Who is the manufacturer of DSM Biomedical Calcium Phosphate Cement?

Dsm Biomedical filed the 510(k) submission for DSM Biomedical Calcium Phosphate Cement (K230054).

What is the FDA product code for DSM Biomedical Calcium Phosphate Cement?

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

What is the regulatory pathway for DSM Biomedical Calcium Phosphate Cement?

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

Who can help prepare an FDA 510(k) submission like DSM Biomedical Calcium Phosphate Cement?

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.

DSM Biomedical Calcium Phosphate Cement

Q: What are the predicate devices for DSM Biomedical Calcium Phosphate Cement?

DSM Biomedical Calcium Phosphate Cement (K173362).

K230054 · Dsm Biomedical · MQV · Mar 21, 2023 · Orthopedic

Device Facts

Record ID	K230054
Device Name	DSM Biomedical Calcium Phosphate Cement
Applicant	Dsm Biomedical
Product Code	MQV · Orthopedic
Decision Date	Mar 21, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3045
Device Class	Class 2

Intended Use

DSM Biomedical Calcium Phosphate Cement is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created from traumatic injury to the bone. The Calcium Phosphate Cement is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The Calcium Phosphate Cement cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support media and is not intended to provide structural support during the healing process. The Calcium Phosphate Cement resorbs and is replaced by bone during the healing process.

Device Story

Injectable, sculptable, drillable bone void filler; composed of calcium phosphate and bovine collagen powder. Supplied in female luer syringe; mixed with saline via syringe-to-syringe transfer. Used by surgeons in clinical settings to fill non-structural bony voids or gaps in extremities and pelvis; augments provisional hardware (K-wires, plates, screws) for temporary support of bone fragments. Cures in situ; resorbs and is replaced by bone during healing. Benefits include temporary support during surgical procedures and facilitation of bone regeneration.

Clinical Evidence

No clinical data. Bench testing included material characterization, handling, injectability, setting time, compressive strength, X-ray diffraction, porosity, and anchor pull-out strength. Biocompatibility testing per ISO 10993-1 (cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity). Performance animal testing: ovine critical-sized femoral defect model compared DSM+saline to Stryker Hydroset; 12-week results showed comparable new bone formation (5.8% vs 6.3%) and material resorption (84.2% vs 86.6% remaining).

Technological Characteristics

Calcium phosphate powder with bovine collagen; converts to hydroxyapatite in vivo. Injectable, sculptable, drillable form. Gamma sterilized; single-use. Complies with ASTM F1185 for hydroxylapatite. Packaging meets ISO 11607-1. Bovine collagen sourced per ISO 22442-2.

Indications for Use

Indicated for patients requiring filling of bony voids or gaps in the skeletal system (extremities and pelvis) resulting from surgical creation or traumatic injury. Contraindicated for voids intrinsic to the stability of the bony structure.

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

DSM Biomedical Calcium Phosphate Cement (K173362)

Reference Devices

Stryker Hydroset

Related Devices

K173362 — DSM Biomedical Calcium Phosphate Cement · Kensey Nash Corporation Dba Dsm Biomedical · Apr 3, 2018
K173572 — DSM Biomedical Calcium Phosphate Cement with Microspheres · Kensey Nash Corporation Dba Dsm Biomedical · May 9, 2018
K141746 — AS20 COMPOSITE GRAFT · Wrightmedicaltechnologyinc · Aug 4, 2014
K243526 — MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty · Orthocon, Inc. · Dec 5, 2024
K082498 — GRAFTYS HBS · Graftys · Feb 25, 2009

Submission Summary (Full Text)

