(127 days)
DePuy Synthes VOLT™ Mini Fragment Plating System:
The VOLT™ Mini Fragment Plating System is indicated for internal fracture fixation of bones and bone fragments of the appendicular skeleton appropriate for the implant size.
The VOLT™ Mini Fragment Plating System is intended for adults and both children (2-12 years) and adolescents (12-21 years) in which growth plates (physes) have fused or in which unfused growth plates will not be compromised by fixation.
If used in the femur, tibia, humerus, patella, or pelvis the VOLT™ Mini Fragment Plating System can only be used for non-load bearing stabilization and reduction.
DePuy Synthes VOLT™ Small Fragment Plating System:
The VOLT Small Fragment Plating System is indicated for internal fracture fixation of bones and bone fragments of the appendicular skeleton appropriate for the implant size.
The VOLT Small Fragment Plating System is intended for adults and both children (2-12 years) and adolescents (12-21 years) in which growth plates (physes) have fused or in which unfused growth plates will not be compromised by fixation.
If used in the femur the VOLT Small Fragment Plating System can only be used for non-load bearing stabilization and reduction.
DePuy Synthes VOLT™ Mini Fragment Plating System
The DePuy Synthes VOLT™ Mini Fragment Plating System is a family of implantable devices, consisting of non-contoured, non-anatomic straight and shaped plates (Adaption, Adaption Combi, Compact Straight, Straight Condylar, Hook, T-Plate, Tine, Y-Plate and Triangle), with variable angle screw holes, and two screw types (cortex and locking screws). The system is available in three sizes; 2.0mm, 2.4mm and 2.7mm. The Triangle Plate is available in 2.4mm and 2.7mm sizes only.
The plates of this system are available in Stainless Steel and Commercially Pure Titanium, whilst the corresponding screws are available in Stainless Steel and Titanium Alloy (TAV) respectively. Plates and screws within the VOLT™ Mini Fragment Plating System are available either sterile or non-sterile and are single-use only.
DePuy Synthes VOLT™ Small Fragment Plating System
The DePuy Synthes VOLT™ Small Fragment Plating System is a family of implantable devices consisting of 3.5mm non-contoured, non-anatomic plates with variable angle screw holes. and 3.5mm locking, 3.5mm cortex, and 4.0mm cancellous screws.
The plates of this system are available in Stainless Steel and Titanium, whilst the corresponding screws are available in Stainless Steel and Titanium Alloy (TAV). Plates and screws within the VOLT™ Small Fragment Plating System are available either sterile or non-sterile and are single-use only
The provided text is a 510(k) summary for the DePuy Synthes VOLT Mini Fragment Plating System and VOLT Small Fragment Plating System. This document describes the device, its indications for use, and a comparison to predicate devices, focusing on non-clinical performance testing (mechanical and engineering analyses) to demonstrate substantial equivalence.
Crucially, this document explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence."
Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set details), which are typically found in clinical performance studies validating AI/ML-based medical devices, is not applicable to this submission.
This 510(k) clearance is based on the devices being "substantially equivalent" to existing predicate devices, primarily demonstrated through non-clinical performance testing (mechanical simulations and analyses), rather than clinical trials or studies involving human data and AI algorithm performance.
Therefore, I cannot provide the requested information as it is not present in the provided text. The device in question is a physical orthopedic implant, not an AI/ML software device that would require such performance evaluations.
{0}------------------------------------------------
March 21, 2024
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 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.
DePuy Synthes Jeffrey Krawiec Senior Regulatory Affairs Program Lead 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K233665
Trade/Device Name: DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: February 21, 2024 Received: February 21, 2024
Dear Jeffrey Krawiec:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
{1}------------------------------------------------
K233665 - Jeffrey Krawiec
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Shumaya Ali-S
Shumaya Ali, M.P.H. 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K233665
Device Name
DePuy Synthes VOLT™ Mini Fragment Plating System DePuy Synthes VOLT™ Small Fragment Plating System
Indications for Use (Describe) DePuy Synthes VOLT™ Mini Fragment Plating System:
The VOLT™ Mini Fragment Plating System is indicated for internal fracture fixation of bones and bone fragments of the appendicular skeleton appropriate for the implant size.
The VOLT™ Mini Fragment Plating System is intended for adults and both children (2-12 years) and adolescents (12-21 years) in which growth plates (physes) have fused or in which unfused growth plates will not be compromised by fixation.
If used in the femur, tibia, humerus, patella, or pelvis the VOLT™ Mini Fragment Plating System can only be used for non-load bearing stabilization and reduction.
DePuy Synthes VOLT™ Small Fragment Plating System:
The VOLT Small Fragment Plating System is indicated for internal fracture fixation of bones and bone fragments of the appendicular skeleton appropriate for the implant size.
The VOLT Small Fragment Plating System is intended for adults and both children (2-12 years) and adolescents (12-21 years) in which growth plates (physes) have fused or in which unfused growth plates will not be compromised by fixation.
