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 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 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.

AI/ML Overview

The provided text is a 510(k) summary for several bone substitute materials: Beta-bsm Injectable Bone Substitute Material, Gamma-bsm Moldable Bone Substitute Material, CarriGen Porous Bone Substitute Material, and EquivaBone Osteoinductive Bone Graft Substitute.

For all these devices, the section "Performance Data" states: "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."

This statement indicates that the performance data submitted for these devices is regression testing against a guidance document, rather than a detailed study with specific acceptance criteria and performance metrics for the devices themselves. Regression testing, in this context, implies that the manufacturer is demonstrating that changes to existing predicate devices do not introduce new risks or affect their established safety and effectiveness, rather than proving the de novo effectiveness of the device against specific, quantitative acceptance criteria.

Therefore, the document does not contain a table of acceptance criteria and reported device performance in the typical sense of a clinical or analytical study demonstrating performance against a predefined threshold. Instead, it refers to compliance with a guidance document for Class II Special Controls.

Given this, it's not possible to populate all the requested fields as they pertain to a traditional performance study. However, some fields can be addressed based on the information provided.

Acceptance Criteria and Study Information for Beta-bsm, Gamma-bsm, CarriGen, and EquivaBone

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Criteria (from guidance for regression testing)	Reported Device Performance (from regression testing)
Safety and Effectiveness	Compliance with Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA Staff (dated June 2, 2003)	Regression testing submitted to show that proposed changes to predicate devices do not affect the risk profile of the devices.
Material Properties	(Implied: Material properties of the modified device are substantially equivalent to predicate, as per guidance)	(Implied: Demonstrated continued substantial equivalence and no adverse impact from changes)
Biocompatibility	(Implied: Biocompatibility profiles of the modified devices are acceptable as per guidance)	(Implied: Demonstrated continued substantial equivalence and no adverse impact from changes)
Sterility	(Implied: Sterilization methods are validated and maintained as per guidance)	(Implied: Demonstrated continued substantial equivalence and no adverse impact from changes)
Packaging/Shelf Life	(Implied: Packaging and shelf life integrity maintained as per guidance)	(Implied: Demonstrated continued substantial equivalence and no adverse impact from changes)

Note: The document explicitly states "Regression testing consistent with Class II Special Controls Guidance Document... has been submitted to show that the proposed changes to the predicate devices do not affect the risk profile of the devices." This means the acceptance criteria are largely based on maintaining the established safety and effectiveness profile of the predicate devices following certain changes, as outlined in the specified FDA guidance for Resorbable Calcium Salt Bone Void Filler Devices. The document does not provide specific quantitative performance metrics from a de novo study.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified in the provided text. The term "regression testing" suggests re-testing of certain parameters or components affected by changes, rather than a full-scale clinical trial with a defined sample size for efficacy determination.
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable as this was regression testing against a guidance document, not a study requiring expert-established ground truth for a diagnostic or predictive algorithm.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable for the type of testing described (regression testing for device changes against guidance).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. These are bone substitute materials, not imaging analysis or AI-assisted diagnostic devices.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. These are physical implantable medical devices.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the context of device performance in a clinical or diagnostic assessment. The "ground truth" for the regression testing would be the established acceptable performance and safety profile of the predicate devices and the requirements of the Class II Special Controls Guidance Document.

8. The sample size for the training set

Not applicable. There is no mention or indication of a training set as this is not a machine learning or AI-based device.

9. How the ground truth for the training set was established

Not applicable. There is no mention or indication of a training set.

Summary

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K101557

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

Submitter:	ETEX Corporation38 Sidney StreetCambridge, MA 02139Registration No.: 1225112Owner/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

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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 Corporation38 Sidney StreetCambridge, 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

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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.

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5.4 510(k) Summary - EquivaBone

Submitter:	ETEX Corporation38 Sidney StreetCambridge, MA 02139Registration No.: 1225112Owner/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.

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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.

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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

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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

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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:

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

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4.2 Indications For Use - Gamma-bsm

510(k) Number (if known): K101557

Device Name:

Gamma-bsm Moldable Bone Substitute Material

Indications for Use:

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

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4.3 Indications For Use - CarriGen

510(k) Number (if known): K101557

Device Name:

CarriGen Porous Bone Substitute Material

Indications for Use:

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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4.4 Indications For Use - EquivaBone

510(k) Number (if known): K101557

Device Name: EquivaBone Osteoinductive Bone Graft Substitute

Indications for Use:

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

Regulation Number and Section

§ 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.