(167 days)
No
The document describes various orthopedic implants and systems for bone fixation and replacement. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML. The performance studies focus on MR safety and compatibility, which are standard tests for implantable devices, not AI/ML performance metrics.
Yes
Explanation: The devices described are surgical implants and systems (e.g., screws, plates, nails, total ankle replacement) used for various orthopedic procedures such as fracture repair, fusion, and reconstruction. These are clearly intended to treat or alleviate a medical condition, which is the definition of a therapeutic device.
No
Explanation: The provided text describes several types of orthopedic implants (screws, plates, nails, artificial joints) used for fixation, stabilization, fusion, and replacement in bone reconstruction and fracture repair. These devices are therapeutic, not diagnostic.
No
The device description clearly outlines various hardware components including screws, plates, nails, and implants made of materials like titanium and stainless steel. The intended use also describes surgical procedures involving these physical devices.
Based on the provided information, none of these devices are IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens derived from the human body. This includes things like blood, urine, tissue samples, etc., to provide information for diagnosis, monitoring, or screening.
- The devices described are surgical implants and instruments. Their intended use is for the physical repair, stabilization, and reconstruction of bones and joints within the human body. They are used in vivo (within a living organism), not in vitro (in glass, or outside the body).
The descriptions clearly state their purpose is for procedures like fracture repair, arthrodesis, osteotomy, and joint replacement, all of which are surgical interventions performed directly on the patient.
N/A
Intended Use / Indications for Use
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), 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, 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 Baby Gorilla® / Gorilla® Bone Plates and Bone Screws of the Baby Gorilla® and Gorilla® Plating System are indicated for use in stabilization and fixation of fractures or osteotomies; intra and extra articular fractures, joint 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 adult and pediatric patients. Specific examples include: Forefoot: (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)); 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, 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: (Primary MTP Fusion due to hallux ridgidus and/or hallux valgus, Revision MTP Fusion, Revision of failed first MTP Arthroplasty implant); Flatfoot: (Lateral Column Lengthing (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 repair and fracture fixation, appropriate for the size of the device.
The Phantom® Small Bone Intramedullary Nail System is indicated for use in stabilization and fixation of the small bones of the feet and ankle for the treatment of fractures, osteotomies, nonunions, pseudarthroses and malunions by revision, joint fusion or reconstruction procedures.
The Phantom® Hindfoot TTC/TC Nail System is indicated for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include: (Post-traumatic or degenerative arthritis, Previously infected arthrosis, Revision of failed ankle arthrodesis, Revision of failed total ankle arthroplasty, Talar deficiency conditions such as avascular necrosis of the talus (requiring tibiocalcaneal arthrodesis), Neuromuscular deformity or other neuromuscular disease with severe deformity or instability of the ankle, Rheumatoid arthritis, Osteoarthritis, Nonunions or pseudarthrosis of hindfoot and distal tibia, Trauma (severe or malunited tibial pilon fracture), Charcot foot (neuroarthropathy), Severe end-stage degenerative arthritis, Instability and skeletal defects after tumor resection, Pantalar arthrodesis, Severe foot/ankle deformity).
The HammerTube™ System is indicated for fixation of The reconstruction and fusion of toes during correction procedures for hammertoe deformity, claw toe deformity, shortening osteotomies of the phalanges and mallet toe deformity as well as revision hammertoe procedures. The cannulated and solid HammerTube™ implants may be used without any other additional device. The cannulated implants may be used with K-Wires for delivery of implants or for the temporary stabilization of nearby joints, such as the metatarsophalangeal joint. The implantable K-Wires are indicated for use in the stabilization and fixation of small bones for use in bone reconstruction, osteotomy, arthrodesis, fracture repair and fixation, appropriate for the size of the joint. Additionally, the implantable K-Wires are indicated as guide pines for insertion of instruments and implants in the HammerTube™ System.
The APEX 3D™ Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. Components are intended for cemented use only.
Product codes
HWC, HRS, HTN, KTW, HSB, HTY, HSN
Device Description
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.
