(29 days)
Not Found
No
The device description and intended use focus on a calcium sulfate formulation for bone void filling and do not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is a bone graft substitute intended to fill bone voids and support bone fragments during healing processes, which are therapeutic functions.
No
Explanation: The device, PRO-DENSE Bone Graft Substitute, is described as a bone graft substitute and void filler used in surgical procedures. Its function is to replace bone during healing and provide temporary support, not to diagnose medical conditions.
No
The device description clearly indicates it is a physical bone graft substitute made of calcium sulfate formulation (powder and solution) that forms an injectable paste and cures in situ. It also mentions manual surgical instruments and a mixing/delivery syringe, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a bone graft substitute used to fill bone voids and support bone fragments during surgery. It is applied directly to the skeletal system.
- Device Description: The description details a calcium sulfate formulation that forms an injectable paste for filling bone voids.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information about a physiological state, disease, or condition. IVDs are typically used in a laboratory or clinical setting to analyze biological specimens.
The device is a surgical implant/material used to aid in bone healing, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
MQV, FMF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extremities and pelvis
Indicated Patient Age Range
adults and pediatric patients ≥ 6 years old
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 -
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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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.
1023 Cherry Road
Memphis, TN 38117 |
|-----------------|--------------------------------------------------------------------------|
| Date: | September 21, 2018 |
| Contact Person: | Alayne Melancon |
| | Regulatory Affairs Specialist II |
| | Office: (901)290-5986 |
| | Fax: (901)867-4190 |
(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
(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.
4
(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.