Forma Medical Optimal Plating System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. June 26, 2024 Forma Medical, Inc. % Jennifer Palinchik President JALEX Medical, LLC 27865 Clemens Rd., Suite 3 Westlake, Ohio 44145 Re: K234059 Trade/Device Name: Forma Medical Optimal 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: June 21, 2024 Received: June 21, 2024 Dear Jennifer Palinchik: 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}------------------------------------------------ ## K234059 - Jennifer Palinchik (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 Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) K234059 Device Name Forma Medical Optimal Plating System Indications for Use (Describe) The Forma Medical Optimal Plating System is intended for fixation of fractures, osteotomies, arthrodeses, and bone reconstructions in adult patients with normal or osteopenic bone. Indications include flat (scapula), long (clavicle, upper and lower extremities including metacarpals, and phalanges), irregular (pelvis, hand, foot) bones and joints (wrist, ankle). The Forma Medical Optimal Plating System is not indicated for ribs, sternum, spine, or the skull. 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Forma Medical. The logo consists of a geometric design on the left and the words "FORMA MEDICAL" on the right. The geometric design is made up of three overlapping triangles, with the outer triangle in teal and the inner triangles in gray. The word "FORMA" is in gray, and the word "MEDICAL" is in teal. # 510(k) Summary | Submitted By: | Forma Medical, Inc.<br>3401 Hartzdale Drive<br>Suite 103B, Unit #611<br>Camp Hill, PA 17011 | |-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------| | Date: | 06/21/2024 | | Contact Person: | Jennifer Palinchik, President, JALEX Medical | | Contact Telephone: | (440) 935-3282 | | Contact Fax: | (440) 933-7839 | | Device Trade Name: | Forma Medical Optimal Plating System | | Common Name: | Plate, Fixation, Bone<br>Screw, Fixation, Bone | | Device Classification Name: | Single/multiple component metallic bone fixation appliances and<br>accessories<br>Smooth or threaded metallic bone fixation fastener | | Device Classification: | Class II | | Reviewing Panel: | Orthopedic | | Product Code: | HRS, HWC | | Primary Predicate Device: | Globus Medical ANTHEM® Fracture System (K180554) | | Reference Device: | Nova Step Airlock® (K151277, K143523)<br>APTUS Foot System (K142581) | ### Device Description: The Forma Medical Optimal Plating System is designed to hold bones in relative stability for fracture fixation and arthrodesis. The plates and screws are available in multiple sizes based on patient anatomy and clinical application. The screws are manufactured from titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F67, F136, F1537, and F138. The plates are manufactured from titanium, titanium alloy, or stainless steel, as specified in ASTM F67, F136, and F138. The system includes plates, screws and instruments. The system instrumentation is manufactured from stainless steel, aluminum, and other surgical grade materials. ### Indications for Use: The Forma Medical Optimal Plating System is intended for fixation of fractures, osteotomies, arthrodeses, and bone reconstructions in adult patients with normal or osteopenic bone. Indications include flat (scapula), long (clavicle, upper and lower extremities including metacarpals, and phalanges), irregular (pelvis, hand, foot) bones and joints (wrist, ankle). The Forma Medical Optimal Plating System is not indicated for ribs, sternum, spine, or the skull. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Forma Medical. The logo consists of a geometric shape on the left and the words "FORMA MEDICAL" on the right. The geometric shape is made up of three overlapping triangles, with the outer triangles in teal and the inner triangles in gray. The word "FORMA" is in gray, and the word "MEDICAL" is in teal. ## Summary of Technological Characteristics: The Forma Optimal Plating System and the predicates have intended use and fundamental scientific technology. All devices compare similarly in: - · Design features - Intended use . - Materials . - Dimensions . - Function . | Item | Forma Medical Optimal<br>Plating System | Globus Medical<br>ANTHEM® Fracture System<br>(K180554) | Nova Step<br>Airlock®<br>(K151277, K143523) | APTUS Foot System<br>(K142581) | Comparison | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification<br>Name | Single/multiple component<br>metallic bone fixation<br>appliance and accessories<br>Smooth or threaded metallic<br>bone fixation