Baby Gorilla® / Gorilla® Plating System: The Baby Gorilla® / Gorilla® Plating System is comprised of bone plates, threaded bone screws, and washers. Gorilla® Plates are offered in "mini" and "standard" set sizes in a variety of shapes based upon the anatomical fixation required. Screws are also offered in "mini" and "standard" sets and, in addition, in locking and non-locking versions. Size-matched washers are available for use with the non0locking screws when the latter are used for fixation without the plates. Size-matched plate washers are also available for use with plate holes when there is no desire to use a screw. The Baby Gorilla® / Gorilla® Plating System implants are manufactured from medical grade titanium (per ASTM F67), stainless steel (per ASTM F138), and titanium alloy (per ASTM F136).
Phantom® Small Bone Intramedullary Nail System: The Phantom® Small Bone Intramedullary Nail System is comprised of small bone intramedullary nails, locking screws and threaded pegs. The Phantom® nails are offered in a variety of lengths to accommodate variations in patient anatomy. The Phantom® threaded pegs and locking screws insert through the intramedullary nail to secure the construct. These are offered in varving lengths to accommodate the anatomical fixation required. The system includes instruments for implantation.
Phantom® Hindfoot TTC/TC Nail System: The Phantom® Hindfoot TTC/TC Nail System is comprised of intramedullary nails, screws and accessory components. The Phantom® nails are offered in a variety of sizes lengths, and configurations to accommodate variations in patient anatomy. The Phantom® screws insert through the intramedullary nail to secure the construct. These are offered in varying lengths to accommodate the anatomical fixation required.
HammerTube™ System: The HammerTube™ System includes HammerTube™ and K-Wire implants. The HammerTube™ is a commercially pure titanium plasma sprayed PEEK cylinder in varying diameters, lengths, and angles. The K-Wires are stainless steel and double trocar pointed. The implants are sold sterile.
APEX 3D™ Total Ankle Replacement System: The APEX 3D™ Total Ankle Replacement System is a cemented, fixed bearing device comprised of a tibial component, a talar component and an Ultra-High Molecular Weight Polyethylene (UHMWPE) component used for ankle joint replacement. Components are available in varying sizes and design configurations intended for both primary and revision applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR) / Magnetic Resonance Imaging (MRI)
Anatomical Site
Foot, Ankle, Toes, Fingers, Hands, Wrists
Indicated Patient Age Range
Adult and Pediatric patients (for Baby Gorilla® / Gorilla® Plating System); Not specified for other devices.
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)
MR Safety and Compatibility Testing has been completed and presented in the submission as recommended in the FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" issued May 20, 2021, including FDA-recognized standards tests for the following potential hazards:
- Image Artifact per ASTM F2119 Test Method for Evaluation of MR Image Artifacts from Passive Implants
- Magnetically Induced Displacement Force per ASTM F2052 Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
- Magnetically Induced Torque per ASTM F2213 Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
- Radiofrequency (RF) Induced Heating per ASTM F2182 Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants during Magnetic Resonance Imaging
Based on the results, each device will be labeled as "MR Conditional" with MRI Safety Information in the instructions for use as described in ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Monster® Screw System (K203011), Baby Gorilla® / Gorilla® Plating System (K222194), Phantom® Small Bone Intramedullary Nail System (K182307), Phantom® Hindfoot TTC/TC Nail System (K210869), HammerTube™ System (K171715), APEX 3D™ Total Ankle Replacement System (K210390)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
October 12, 2023
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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Paragon 28 Inc. Havlie Hertz Associate Manager of Regulatory Affairs 14445 Grasslands Dr. Englewood, Colorado 80112
Re: K231231
Trade/Device Name: MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, HRS, HTN, KTW, HSB, HTY, HSN Dated: September 12, 2023 Received: September 13, 2023
Dear Haylie Hertz:
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.
1
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).
