Who is the manufacturer of Mineral Collagen Composite Bioactive Moldable?

Collagen Matrix, Inc. filed the 510(k) submission for Mineral Collagen Composite Bioactive Moldable (K221735).

What is the FDA product code for Mineral Collagen Composite Bioactive Moldable?

MQV. It is classified under 21 CFR 888.3045 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for Mineral Collagen Composite Bioactive Moldable?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Mineral Collagen Composite Bioactive Moldable?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Mineral Collagen Composite Bioactive Moldable

Q: What are the predicate devices for Mineral Collagen Composite Bioactive Moldable?

Mineral Collagen Composite Bioactive Moldable (K182074).

K221735 · Collagen Matrix, Inc. · MQV · Dec 20, 2022 · Orthopedic

Device Facts

Record ID	K221735
Device Name	Mineral Collagen Composite Bioactive Moldable
Applicant	Collagen Matrix, Inc.
Product Code	MQV · Orthopedic
Decision Date	Dec 20, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3045
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Mineral Collagen Composite Bioactive Moldable is intended for use as a bone void filler for voids or gaps, that are not intrinsic to the stability of the bony structure. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process. For spine applications, Mineral Collagen Composite Bioactive Moldable is combined with either autogenous bone marrow or autograft with saline and can also be used with autograft as a bone graft extender.

Device Story

Mineral Collagen Composite Bioactive Moldable is an osteoconductive, bioactive, porous bone graft matrix; composed of anorganic bovine bone mineral, 45S5 bioactive glass, and type I bovine collagen. Device is provided sterile and moldable upon hydration. Intended for surgical use by physicians to fill non-structural bony voids or gaps in extremities, pelvis, and posterolateral spine. Implant is packed into defect site; resorbs over time and is replaced by host bone during healing. In spine applications, used with autogenous bone marrow or autograft. Provides a scaffold for bony ingrowth.

Clinical Evidence

No clinical data. Bench testing not required due to identical technological characteristics to predicate. Animal study (rabbit femoral condyle critical-sized defect model) compared subject device to reference device (SIGNAFUSE), demonstrating equivalent performance for expanded indications.

Technological Characteristics

Composition: Anorganic bone mineral (ASTM F1581), 45S5 bioactive glass (ASTM F1538), and type I bovine collagen. Form: Strip or cylindrical matrix, moldable upon hydration. Sterilization: Gamma irradiation (ISO 11137), SAL 10^-6. Biocompatibility: ISO 10993 compliant. Non-pyrogenic. Single-use.

Indications for Use

Indicated for patients requiring bone void filling in the extremities, pelvis, and posterolateral spine for defects not intrinsic to bony stability. Defects may be surgically created or traumatic. For spine, used with autogenous bone marrow or autograft with saline, or as a bone graft extender with autograft.

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

Mineral Collagen Composite Bioactive Moldable (K182074)

Reference Devices

SIGNAFUSE PUTTY Bioactive Bone Graft (K132071)