fastener | Single/multiple component<br>metallic bone fixation appliance<br>and accessories<br>Smooth or threaded metallic<br>bone fixation fastener | Single/multiple<br>component metallic bone<br>fixation appliance and<br>accessories | Single/multiple component<br>metallic bone fixation<br>appliance and accessories | Equivalent | | Regulation | 888.3030, 888.3040 | 888.3030, 888.3040 | 888.3030 | 888.3030 | Equivalent | | Product Code | HRS, HWC | HRS, HWC | HRS | HRS, HWC | Equivalent | | Indications<br>for Use | The Forma Medical Optimal<br>Plating System is intended<br>for fixation of fractures,<br>osteotomies, arthrodeses, and<br>bone reconstructions in adult<br>patients with normal or<br>osteopenic bone. Indications<br>include flat (scapula), long<br>(clavicle, upper and lower<br>extremities including<br>metacarpals, metatarsals, and<br>phalanges), irregular (pelvis,<br>hand, foot) bones and joints<br>(wrist, ankle). The Forma<br>Medical Optimal Plating<br>System is not indicated for | The ANTHEM® Fracture<br>System is indicated for fixation<br>of fractures, osteotomies,<br>arthrodesis and reconstruction<br>of bones for the appropriate size<br>of the device to be used in adult<br>patients, including the clavicle,<br>scapula, humerus, radius, ulna,<br>small bones (metacarpals,<br>metatarsals, phalanges), wrist,<br>pelvis, femur, tibia, fibula,<br>ankle, and foot.<br>The clavicle hook plate may be<br>used for dislocations of the<br>acromioclavicular joint. Mini<br>fragment plates are also | The Airlock®<br>osteosynthesis plate<br>systems are indicated for<br>stabilization and fixation<br>of fresh fractures,<br>revision procedures, joint<br>fusions and<br>reconstruction of small<br>bones of the hands, feet,<br>wrists and ankles, fingers<br>and toes. The system<br>may be used in both adult<br>and pediatric patients. | The APTUS® Foot System is<br>intended for use in small<br>bones, in particular in<br>fractures, osteotomies and<br>arthrodesis of the tarsals,<br>metatarsals and phalanges. | Equivalent to<br>primary<br>predicate | | | ribs, sternum, spine, or the<br>skull. | indicated for fixation of<br>fractures of the acetabulum,<br>patella, and bone fragments,<br>replantation, malunions and<br>nonunions, and for non-load<br>bearing stabilization and<br>reduction of long bone<br>fragments.<br>Small fragment, mini fragment,<br>proximal tibia, clavicle and<br>distal fibula plates may be used<br>in all pediatric subgroups<br>(except neonates) and small<br>stature adults. Distal radius and<br>mini fragment plates may be<br>used in adolescents (12-21<br>years of age).<br>Plating may be used in patients<br>with osteopenic bone. | | | | | Description | The Forma Optimal Plating<br>System comprises a range of<br>plates and screws created for<br>internal bone fixation. These<br>implants come in a range of<br>sizes and shapes to suit<br>individual patient anatomy<br>and can be either contoured<br>or straight, featuring both<br>locking and non-locking<br>screws. Optimal implants are<br>crafted from materials<br>including titanium, titanium<br>alloy, cobalt chromium<br>molybdenum alloy, or<br>stainless steel, as outlined in<br>ASTM standards F67, F136,<br>F1295, F1472, F1537,<br>F2229, F138, and F139. All<br>implants are designed for<br>single-use only. | The ANTHEM® Fracture<br>System is a family of plates and<br>screws designed to be used for<br>internal bone fixation. The<br>implants are available in<br>various sizes and shapes to<br>accommodate patient anatomy,<br>and may be contoured or<br>straight, with locking and non-<br>locking screws. ANTHEM®<br>implants are manufactured from<br>titanium, titanium alloy, cobalt<br>chromium molybdenum alloy,<br>or stainless steel, as specified in<br>ASTM F67, F136, F1295,<br>F1472, F1537, F2229, F138 and<br>F139. All implants are for<br>single use only. | Airlock® osteosynthesis<br>plate systems are are<br>single-use bone fixation<br>devices intended to be<br>permanently implanted.<br>Plates are designed with<br>different shapes and are<br>made of Titanium (Alloy<br>Ti-6Al-4V ELI).<br>The system uses either<br>3mm or 3,5mm locking<br>and non-locking screws.<br>The drill hole are aligned<br>to make sure there-is no<br>risk of conflict between<br>the screws.