(266 days)
No
The summary describes a personalized, 3D-printed implant for bone defects. While it mentions "surgical planning, personalization, and manufacturing of a patient specific device," there is no mention of AI or ML being used in this process. The performance studies focus on biomechanical testing and animal models, not on the validation of an AI/ML algorithm.
Yes
The device is an implant designed to optimize support of bone graft in large, segmental defects of the humerus, femur, and tibia, directly contributing to the treatment and healing of bone injuries.
No
The device is an implant designed to maintain the position of bone grafts in nonarticular regions of long bones, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "3D-printed personalized resorbable implant," which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the DePuy Synthes TruMatch Graft Cage – Long Bone is an implant designed to support bone graft within bone voids or surgical resections in long bones (humerus, femur, tibia). It is a physical device implanted into the body.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information about a patient's condition. Its purpose is structural support and facilitating bone healing.
Therefore, the DePuy Synthes TruMatch Graft Cage – Long Bone is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DePuy Synthes TruMatch Graft Cage – Long Bone implant is indicated for use in skeletally mature adults and adolescents (12-21)* for maintaining the relative position of bone graft substitutes within bone voids or surgical resections in the nonarticular regions of the humerus, femur, or tibia. The implant must be used in conjunction with traditional, rigid fixation.
*The TruMatch Graft Cage - Long Bone implant is indicated for use in skeletally immature adolescents, only if the device is not used across open physes.
The TruMatch Graft Cage - Long Bone implant is for patients only when the treating physician deems there is appropriate time to conduct surgical planning, personalization, and manufacturing of a patient specific device. When considering the use of the TruMatch Graft Cage - Long Bone, please ensure that you request information on the amount of time needed to manufacture and ship the device from your local DePuy Synthes sales representative. There is a delay between when the device is ordered and when the device can be delivered.
Bone graft/bone graft substitute support and containment
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
DePuy Synthes TruMatch Graft Cage - Long Bone, is a 3D-printed personalized resorbable implant that optimizes support of bone graft in large, segmental defects of the humerus, femur, and tibia.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humerus, femur, or tibia
Indicated Patient Age Range
skeletally mature adults and adolescents (12-21)*
*The TruMatch Graft Cage - Long Bone implant is indicated for use in skeletally immature adolescents, only if the device is not used across open physes.
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 performance of the subject device TruMatch Graft Cage – Long Bone was demonstrated to be substantially equivalent to predicate device OrthoMesh using an axial compression biomechanical test and a pre-clinical animal model. Axial compression testing demonstrated increased elastic deformation of the subject device as compared to the predicate device.
The pre-clinical testing utilized an ovine model of a large bone defect and demonstrated that the subject device was substantially equivalent to the predicate device in terms of radiographic union, torsional testing, micro CT analysis, histopathology, and histomorphometry.
Additionally, testing was provided demonstrating that the subject device met endotoxin requirements (less than 20EU/device), had EO and ETO residuals less than the required amount per ISO 10993-7, was mechanically stable throughout the shelf life period, and can be accurately personalized and manufactured to meet patient specific geometries.
Clinical data was not required to demonstrate the substantial equivalence of the subject device.
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.
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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December 21, 2018
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 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.
Synthes (USA) LLC Christopher Medberry Project Leader, Regulatory Affairs 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K180821
Trade/Device Name: TruMatch Graft Cage - Long Bone Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS Dated: November 26, 2018 Received: November 26, 2018
Dear Christopher Medberry:
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
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https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/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,
Daniel S. Ramsey -S 2018.12.21 15:27:52 -05'00'
FOR Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180821
Device Name TruMatch Graft Cage - Long Bone
Indications for Use (Describe)
The DePuy Synthes TruMatch Graft Cage – Long Bone implant is indicated for use in skeletally mature adults and adolescents (12-21)* for maintaining the relative position of bone graft substitutes within bone voids or surgical resections in the nonarticular regions of the humerus, femur, or tibia. The implant must be used in conjunction with traditional, rigid fixation.
*The TruMatch Graft Cage - Long Bone implant is indicated for use in skeletally immature adolescents, only if the device is not used across open physes.
The TruMatch Graft Cage - Long Bone implant is for patients only when the treating physician deems there is appropriate time to conduct surgical planning, personalization, and manufacturing of a patient specific device. When considering the use of the TruMatch Graft Cage - Long Bone, please ensure that you request information on the amount of time needed to manufacture and ship the device from your local DePuy Synthes sales representative. There is a delay between when the device is ordered and when the device can be delivered.