Related Devices

K182074 — Mineral Collagen Composite Bioactive Moldable · Collagen Matrix, Inc. · Mar 21, 2019
K231942 — Mineral Collagen Composite Bioactive Extra Moldable · Collagen Matrix, Inc. · Aug 2, 2023
K171284 — FIBERGRAFT BG Matrix Bone Graft Substitute · Prosidyan, Inc. · Jun 30, 2017
K240424 — Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix · Collagen Matrix, Inc. · Mar 12, 2024
K182670 — FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute · Prosidyan, Inc. · Dec 20, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ December 20, 2022 Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Collagen Matrix, Inc. Peggy Hansen SVP, Regulatory and Clinical Affairs 15 Thornton Road Oakland. New Jersey 07436 Re: K221735 Trade/Device Name: Mineral Collagen Composite Bioactive Moldable Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: November 21, 2022 Received: November 22, 2022 Dear Peggy Hansen: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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 of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Laura C. Rose -S Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K221375 #### Device Name Mineral Collagen Composite Bioactive Moldable #### Indications for Use (Describe) Mineral Collagen Composite Bioactive Moldable is intended for use as a bone void filler for voids or gaps, that are not intrinsic to the stability of the bony structure. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process. For spine application Mineral Collagen Composite Bioactive Moldable is combined with either autogenous bone marrow or autograft with saline and can also be used with autograft as a bone graft extender. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| |× Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. {3}------------------------------------------------ ### 510(k) SUMMARY | 1. | Applicant Information | | | | |----|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|--|--| | | Applicant Name: Address: Telephone: Fax: | Collagen Matrix, Inc. 15 Thornton Road Oakland, New Jersey 07436 (201) 405-1477 (201) 405-1355 | | | | | Contact Person: | Peggy Hansen Sr. Vice President, Regulatory and Clinical Affairs phansen@collagenmatrix.com | | | | | Date Prepared: | July 18, 2022 | | | | 2. | Name of the Device | | | | | | Device Trade Name: | Mineral Collagen Composite Bioactive Moldable | | | | | Device Common Name(s): | Bone Void Filler Bone Graft Matrix Bone Graft Substitute | | | | | Device Classification Name: | Filler, Bone Void, Calcium Compound 888.3045 MQV Class II | | | | 3. | Legally Marketed Devices to Which Substantial Equivalence is Claimed | | | | | | Primary Predicate Device: | Mineral Collagen Composite Bioactive Moldable Collagen Matrix, Inc. K182074 | | | | | Reference Device: | SIGNAFUSE PUTTY Bioactive Bone Graft Bioventus, Inc. K132071 | | | # 4. Description of the Device Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix is composed of anorganic bone mineral, bioactive glass, and type I collagen that can be molded to fit the bone defect. It is an osteoconductive, bioactive, porous implant that allows for bony ingrowth across the graft site. The bone graft matrix is slowly resorbed and replaced by new bone tissue during the natural healing process. The anorganic bone mineral component of the bone graft matrix is a natural, porous bone graft material produced by removal of all organic components from bovine bone. The composition of the anorganic bone mineral meets ASTM F1581 standard specifications for composition of {4}------------------------------------------------ anorganic bone for surgical implants. The bioactive glass component of the device is made of 45S5 Bioactive Glass and meets ASTM F1538 standard specifications for glass and glass ceramics biomaterials for implantation. The purified type I collagen is derived from bovine Achilles tendon. The product is available in various sizes and is provided sterile, non-pvrogenic, and for single use only. # 5. Intended Use Mineral Collagen Composite Bioactive Moldable is intended for use as a bone void filler for voids or qaps, that are not intrinsic to the stability of the bony structure. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process. For spine applications, Mineral Collagen Composite Bioactive Moldable is combined with either autogenous bone marrow or autograft with saline and can also be used with autograft as a bone graft extender. # 6. Summary/Comparison of Technical Characteristics This submission expands the indications for use of Mineral Collagen Composite Bioactive Moldable for use in the extremities and pelvis. The subject device has equivalent technological characteristics as the cited legally marketed predicate Mineral Collagen Composite Bioactive Moldable (K182074) device. | Feature | Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix (This submission) | Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix (K182074) | Bioactive Bone Graft Putty SIGNAFUSE PUTTY Reference Device (K132071) | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | Mineral Collagen Composite Bioactive Moldable is intended for use as a bone void filler for voids or gaps, that are not intrinsic to the stability of the bony structure. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process. For spine applications, Mineral Collagen Composite Bioactive Moldable is combined with either autogenous bone marrow or autograft with saline and can | Mineral Collagen Composite Bioactive Moldable combined with either autogenous bone marrow or autograft with saline is indicated for bony voids or gaps, that are not intrinsic to the stability of the bony structure; Mineral Collagen Composite Bioactive Moldable can also be used with autograft as a bone graft extender. The device is to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process. | Bioactive Bone Graft Putty is a bone void filler device intended for use in bony voids or gaps 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. Bioactive Bone Graft Putty is indicated to be packed gently into bony voids or gaps of the skeletal system (i.e., extremities, pelvis and posterolateral spine fusion procedures). Bioactive Bone Graft Putty can also be used with autograft as a bone graft extender in the posterolateral spine. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process. | {5}------------------------------------------------ | Feature | Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix (This submission) | Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix (K182074) | Bioactive Bone Graft Putty SIGNAFUSE PUTTY Reference Device (K132071) | |-------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------| | | also be used with autograft as a bone graft extender. | | | | Physical Form | Strip or Cylindrical matrix (moldable upon hydration) | Strip or Cylindrical matrix (moldable upon hydration) | Putty preloaded into a syringe applicator or Strip (moldable) | | Color | White to off-white | White to off-white | White to off-white | | Material Composition | • Calcium phosphate (anorganic bone mineral) • Bioactive glass • Type I bovine collagen | • Calcium phosphate (anorganic bone mineral) • Bioactive glass • Type I bovine collagen | • Calcium phosphate (60%HA:40%TCP) • Bioactive glass • Alkylene oxide polymer | | Product Sizes | 2.5 cc – 40 cc | 2.5 cc – 40 cc | 2.5 cc – 10 cc | | Biocompatibility | Biocompatible ISO 10993 | Biocompatible ISO 10993 | Biocompatible ISO 10993 | | Sterility | Sterile, SAL 10-6 | Sterile, SAL 10-6 | Sterile, SAL 10-6 | | | Gamma irradiation, ISO11137 | Gamma irradiation, ISO11137 | Gamma irradiation, ISO11137 | | Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Non-pyrogenic | | Single Use/ Reuse | Single use only | Single use only | Single use only | # 7. Performance Data In vivo and in vitro testing of the subject device was conducted to demonstrate substantial equivalence of the subject device to its predicate devices. The following performance data are provided in support of the substantial equivalence determination. # Biocompatibility Testing Additional biocompatibility data was not required to determine substantial equivalence. There are no changes to the product and the performance data remains the same as that submitted for the original submission (K182074). # Sterilization, Pyrogen, Endotoxin, Packaging and Shelf Life Testing Sterilization validation, pyrogen testing, packaging validation and shelf life testing were completed under the original submission. K182074, and there have been no changes to the product since the original submission. Each lot of finished devices is tested for bacterial endotoxin for lot release. # Bench Testing Bench testing was not required to determine substantial equivalence. The technological characteristics remains the same as that submitted for the original submission. # Animal Testing The performance of the device in a rabbit femoral condyle critical-sized defect model was compared to the performance of the reference device, SIGNAFUSE bioactive bone graft. The results demonstrate performance substantially equivalent to the reference device with regards to the expansion of the indications for use. # Clinical Studies Clinical performance data was not required to determine substantial equivalence. {6}------------------------------------------------ # 8. Conclusions Drawn from Non-clinical Studies The conclusions drawn from the nonclinical tests demonstrate that the device is substantially equivalent to its predicate and reference devices.