<br>The plates vary<br>essentially through<br>different curvatures,<br>lengths, number of holes<br>and shape. | The subject device plates are<br>provided in a variety of<br>anatomical designs, in<br>various lengths, widths and<br>thicknesses. The plate<br>thickness varies from 1.6 mm<br>to 2.0 mm depending on the<br>design. The screw holes of<br>the subject device plates are<br>designed to accommodate<br>appropriately sized subject<br>device screws, or screws<br>presently marketed as part of<br>the APTUS System and<br>previously cleared under<br>K091479. The subject device<br>plates also are compatible<br>with K-wires cleared under<br>K092038. The subject device<br>plates are used with TriLock<br>locking screws and cortical | Equivalent to<br>primary<br>predicate | | | | | | | (nonlocking) screws. All<br>subject device screws are<br>self-tapping and self-drilling<br>and provided in diameters of<br>2.0, 2.8 and 3.5 mm, and in<br>various lengths from 8 to 45<br>mm.<br>The subject device plates are<br>made of commercially pure<br>titanium, Grade 4,<br>conforming to ASTM F67<br>Standard Specification for<br>Unalloyed Titanium for<br>Surgical Implant<br>Applications (UNS R50250,<br>UNS R50400, UNS R50550,<br>UNS R50700). The subject<br>device screws are made of<br>titanium alloy conforming to<br>ASTM F136 Standard<br>Specification for Wrought<br>Titanium-6 Aluminum-4<br>Vanadium ELI (Extra Low<br>Interstitial) Alloy for<br>Surgical Implant<br>Applications (UNS R56401). | | Material | Titanium Alloy,<br>Cobalt Chromium<br>Molybdenum Alloy, and<br>Stainless steel per ASTM<br>F67, F136, F1295, F1472,<br>F1537, F2229, F138 and<br>F139. | Titanium Alloy,<br>Cobalt Chromium Molybdenum<br>Alloy, and<br>Stainless steel per ASTM F67,<br>F136, F1295, F1472, F1537,<br>F2229, F138 and F139. | Titanium (Alloy Ti-6Al-<br>4V ELI). | Titanium Alloy per ASTM<br>F67, ASTM F136 | Equivalent to<br>primary<br>predicate | | Plate Styles | Straight, Contourable, and<br>pre-shaped | Straight, Contourable, and pre-<br>shaped | Straight, Contourable,<br>and pre-shaped | Straight, Contourable, and<br>pre-shaped | Equivalent to<br>primary<br>predicate | | Plate Lengths | 23 to 153mm | 21mm to 155mm | 22.5mm to 53mm | 16 to 76 mm | Equivalent | | Screw Styles | Locking and Non-locking | Locking and Non-locking | Locking and Non-<br>locking | Locking and Non-locking | Equivalent | | Screw<br>Lengths | 6mm to 85mm | 6mm to 85mm | N/A | 8 to 45 mm | Equivalent | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Forma Medical. The logo consists of a geometric symbol on the left and the words "FORMA MEDICAL" on the right. The geometric symbol is made up of three triangles that are intertwined. The word "FORMA" is in dark gray, and the word "MEDICAL" is in teal. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Forma Medical. The logo consists of a geometric design on the left and the words "FORMA MEDICAL" on the right. The geometric design is made up of three overlapping triangles, with the outer triangles in teal and the inner triangle in gray. The word "FORMA" is in gray and the word "MEDICAL" is in teal. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Forma Medical. The logo consists of a stylized teal-colored symbol resembling three interconnected triangles on the left. To the right of the symbol is the text "FORMA" in bold, dark gray letters above the word "MEDICAL" in teal. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Forma Medical. On the left is a teal triangle design with three triangles stacked on top of each other. The word "FORMA" is in dark gray, and the word "MEDICAL" is in teal. ### Mechanical Testing: Substantial equivalence is supported by mechanical evaluation to confirm features, geometry, and performance of the subject devices compared to the predicate devices in torsional strength and insertion/removal torque per ASTM F543, and pullout strength per the Chapman analytical formula, as well as four-point bending per ASTM F382. | | Subject Device | | |-----------------------------------------------------|-------------------------------------------------------------------------------------------------------|--| | | Forma Medical Optimal Plating System | | | Screw: Torsional Strength per<br>ASTM F543-23 | Mechanical testing results demonstrated substantial equivalence to predicate<br>system screws | | | Screw: Insertion/Removal<br>Torque per ASTM F543-23 | Mechanical testing results demonstrated substantial equivalence to predicate<br>system screws | | | Screw: Pullout Strength | Mechanical testing results demonstrated substantial equivalence per the<br>Chapman analytical formula | | | Plate: Four-Point Bending per<br>ASTM F382-17 | Mechanical testing results demonstrated substantial equivalence to predicate<br>system plates | | ### Conclusion: Based on the indications for use, technological characteristics, and mechanical testing comparison with the predicate devices, the subject device has demonstrated substantial equivalence.