| 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)
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| 510(k) Summary | |
|---|---|
| Sponsor: | Synthes (Usa) Products, Llc |
| Primary Contact: | |
| Christopher J. Medberry, PhD, RAC | |
| Project Leader, Regulatory Affairs | |
| DePuy Synthes | |
| 1301 Goshen Parkway | |
| West Chester, PA 19380 | |
| Phone: (610) 719- 6806 | |
| cmedberr@its.jnj.com | |
| Alternate Contact: | |
| Stacey Bonnell, MBA, RAC | |
| Associate Director, Regulatory Affairs | |
| DePuy Synthes | |
| 1301 Goshen Parkway | |
| West Chester, PA 19380 | |
| Phone: mobile (484) 238-7519 | |
| sbonnell@its.jnj.com | |
| Date Prepared: | December 20th, 2018 |
| Proprietary | |
| Name: | TruMatch Graft Cage – Long Bone |
| Classification: | Classification: 888.3030 – Bone Fixation Appliances & Accessories |
| Product Code: HRS - Plate Fixation Bone | |
| Predicate | |
| Device: | OrthoMesh (K073115) |
| Reference | |
| Device: | TRS Cranial Bone Void Filler (K123633) |
| Device | |
| Description: | DePuy Synthes TruMatch Graft Cage - Long Bone, is a 3D-printed personalized resorbable implant that optimizes support of bone graft in large, segmental defects of the humerus, femur, and tibia. |
| Indications for | |
| Use: | The DePuy Synthes TruMatch Graft Cage – Long Bone implant is indicated for use in skeletally mature adults and adolescents (12-21)* for maintaining the relative position of bone grafts and/or bone graft substitutes within bone voids or surgical resections in the nonarticular regions of the humerus, femur, or tibia. The implant must be used in conjunction with traditional, rigid fixation. |
| *The TruMatch Graft Cage – Long Bone implant is indicated for use in skeletally immature adolescents, only if the device is not used across open physes. | |
| The TruMatch Graft Cage – Long Bone implant is for patients only when the treating physician deems there is appropriate time to conduct surgical planning, personalization, and manufacturing of a patient specific device. When considering the use of the TruMatch Graft Cage - Long Bone, please ensure that you request information on the amount of time needed to | |
| 510(k) Summary | |
| manufacture and ship the device from your local DePuy Synthes sales representative. There is a delay between when the device is ordered and when the device can be delivered. | |
| Intended use: | Bone graft/bone graft substitute support and containment |
| Substantial Equivalence: | The subject device, TruMatch Graft Cage – Long Bone, has substantially equivalent indications, technological characteristics, materials, and performance as compared to the predicate and reference devices. The present submission compared the subject device to the primary predicate, OrthoMesh (K073115), and reference device, TRS Cranial Bone Void Filler (K123633). |
| Summary Comparison of Indications | |
| The subject device has highly similar indications to a subset of that of the predicate device, wherein both devices are intended to provide support and containment to bone graft/ bone graft substitute and can only be used in combination with a rigid fixation device. The predicate device also has indications to be used without a rigid fixation device in certain anatomic locations, which are not indicated for the subject device. | |
| The comparison of indications supports substantial equivalence. | |
| Summary Comparison of Technological Characteristics | |
| The subject device, TruMatch Graft Cage – Long Bone, and predicate device, OrthoMesh, are both intended to provide support and containment to bone graft/ bone graft substitute. The devices have highly similar technological characteristics, with differences that do not affect the ability of the devices to perform their intended use. Both devices are composed of resorbable polymers with resorption rates that enable support and containment to be provided over the course of bone healing. The subject device is composed of 96% polycaprolactone/ 4% hydroxyapatite and has an approximate degradation rate of 2-4 years as supported by literature, while the predicate device is composed of 85:15 poly (L-lactide-co-glycolide) and has a degradation rate of approximately 1 year. The degradation rate of the subject device is comparable to that of the reference device (TRS Cranial Bone Void Filler) as they are composed of the same material, same coating, manufactured using the same additive manufacturing methods, and sterilized using ethylene oxide. | |
| Both the subject and predicate devices are designed to be patient matching. While the subject device is manufactured to fit a patient specific geometry, the predicate device is shaped to match a patient's bone within the operating room. Though the geometrical structure of the devices differ, both the subject and predicate devices have an outer structure to provide support laterally. The subject device also provides support bone graft/bone graft substitute with an inner structure. | |
| 510(k) Summary | |
| The comparison of technological characteristics supports substantial equivalence. | |
| Summary Comparison of Performance Testing | |
| The performance of the subject device TruMatch Graft Cage – Long Bone was demonstrated to be substantially equivalent to predicate device OrthoMesh using an axial compression biomechanical test and a pre-clinical animal model. Axial compression testing demonstrated increased elastic deformation of the subject device as compared to the predicate device. | |
| The pre-clinical testing utilized an ovine model of a large bone defect and demonstrated that the subject device was substantially equivalent to the predicate device in terms of radiographic union, torsional testing, $\mu$ CT analysis, histopathology, and histomorphometry. | |
| Additionally, testing was provided demonstrating that the subject device met endotoxin requirements (less than 20EU/device), had EO and ETO residuals less than the required amount per ISO 10993-7, was mechanically stable throughout the shelf life period, and can be accurately personalized and manufactured to meet patient specific geometries. | |
| The performance testing supports substantial equivalence. | |
| Clinical data | |
| Clinical data was not required to demonstrate the substantial equivalence of the subject device. | |
| Conclusions | |
| The conclusions drawn from the comparison of indications, technological characteristics, and performance testing demonstrate substantial equivalence of subject device TruMatch Graft Cage – Long Bone to the legally marketed predicate OrthoMesh (K073115) |
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