skeletal system (i.e. the extremities, posterolateral spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Gamma-bsm Moldable Bone Substitute Material is a bone graft substitute that resorbs and is replaced with new bone during the healing process. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Division of Surgical, Orthopedie, and Restorative Devices 510(k) Number K101557 ETEX Corporation Page 4-2 {12}------------------------------------------------ ### 4.3 Indications For Use - CarriGen 510(k) Number (if known): K101557 Device Name: CarriGen Porous Bone Substitute Material Indications for Use: CarriGen Porous Bone Substitute Material is an injectable, self setting, macro-porous, osteo-conductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e. posterolateral spine), and the pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. CarriGen is a bone graft substitute that resorbs and is replaced with new bone during the healing process. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |--------------------------------------------------------|---------| | | | | | | | (Division Sign-Off) | | | Division of Surgical, Orthopedic, | | | and Restorative Devices | | | | | | | | | | | | 510(k) Number | K101557 | | | | | | | ETEX Corporation {13}------------------------------------------------ ## 4.4 Indications For Use - EquivaBone 510(k) Number (if known): K101557 Device Name: EquivaBone Osteoinductive Bone Graft Substitute Indications for Use: EquivaBone is a bone graft substitute that combines synthetic calcium phosphate and demineralized bone. It is resorbed and replaced with new bone during the healing process. It is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e. posterolateral spine) and pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. x Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |-----------------------------------------------------------|---------| | | | | (Division Sign-Off) | | | Division of Surgical, Orthopedic, and Restorative Devices | | | | | | 510(k) Number | K101557 | ETEX Corporation Page 4-4
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