{0}------------------------------------------------ March 21, 2023 Image /page/0/Picture/1 description: The image shows the logo of 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. DSM Biomedical Diana Osgood Senior Regulatory Affairs Specialist 735 Pennsylvania Drive Exton, Pennsylvania 19431 Re: K230054 Trade/Device Name: DSM Biomedical Calcium Phosphate Cement Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV, OIS, Dated: January 6, 2023 Received: January 6, 2023 Dear Ms. Diana Osgood: 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 mediation-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. # Sara S. Thompson -S For Laurence D. Coyne. Ph.D. 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) K230054 Device Name DSM Biomedical Calcium Phosphate Cement #### Indications for Use (Describe) DSM Biomedical Calcium Phosphate Cement is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created from traumatic injury to the bone. The Calcium Phosphate Cement is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The Calcium Phosphate Cement cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support media and is not intended to provide structural support during the healing process. The Calcium Phosphate Cement resorbs and is replaced by bone during the healing process. | 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}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for DSM, a global science-based company active in health, nutrition, and materials. The logo consists of a colorful abstract graphic on the left and the letters "DSM" in a bold, blue font on the right. The graphic is composed of overlapping, curved shapes in various colors, including blue, green, yellow, and purple, creating a sense of dynamism and innovation. ### 510(k) Summary # I. SUBMITTER | Submitter: | DSM Biomedical 735 Pennsylvania Drive Exton, PA 19341 | |-----------------|-------------------------------------------------------------| | Phone: | 484-713-2100 | | Contact Person: | Diana Osgood | | Date Prepared: | March 14, 2023 | # II. DEVICE | Trade Name: | DSM Biomedical Calcium Phosphate Cement | |----------------------|----------------------------------------------------------------------------------------------------------------------| | Common/Usual Name: | Bone Void Filler | | Classification Name: | Resorbable Calcium Salt Bone Void Filler Device | | Classification | 21 CFR 880.3045 | | Regulation: | | | Device Class: | 2 | | Device Code: | MQV: Filler, Bone Void, Calcium Compound OIS: Calcium Salt Bone Void Filler, Drillable, Non-screw Augmentation | | Advisory Panel: | Orthopedic | # III. PREDICATE DEVICE Substantial equivalence is claimed to the following device: - . DSM Biomedical Calcium Phosphate Cement, K173362 # IV. DEVICE DESCRIPTION {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for DSM, a global science-based company. The logo consists of a colorful abstract graphic on the left and the letters "DSM" in bold blue font on the right. The graphic is composed of overlapping shapes in various colors, including blue, green, orange, and purple, creating a sense of dynamism and innovation. The overall design is modern and corporate, reflecting the company's focus on science and technology. The DSM Calcium Phosphate Cement is a line extension to the current DSM Calcium Phosphate Cement product line, which introduces the 1cc size and a new packaging configuration. DSM Calcium Phosphate Cement is an injectable, sculptable, drillable, fast self-setting bone substitute. DSM Calcium Phosphate Cement is composed of calcium phosphate, which converts to hydroxyapatite in vivo, and bovine collagen powder. The device can also be used to augment provisional hardware to help support bone fragments during the surgical procedure. The cement is provided in a powder form and is packaged in a female luer syringe. An empty male luer syringe is provided to allow for syringeto-syringe mixing of the powder with saline at the required powder-to-liquid ratio. DSM Calcium Phosphate Cement is supplied sterile by gamma irradiation and is non-pyrogenic. #### V. INDICATIONS FOR USE: DSM Biomedical Calcium Phosphate Cement is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created, or osseous defects created from traumatic injury to the bone. The Calcium Phosphate Cement is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The Calcium Phosphate Cement cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support media and is not intended to provide structural support during the healing process. The Calcium Phosphate Cement resorbs and is replaced by bone during the healing process. #### TECHNOLOGICAL CHARACTERSTICS WITH THE VI. COMPARISON OF PREDICATE DEVICE The DSM Calcium Phosphate Cement is a line extension of the currently cleared 5cc DSM CPC (predicate device, K173362). The 1cc device maintains the same formulation and indication for use as the 5cc device but will be packaged in a different configuration. The subject device is substantially {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for DSM, a global science-based company active in health, nutrition, and materials. The logo consists of a colorful abstract graphic on the left and the letters "DSM" in bold blue font on the right. The graphic is composed of overlapping curved shapes in various colors, including blue, green, orange, and purple, forming a circular design with a hexagonal space in the center. equivalent in terms of indications for use, material composition, technological characteristics, and performance characteristics to the predicate device. The devices are compared in the table below. | Characteristic | 1cc DSM Biomedical Calcium Phosphate Cement (Subject Device) | DSM Biomedical Calcium Phosphate Cement (K173362 Predicate Device) | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | DSM Biomedical Calcium Phosphate Cement is indicated to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These defects may be surgically created, or osseous defects created from traumatic injury to the bone. The Calcium Phosphate Cement is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The Calcium Phosphate Cement cured in situ provides an open void/gap filler that can augment provisional hardware (e.g., K-Wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support media and is not intended to provide structural support during the healing process. The Calcium Phosphate Cement resorbs and is replaced by bone during the healing process. | DSM Biomedical Calcium Phosphate Cement is indicated to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These defects may be surgically created, or osseous defects created from traumatic injury to the bone. The Calcium Phosphate Cement