Baby Gorilla/Gorilla Plating System; Monster Screw System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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. June 5, 2024 Paragon 28, Inc. Edward Wells-Spicer Regulatory Affairs Specialist II 14445 Grasslands Dr Englewood, Colorado 80112 Re: K241262 Trade/Device Name: Baby Gorilla/Gorilla Plating System: Monster Screw 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, HTN Dated: May 3, 2024 Received: May 6, 2024 Dear Edward Wells-Spicer: 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" (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). {1}------------------------------------------------ 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 mediation-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, # Tejen D. Soni -S For Shumaya Ali, MPH 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 Submission Number (if known) K241262 Device Name Baby Gorilla/Gorilla Plating System; Monster Screw System MONSTER Screw System Indications for Use (Describe) The Baby Gorilla/Gorilla Bone Plates and Bone Screws of the Baby Gorilla/Gorilla Plating System are indicated for use in stabilization of fractures or osteotomies; intra and extra articular fractures, ioint depression, and multi-fragmentary fractures: revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus, as well as the fingers, hands, and wrists. The system can be used in both and pediatric patients. Specific examples include: Forefoot: · Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion) - · Metatarsal or phalangeal fractures and osteotomies - · Lesser metatarsal shortening osteotomies (e.g. Weil) - · Fifth metatarsal fractures (e.g. Jones Fracture) Mid/Hindfoot: - · LisFranc Arthrodesis and/or Stabilization - · 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions - · Intercuneiform Fusions - · Navicular-Cuneiform (NC) Fusion - · Talo-Navicular (TN) Fusion - · Calcaneo-Cuboid (CC) Fusion - · Subtalar Fusion - · Medial Column Fusion - · Cuneiform Fracture - · Cuboid Fracture - · Navicular Fracture Ankle: - · Lateral Malleolar Fractures - · Syndesmosis Injuries - · Medial Malleolar Fractures and Osteotomies - · Bi-Malleolar Fractures - · Tri-Malleolar Fractures - · Posterior Malleolar Fractures - · Distal Anterior Tibia Fractures - · Vertical Shear Fractures of the Medial Malleolus - · Pilon Fractures - · Distal Tibia Shaft Fractures - · Distal Fibula Shaft Fractures - · Distal Tibia Periarticular Fractures - · Medial Malleolar Avulsion Fractures - · Lateral Malleolar Avulsion Fractures - · Tibiotalocalcaneal Joint Arthrodesis - · Tibiotalar Joint Arthrodesis - · Tibiocalcaneal Arthrodesis {3}------------------------------------------------ - · Supramalleolar Osteotomy - · Fibular Osteotomy - First metatarsal osteotomies for hallux valgus correction including: - · Opening base wedge osteotomy - · Closing base wedge osteotomy - · Crescentic Osteotomy - · Proximal Osteotomy (Chevron and Rotational Oblique) - · Distal Osteotomy (Chevron/Austin) Arthrodesis of the first metatarsophalangeal joint (MTP) including: - Primary MTP Fusion due to hallux ridgidus and/or hallux valgus - · Revision MTP Fusion - · Revision of failed first MTP Arthroplasty implant - Flatfoot: - · Lateral Column Lengthening (Evans Osteotomy) - · Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy) - · Calcaneal Slide Osteotomy - Charcot: · Medial column fusion (talus, navicular, cuneiform, metatarsal) for neuropathic osteoarthropathy (Charcot) · Lateral column fusion (calcaneus, cuboid, metatarsal) for neuropathic osteoarthropathy (Charcot) In addition, the non-locking, titanium screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture fixation, appropriate for the size of the device. The Monster Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the device. Specific examples include: Fractures and Osteotomies - · Fractures of the tarsals, metatarsals and other fractures of the foot (i.e. LisFranc) - · Avulsion fractures and fractures of the 5th metatarsal (i.e. Jones Fracture) - · Talar fractures - · Ankle fractures - · Navicular fractures - · Fractures of the fibula, malleolus, and calcaneus - · Metatarsal and phalangeal osteotomies - · Weil osteotomy - · Calcaneal osteotomy #### Hallux Valgus Correction - · Fixation of osteotomies (i.e. Akin, Scarf, Chevron) - · Interphalangeal (IP) arthrodesis - · Proximal, midshaft, or distal osteotomy - · Lapidus arthrodesis # Arthrodesis/Deformity Correction - · 1st MTP arthrodesis - · Metatarsal deformity correction - · Tarsometatarsal joint arthrodesis - · Naviculocuneiform joint arthrodesis - · Talonavicular arthrodesis - · Subtalar joint