If used in the femur the VOLT Small Fragment Plating System can only be used for non-load bearing stabilization and reduction.
| 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:
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
| Sponsor | Synthes (USA) Products, LLC1301 Goshen ParkwayWest Chester, PA 19380 |
|---|---|
| Contact | Jeffrey Krawiec, PhDSenior Regulatory Affairs Program LeadT: +1 484 816 6858E: jkrawiec@its.jnj.com |
| Alternate Contact | Kathryn SchlesingerRegulatory Affairs Specialist IIT: +41 76 503 78 43E: kschlesi@its.jnj.com |
| Date Prepared | November 15, 2023 |
| Proprietary Name | DePuy Synthes VOLT™ Mini Fragment Plating SystemDePuy Synthes VOLT™ Small Fragment Plating System |
| Classification Name | Single/multiple component metallic bone fixation appliances and accessories;Smooth or threaded metallic bone fixation fastener |
| Classification | Class IIRegulation Numbers: 21 CFR §888.3030; 21 CFR §888.3040Product Codes: HRS; HWC |
| Predicate Device | As this is a bundled traditional 510(k) submission and therefore multiple primary predicates are identified below.Primary predicates:K000684 - Small Fragment Dynamic Compression Locking (DCL) System K082807 - Synthes (USA) 3.5 and 4.5 mm Locking Compression Plate System with Expanded Indications K011335 - Synthes One--Third Tubular DCL Plate K033805 - Synthes (USA) 3.5 / 4.5 mm LCP Metaphyseal Plates K131186 - Synthes 2.7mm and 3.5mm Variable Angle LCP Midfoot/Hindfoot System Pre-amendment - Synthes 4.0mm Cancellous Screws K063049 - Synthes (USA) Modular Mini Fragment LCP System K082072 - Synthes (USA) 3.5mm LCP Hook Plate K092247 - Synthes Locking Hand Plates K100776 - Synthes 2.4mm/2.7mm Variable Angle (VA)-LCP Forefoot/Midfoot System K112583 - Synthes Cortical Screws K150099 - Depuy Synthes Variable Angle Locking Hand System (1.3mm and 2.0mm Plates and Screws) |
| Device Description | DePuy Synthes VOLT™ Mini Fragment Plating SystemThe DePuy Synthes VOLT™ Mini Fragment Plating System is a family of implantable devices, consisting of non-contoured, non-anatomic straight and shaped plates (Adaption, Adaption Combi, Compact Straight, Straight |
| Condylar, Hook, T-Plate, Tine, Y-Plate and Triangle), with variable angle screwholes, and two screw types (cortex and locking screws). The system is availablein three sizes; 2.0mm, 2.4mm and 2.7mm. The Triangle Plate is available in2.4mm and 2.7mm sizes only.The plates of this system are available in Stainless Steel and Commercially PureTitanium, whilst the corresponding screws are available in Stainless Steel andTitanium Alloy (TAV) respectively. Plates and screws within the VOLT™ MiniFragment Plating System are available either sterile or non-sterile and aresingle-use only.DePuy Synthes VOLT™ Small Fragment Plating SystemThe DePuy Synthes VOLT™ Small Fragment Plating System is a family ofimplantable devices consisting of 3.5mm non-contoured, non-anatomic plateswith variable angle screw holes. and 3.5mm locking, 3.5mm cortex, and 4.0mmcancellous screws.The plates of this system are available in Stainless Steel and Titanium, whilstthe corresponding screws are available in Stainless Steel and Titanium Alloy(TAV). Plates and screws within the VOLT™ Small Fragment Plating System areavailable either sterile or non-sterile and are single-use only | |
| Indications for Use | DePuy Synthes VOLT™ Mini Fragment Plating SystemThe VOLT™ Mini Fragment Plating System is indicated for internal fracturefixation of bones and bone fragments of the appendicular skeletonappropriate for the implant size.The VOLT™ Mini Fragment Plating System is intended for adults and bothchildren (2-12 years) and adolescents (12-21 years) in which growth plates(physes) have fused or in which unfused growth plates will not becompromised by fixation.If used in the femur, tibia, humerus, patella, or pelvis the VOLT™ MiniFragment Plating System can only be used for non-load bearing stabilizationand reduction.DePuy Synthes VOLT™ Small Fragment Plating SystemThe VOLT™ Small Fragment Plating System is indicated for internal fracturefixation of bones and bone fragments of the appendicular skeletonappropriate for the implant size.The VOLT™ Small Fragment Plating System is intended for adults and bothchildren (2-12 years) and adolescents (12-21 years) in which growth plates(physes) have fused or in which unfused growth plates will not becompromised by fixation. |
| If used in the femur the VOLT™ Small Fragment Plating System can only beused for non-load bearing stabilization and reduction. | |
| Contraindications | No contraindications specific to these devices. |
| Non-ClinicalPerformance Testing | To demonstrate the safety and efficacy of the subject devices and support thesubstantial equivalence to their predicates, the following testing wasperformed:• Computational Finite Element Analysis simulating a mechanical staticbending construct test, demonstrated subject plates were non-inferior regarding their bending moment and stiffness.• Engineering analyses and utilization of the Chapman Equationdemonstrated subject screws were non-inferior screw regarding theirtorsional strength and axial pullout strength.• Assessment in accordance with the FDA Safety and PerformanceGuidance for orthopedic non-spinal bone screws (i.e. "OrthopedicNon-Spinal Metallic Bone Screws and Washers - Performance Criteriafor Safety and Performance Based Pathway (December 2020)")demonstrated the subject screws met the performance criteria fordriving torque.Additionally, Magnetic Resonance compatibility testing has been performed toestablish MR Conditional parameters for the subject VOLT™ Mini Fragment andVOLT™ Small Fragment Plating Systems. |
| Clinical PerformanceData | Clinical testing was not necessary for the determination of substantialequivalence. |
| SubstantialEquivalence | The subject devices have the same intended use and similar indications astheir predicate devices. Additionally, the subject devices are an iteration onprior DePuy Synthes plating systems and are therefore similar in terms ofdesign, material, and fundamental technology.The non-clinical performance data and analytic evaluations included in thispremarket notification demonstrate that any differences in technologicalcharacteristics of the subject device compared to the predicate device do notraise any new questions of safety and effectiveness. The proposed devices areat least as safe and effective as the predicate devices. |
| Conclusion | It is concluded that the information provided demonstrate the substantialequivalence of the subject devices to their predicate devices. |
{4}------------------------------------------------
{5}------------------------------------------------
§ 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.