is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The Calcium Phosphate Cement cured in situ provides an open void/gap filler that can augment provisional hardware (e.g., K-Wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support media and is not intended to provide structural support during the healing process. The Calcium Phosphate Cement resorbs and is replaced by bone during the healing process. | | Material | Calcium phosphate powder with bovine collagen mixed with saline to form hydroxyapatite | Calcium phosphate powder with bovine collagen mixed with saline, patient's blood, or patient's bone marrow aspirate to form hydroxyapatite | | Form | Injectable, sculptable, drillable, and fast setting calcium phosphate cement that converts to hydroxyapatite | Injectable, sculptable, drillable, and fast setting calcium phosphate cement that converts to hydroxyapatite | | Packaging | Powder pre-packaged in a female luer syringe, packaged with accessories to | Powder prepackaged in a mixing and delivery syringe, packaged with | | Characteristic | 1cc DSM Biomedical Calcium Phosphate Cement (Subject Device) | DSM Biomedical Calcium Phosphate Cement (K173362 Predicate Device) | | | aid in the mixing and delivery of cement | accessories to aid in the mixing and delivery of cement | | Sterilization | Sterile by gamma irradiation | Sterile by gamma irradiation | | Reusable | Single Use Device | Single Use Device | | Biocompatible | Yes | Yes | | Sizes Offered | 1cc | 5cc | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for DSM, a global science-based company active in health, nutrition, and materials. The logo consists of a colorful abstract graphic on the left and the letters "DSM" in blue on the right. The graphic is composed of overlapping curved shapes in various colors, including blue, green, yellow, and purple, arranged around a central hexagonal shape. The letters "DSM" are in a bold, sans-serif font and are positioned to the right of the graphic. The DSM Calcium Phosphate Cement is a line extension to the current DSM CPC product line, which introduces the 1cc size and a new packaging configuration. DSM Biomedical Calcium Phosphate Cement and the predicate device have identical indications for use and are for use in the same target population. The subject and predicate devices are composed of the same materials and are the delivered in the same form. Both are sterilized by gamma irradiation and are for single use only. The additional size and new packaging of the subject device does not raise questions of substantial equivalence as verification testing confirms that the subject device meets the established design requirements. # VII. SUMMARY OF NON-CLINICAL TESTING TO SUPPORT SUBSTANTIAL EQUIVALENCE The following performance data was provided in support of the substantial equivalence determination. #### Mechanical and Physical Testing Material characterization and performance testing of the DSM Biomedical Calcium Phosphate Cement was completed in accordance with the FDA Guidance Document, Resorbable Calcium Salt Bone Void Filler Device and ASTM F1185 Standard Specification for Composition of {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for DSM, a global science-based company. The logo consists of a colorful abstract graphic on the left and the letters "DSM" in bold blue font on the right. The graphic is composed of overlapping, curved shapes in shades of blue, green, yellow, and purple, creating a sense of movement and dynamism. Hydroxylapatite for Surgical Implants. Bench testing included product appearance, handling, injectability, setting time, compressive strength, X-ray diffraction, porosity, and anchor pull out strength. The Bacterial Endotoxins Test (BET) was conducted on the finished device to detect and quantify the presence of bacterial endotoxins using the gel-clot method. The device met endotoxin limit specifications according to FDA-recognized standards USP <85> Bacterial Endotoxins Test and AAMI ANSI ST72: 2019 Bacterial Endotoxins - Test methodologies, routine monitoring, and alternative to batch testing. The endotoxin limit is not more than 20 Endotoxin Units per device. The packaging of the subject device was designed to meet the requirements of ISO 11607-1. The subject device is gamma sterilized and has been validated per ISO 11137-1 and ISO 11137-2. Stability testing on the device was performed and confirms the shelf life of the subject device. # Biocompatibility Testing Biocompatibility testing was completed in accordance with the requirements of ISO 10993-1: 2018, Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing within a Risk Management Process for a permanent implant device with tissue/bone contact. Testing included the following biological effects: - Cytotoxicity per ISO 10993-5 . - Sensitization per ISO 10993-10 ● - Irritation per ISO 10993-10 . - Acute Systemic Toxicity per ISO 10993-11 ● - Genotoxicity per ISO 10993-3 . - Subacute Systemic Toxicity per ISO 10993-3 ● {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the DSM company logo. On the left side of the logo, there is a colorful abstract design with blue, green, purple, and orange colors. On the right side of the logo, the company name "DSM" is written in bold blue letters. Pyrogenicity testing per USP<85> and Rabbit Material Mediated Pyrogenicity per ISO 10993-11 have been completed to verify that the device is non-pyrogenic. The bovine collagen is sourced in accordance with ISO 22442-2 and per FDA Guidance Document, Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices). Viral inactivation studies per ISO 22442-3 and a residual chemical assessment per ISO 10993-17 were conducted. Results indicate that the device's biocompatibility profile is acceptable. #### Performance Animal Testing The performance of DSM Biomedical Calcium Phosphate Cement plus saline (DSM + Saline) was compared to Stryker Hydroset in an ovine critical sized femoral defect model. At the 12week timepoint, animal study data demonstrated new bone formation averages of 5.8% ±-2% in the DSM + saline group, 6.3% ±-3.2% in the Hydroset predicate group, and 24.3% ±-7.3% in the empty defect negative control group. Animal study data demonstrated that approximately 84.2% of implant material remained in the DSM + saline group, and 86.6% remained in the Hydroset predicate group 12 weeks following implantation. Clinical performance has not been evaluated. #### VII. CONCLUSIONS Pursuant to section 510(k), DSM Biomedical Calcium Phosphate Cement is substantially equivalent to the predicate device DSM Biomedical Calcium Phosphate Cement with regard to indication for use, technological characteristics (including principles of operation), and performance characteristics.