arthrodesis {4}------------------------------------------------ - Triple arthrodesis - Medial column arthrodesis - Subtalar joint distraction arthrodesis - Ankle arthrodesis - Lateralizing calcaneal osteotomy - Lateral column lengthening - Hammertoe Fusion resulting from neuropathic osteoarthropathy (Charcot) such as: - Medial and lateral column - Subtalar, talonavicular, and calcaneocuboid 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." {5}------------------------------------------------ # K241262 510(K) SUMMARY ## Bundled Special 510(k) for Sterile Packed Baby Gorilla Plating System screws, plates and washers, and Sterile Packed Monster Screw System screws and washers: | Manufacturer: | Paragon 28, Inc.<br>14445 Grasslands Dr.<br>Englewood, CO 80112 | | | | |-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--| | Contact: | Edward Wells-Spicer<br>Regulatory Affairs Specialist II<br>Paragon 28, Inc.<br>14445 Grasslands Dr.<br>Englewood, CO 80112<br>Phone: 720-994-5481<br>ewspicer@paragon28.com | | | | | Date Prepared: | June 5, 2024 | | | | | Device Trade<br>Names: | Monster Screw System<br>Baby Gorilla/Gorilla Plating System | | | | | Device Class: | Class II | | | | | Primary<br>Predicate(s): | Baby Gorilla/Gorilla Plating System, Monster Screw System<br>(K231231) | | | | | Additional<br>Predicate(s): | Monster Screw System (K203011) | | | | | Device<br>Description: | Baby Gorilla/ Gorilla Plating System<br>The Baby Gorilla/Gorilla Plating System is comprised of bone<br>plates, threaded bone screws, and washers. Gorilla Plates are<br>offered in “mini” and “standard” set sizes in a variety of shapes<br>based upon the anatomical fixation required. Screws are also<br>offered in “mini” and “standard” sets and, in addition, in locking<br>and non-locking versions. Size-matched washers are available for<br>use with the non-locking screws when the latter are used for<br>fixation without the plates. Size-matched plate washers are also<br>available for use with plate holes when there is no desire to use a<br>screw. The Baby Gorilla/Gorilla Plating System implants are<br>manufactured from medical grade titanium (per ASTM F67),<br>stainless steel (per ASTM E138) and titanium alloy (per ASTM | | | | {6}------------------------------------------------ #### Monster Screw System The Monster Screw System is comprised of threaded bone screws (Ti Alloy or Stainless Steel) offered in 2.0mm to 9.5mm diameters (in 0.5mm increments). In addition, a 2.7mm diameter is also part of the system. The overall screw length ranges from 8mm (for smaller diameters) thru 200mm (for larger diameters). The screws are available in a variety of designs including fully or partially threaded, self-drilling or blunt, cannulated or solid, and headed or headless. Sized-matched washers are also available. | Classification<br>and Product<br>Codes: | Baby Gorilla/<br>Gorilla Plating<br>System | 21 CFR 888.3030; Plate, Fixation, Bone<br>21 CFR 888.3040; Screw, Fixation, Bone<br>21 CFR 888.3030; Washer, Bolt Nut | HRS(Primary)<br>HWC<br>HTN | |-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|----------------------------| | | Monster Screw<br>System | 21 CFR 888.3040; Smooth or<br>threaded metallic bone fixation<br>fastener | HWC (Secondary) | | Indications for<br>Use: | <b>Baby Gorilla/ Gorilla Plating System</b><br>The Baby Gorilla/ Gorilla Bone Plates and Bone Screws of the Baby<br>Gorilla and Gorilla Plating System are indicated for use in<br>stabilization and fixation of fractures or osteotomies; intra and extra<br>articular fractures, joint depression, and multi-fragmentary fractures;<br>revision procedures, joint fusion and reconstruction of small bones of<br>the toes, feet and ankles including the distal tibia, talus, and calcaneus,<br>as well as the fingers, hands, and wrists. The system can be used in<br>both adult and pediatric patients. Specific examples include: | | | | | Forefoot:<br>Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion) Metatarsal or phalangeal fractures and osteotomies Lesser metatarsal fractures (e.g. Weil) Fifth metatarsal fractures (e.g. Jones Fracture) | | | | Indications for<br>Use<br>(continued): | Mid/Hindfoot:<br>LisFranc Arthrodesis and/or Stabilization 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions Intercuneiform Fusions | | | {7}------------------------------------------------ - Talo-Navicular (TN) Fusion ● - Calcaneo-Cuboid (CC) Fusion ● - Subtalar Fusion - Medial Column Fusion ● - Cuneiform Fracture - Cuboid Fracture - Navicular Fracture . #### Ankle - Lateral Malleolar Fractures ● - Syndesmosis Injuries ● - Medial Malleolar Fractures and Osteotomies ● - Bi-Malleolar Fractures - Tri-Malleolar Fractures ● - Posterior Malleolar Fractures ● - Distal Anterior Tibia Fractures ● - Vertical Shear Fractures of the Medial Malleolus ● - . Pilon Fractures - Distal Tibia Shaft Fractures - Distal Fibula Shaft Fractures - Distal Tibia Periarticular Fractures ● - Medial Malleolar Avulsion Fractures - Lateral Malleolar Avulsion Fractures ● - Tibiotalocalcaneal Joint Arthrodesis ● - Tibiocalcaneal Arthrodesis ● - Supramalleolar Osteotomy . - Fibular Osteotomy ● First metatarsal osteotomies for hallux valgus correction including: - Opening base wedge osteotomy ● - Closing base wedge osteotomy ● - Crescentic Osteotomy ● - Proximal Osteotomy (Chevron and Rotational Oblique) ● - Distal Osteotomy (Chevron / Austin) ● Arthrodesis of the first metatarsophalangeal joint (MTP) including: ## Indications for Use - Primary MTP Fusion due to hallux ridgidus and/or hallux valgus # (continued): - Revision MTP Fusion ● - Revision of failed first MTP Arthroplasty implant ● {8}------------------------------------------------ Flatfoot: - Lateral Column Lengthing (Evans Osteotomy) - Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy) - Calcaneal Slide Osteotomy ● #### Charcot: - column fusion (talus, navicular, cuneiform, Medial metatarsal) for neuropathic osteoarthropathy (Charcot) - Lateral column fusion (calcaneus, cuboid, metatarsal) for neuropathic osteoarthropathy (Charcot) In addition, the non-locking titanium screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device. #### Monster Screw System The Monster Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the size of the device. Specific examples include: Fractures and Osteotomies - Fractures of the tarsals, metatarsals and other fractures of the • foot (i.e., LisFranc) - . Avulsion fractures and fractures of the 5th metatarsal (i.e., Jones Fracture) - . Talar fractures - Ankle fractures - . Navicular fractures - . Fractures of the fibula, malleolus, and calcaneus - . Metatarsal and phalangeal osteotomies - . Weil osteotomy - Calcaneal osteotomy ● #### Hallux Valgus Correction - Fixation of osteotomies (i.e., Akin, Scarf, Chevron) ● Proximal, midshaft, or distal osteotomy - Interphalangeal (IP) arthrodesis #### Indications for - . Lapidus arthrodesis . # (continued): Use #### Arthrodesis/Deformity Correction - 1st MTP arthrodesis ● - Metatarsal deformity correction . {9}------------------------------------------------ - Tarsometatarsal joint arthrodesis ● . Naviculocuneiform joint arthrodesis Talonavicular arthrodesis ● • Subtalar joint arthrodesis . Triple arthrodesis • Medial column arthrodesis . Subtalar joint distraction arthrodesis ● Ankle arthrodesis Lateralizing calcaneal osteotomy . . Lateral column lengthening . Hammertoe Fusion resulting from neuropathic osteoarthropathy (Charcot) such as: Medial and lateral column . . Subtalar, talonavicular, and calcaneocuboid The purpose of this Bundled Special 510(k) is to obtain clearance of Substantial sterile packed offerings for the screws, plates and washers of the Baby Equivalence: Gorilla/Gorilla Plating System and the screws and washers of the Monster Screw System. There are no other indications for use, design, material, performance, or labeling modifications subject to the submission. The intended use, principle of operation and fundamental scientific technology of the modified devices are identical to the predicate devices. Results of verification and validation activities demonstrate substantial equivalence and the subject modifications do not raise new issues of safety or effectiveness. Bacterial endotoxin testing, sterilization validation, and a cleaning Performance validation was conducted, and the results meet acceptance criteria of Testing: FDA recognized standards. Conclusions: Monster Screw System The subject device Monster Screw System is substantially equivalent to the previously cleared predicate device Monster Screw System (K231231, K203011). Baby Gorilla/ Gorilla Plating System The subject device Baby Gorilla/Gorilla Plating System is substantially equivalent to the previously cleared predicate device Baby Gorilla/Gorilla Plating System (K231231). The subject devices possess identical indications for use, materials, design, and principles of operation as the predicates. The proposed device modifications (Sterile packed implants for the Baby {10}------------------------------------------------ Gorilla/Gorilla Plating System and Monster Screw System) do not raise new issues of safety or effectiveness. The subject devices are substantially equivalent to the legally marketed, predicate Baby Gorilla/Gorilla Plating System and Monster Screw System.