PRODENSE Bone Graft Substitute

K182823 · Wrightmedicaltechnologyinc · MQV · Nov 2, 2018 · Orthopedic

Device Facts

• Record ID: K182823
• Device Name: PRODENSE Bone Graft Substitute
• Applicant: Wrightmedicaltechnologyinc
• Product Code: MQV · Orthopedic
• Decision Date: Nov 2, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3045
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

PRO-DENSE resultant paste is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities and pelvis) to cure in situ. These open bone voids may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process. The PRO-DENSE paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process. PRO-DENSE is provided sterile for single use only. For the PRO-DENSE™ Core Decompression Procedure Kit: The PRO-DENSE™ Core Decompression Procedure Kit, consisting of a bone void filler and manual surgical instruments, is intended to be used during core decompression procedures. The bone void filler component resorbs and is replaced with bone during the healing process. The bone void filler included in the PRO-DENSE™ Core Decompression Procedure Kit is not intended to be used as a load-bearing device. For the Mixing and Delivery system: The Mixing and Delivery syringe is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.

Device Story

PRO-DENSE is a calcium sulfate-based bone graft substitute; consists of powder and aqueous mixing solution. Components mixed to form injectable paste; injected or digitally packed into non-load-bearing bone voids/gaps. Paste cures in situ via hydration reactions; resorbs and is replaced by bone during healing. Used in orthopedic surgical settings; operated by surgeons. Can augment provisional hardware (e.g., K-wires) for temporary support of bone fragments. Kit includes manual surgical instruments for core decompression. Mixing and delivery syringe facilitates graft placement. Benefits include filling bone voids and supporting healing process without providing permanent structural support.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical bench testing, including injection testing, procedural evaluations, biocompatibility assessment per ISO 10993, and pyrogenicity testing.

Technological Characteristics

Calcium sulfate-based bone graft substitute. Consists of powder and aqueous mixing solution. Cures via hydration reaction. Provided sterile for single use. Includes manual surgical instruments for access and debridement. Non-load-bearing.

Indications for Use

Indicated for adults and pediatric patients ≥ 6 years old with open bone voids/gaps in the extremities and pelvis resulting from benign bone cysts, tumors, surgical osseous defects, or traumatic injury. Also indicated for use in core decompression procedures and as a delivery system for bone graft materials. Not for use in load-bearing applications or where structural support is required.

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

• PRO-DENSE Bone Graft Subsitute (K181255)

Submission Summary (Full Text)

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November 2, 2018

Wright Medical Technology, Inc. Alayne Melancon Regulatory Affairs Specialist II 1023 Cherry Road Memphis, Tennessee 38117

Re: K182823

Trade/Device Name: PRODENSE™ Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV, FMF Dated: September 21, 2018 Received: October 4, 2018

Dear Ms. Melancon:

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

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

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For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

# Indications for Use

510(k) Number (if known)

K182823

Device Name PRODENSE™ Bone Graft Substitute

#### Indications for Use (Describe)

PRO-DENSE resultant paste is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities and pelvis) to cure in situ. These open bone voids may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), surgically created osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.

The PRO-DENSE paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.

PRO-DENSE is provided sterile for single use only.

For the PRO-DENSE™ Core Decompression Procedure Kit:

The PRO-DENSE™ Core Decompression Procedure Kit, consisting of a bone void filler and manual surgical instruments, is intended to be used during core decompression procedures. The bone void filler component resorbs and is replaced with bone during the healing process. The bone void filler included in the PRO-DENSE™ Core Decompression Procedure Kit is not intended to be used as a load-bearing device.

For the Mixing and Delivery system:

The Mixing and Delivery syringe is intended to be used for the delivery of hydrated allograft, or synthetic bone graft material to an orthopedic surgical site.

Type of Use (Select one or both, as applicable)

X 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:

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Image /page/3/Picture/0 description: The image shows the logo for Wright. The logo consists of two overlapping trapezoids, one red and one orange, on the left side of the word "WRIGHT" in red font. Below the word "WRIGHT" is the phrase "FOCUSED EXCELLENCE" in a smaller, gray font.

1023 Cherry Road Memphis, TN 38117 wright.com

#### 510(k) SUMMARY

In accordance with the Food and Drug Administration rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the PRO-DENSE Bone Graft Substitute.

#### (a)(1) MANUFACTURER IDENTIFICATION

| Submitted By: | Wright Medical Technology, Inc.<br>1023 Cherry Road<br>Memphis, TN 38117 |
|-----------------|--------------------------------------------------------------------------|
| Date: | September 21, 2018 |
| Contact Person: | Alayne Melancon |
| | Regulatory Affairs Specialist II |
| | Office: [phone] |
| | Fax: [phone] |

# (a)(2) SUBJECT DEVICE INFORMATION

| Proprietary Name: | PRO-DENSE™ Bone Graft Substitute |
|----------------------------------|----------------------------------|
| Common Name: | Bone Void Filler |
| Classification Name & Reference: | 21 CFR 888.3045 - Class II |
| Device Product Code & Panel: | MQV – Orthopedic |

#### (a)(3) PREDICATE DEVICE INFORMATION

PRO-DENSE Bone Graft Subsitute

K181255

#### (a)(4) DEVICE DESCRIPTON

PRO-DENSE Bone Graft Substitute is a calcium sulfate formulation consisting of a powder component and an aqueous mixing solution. When the two components are mixed according to directions, an injectable paste is formed. This paste is subsequently injected and/or digitally packed into a bone void where the graft cures and hardens via hydration reactions.

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#### (a)(5) INTENDED USE

PRO-DENSE resultant paste is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities and pelvis) to cure in situ. These open bone voids may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.

The PRO-DENSE paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.

PRO-DENSE is provided sterile for single use only.

For the PRO-DENSE™ Core Decompression Procedure Kit:

The PRO-DENSE™ Core Decompression Procedure Kit, consisting of a bone void filler and manual surgical instruments, is intended to be used during core decompression procedures. The bone void filler component resorbs and is replaced with bone during the healing process. The bone void filler included in the PRO-DENSE™ Core Decompression Procedure Kit is not intended to be used as a load-bearing device.

For the Mixing and Delivery system:

The Mixing and Delivery syringe is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.

### (a)(6) TECHNOLOGICAL CHARACTERISTICS COMPARISON

The subject implant is identical to that of the predicate. The subject device includes the use of PRO-DENSE Bone Graft Substitute with manual surgical accessory instruments for the access and debridement of benign bone cysts and tumors, surgically created osseous defects, and osseous defects created from traumatic injury to the bone.

# (b)(1) SUBSTANTIAL EQUIVALENCE - NON-CLINICAL EVIDENCE

The following evaluations were conducted to support the substantial equivalence of the PRO-DENSE Bone Graft Substitute:

- -Injection Testing and Procedural Evaluations for Instrumentation
- -Biocompatibility Assessment per ISO 10993
- Pyrogenicity Testing -

# (b)(2) SUBSTANTIAL EQUIVALENCE - CLINICAL EVIDENCE N/A

### (b)(3) SUBSTANTIAL EQUIVALENCE - CONCLUSIONS

The design characteristics of the subject device do not raise any new types of questions of safety or effectiveness. The subject devices can be expected to perform at least as well as the predicate systems and are substantially equivalent.