(27 days)
Not Found
No
The document describes bone graft substitute materials and their physical properties and intended use. There is no mention of any computational or analytical functions that would involve AI or ML.
Yes
These devices are bone graft substitutes intended to fill bone voids or defects, which directly addresses a medical condition (bone defects) and aids in the healing process by being replaced with new bone.
No
Explanation: The device is described as an implantable bone graft substitute material intended for filling bone voids or defects, and it resorbs and is replaced by new bone during healing. Its function is to facilitate bone regeneration, not to diagnose a condition.
No
The device descriptions clearly indicate that these are physical bone substitute materials supplied as powders and solutions that are mixed and implanted. There is no mention of software as the primary component or function.
Based on the provided text, these devices are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use: The intended use for all listed devices is to fill bone voids or defects in the skeletal system. This is a therapeutic application, not a diagnostic one. IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The descriptions detail the composition and physical properties of the materials, how they are prepared and implanted, and how they function within the body (resorption and replacement with new bone). This aligns with the description of an implantable medical device, not a device used for in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, these devices are classified as implantable bone graft substitutes, which are medical devices used for surgical procedures, not IVDs.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MQV, MBP
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 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.
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 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. Gamma-bsm Moldable Bone Substitute Material is an osteoconductive material that is resorbed and replaced by natural bone over time.
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 natural bone over time.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skeletal system (i.e. the extremities, posterolateral spine and pelvis)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K072355, K072636, K033138, K093447, K090855
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
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.(b)
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.
0
5. 510(k) Summary
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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
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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.
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5.2 510(k) Summary - Gamma-bsm
S
| 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 (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.
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510(k) Summary - CarriGen 5.3
| 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: 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
| 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
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
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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
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