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, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair
2
and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure: List of Cleared Devices in K231231
List of Cleared Devices in K231231
-
- Monster® Screw System MR Conditional
-
- Baby Gorilla®/Gorilla® Plating System MR Conditional
-
- Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System -MR Conditional
-
- Phantom® Hindfoot TTC/TC Nail System MR Conditional
-
- HammerTube System MR Conditional
-
- Apex 3D Total Ankle Replacement System- MR Conditional
3
510(k) Number (if known)
K231231
Device Name Monster Screw System
Indications for Use (Describe)
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)
- · 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
- · 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)
4
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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5
510(k) Number (if known)
K231231
Device Name Baby Gorilla / Gorilla Plating System
Indications for Use (Describe)
The Baby Gorilla® / Gorilla® Bone Plates and Bone Screws of the Baby Gorilla® Plating System are indicated for use in stabilization of fractures or osteotomies; intra and extra articular fractures, joint 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 adult and pediatric patients. Specific examples include:
Forefoot:
- · 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)
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
- · Tibiocalcaneal Arthrodesis
- Supramalleolar Osteotomy
6
· 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 Lengthing (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 repair and fracture fixation, appropriate for the device.
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
7
510(k) Number (if known)
Device Name
Phantom Small Bone Intramedullary Nail System
Indications for Use (Describe)
The Phantom® Small Bone Intramedullary Nail System is indication and fixation and fixation of the small bones of the feet and ankle for the treatment of fractures, osteotomies, pseudarthroses and malunions by revision, joint fusion or reconstruction procedures.
|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
8
510(k) Number (if known)
K231231
Device Name Phantom Hindfoot TTC/TC Nail System
Indications for Use (Describe)
The Phantom® Hindfoot TTC/TC Nail System is intended for tibiotalocalcaneal arthrodesss (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include:
- · Post-traumatic or degenerative arthritis
- · Previously infected arthrosis
- Revision of failed ankle arthrodesis
- · Revision of failed total ankle arthroplasty
- · Talar deficiency conditions such as avascular necrosis of the talus (requiring tibiocalcaneal arthrodesis)
- · Neuromuscular deformity or other neuromuscular disease with severe deformity or instability of the ankle
- · Rheumatoid arthritis
- · Osteoarthritis
- Nonunions or pseudarthrosis of hindfoot and distal tibia
- · Trauma (severe or malunited tibial pilon fracture)
- · Charcot foot (neuroarthropathy)
- · Severe end-stage degenerative arthritis
- · Instability and skeletal defects after tumor resection
- · Pantalar arthrodesis
- · Severe foot/ankle deformity
Type of Use (Select one or both, as applicable)
| ☑ 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
9
510(k) Number (if known)
K231231
Device Name Phantom Hindfoot TTC/TC Nail System
Indications for Use (Describe)
The Phantom® Hindfoot TTC/TC Nail System is indicated for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include:
- · Post-traumatic or degenerative arthritis
- · Previously infected arthrosis
- Revision of failed ankle arthrodesis
- · Revision of failed total ankle arthroplasty
- · Talar deficiency conditions such as avascular necrosis of the talus (requiring tibiocalcaneal arthrodesis)
- · Neuromuscular deformity or other neuromuscular disease with severe deformity or instability of the ankle
- Rheumatoid arthritis
- · Osteoarthritis
- Nonunions or pseudarthrosis of hindfoot and distal tibia
- · Trauma (severe or malunited tibial pilon fracture)
- · Charcot foot (neuroarthropathy)
- · Severe end-stage degenerative arthritis
- Instability and skeletal defects after tumor resection
- · Pantalar arthrodesis
- · Severe foot/ankle deformity
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 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
10
510(k) Number (if known)
Device Name APEX 3D Total Ankle Replacement System
Indications for Use (Describe)
The APEX 3D™ Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. In the United States, components are intended for cemented use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ 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
11
K231231 510(K) SUMMARY
Bundled Traditional 510(k) for MR Safety and Compatibility Testing and Labeling Updates for Paragon 28 Orthopedic Fixation Devices:
510(k) Number: K231231
- Manufacturer: Paragon 28, Inc. 14445 Grasslands Dr. Englewood, CO 80112
- Haylie Hertz Contact: Associate Manager of Regulatory Affairs Paragon 28, Inc. 14445 Grasslands Dr. Englewood, CO 80112 Phone: 303-720-0017 hhertz@paragon28.com
- Date Prepared: October 10, 2023
- Device Trade Monster® Screw System Baby Gorilla® / Gorilla® Plating System Names: Phantom® Small Bone Intramedullary Nail System Phantom® Hindfoot TTC/TC Nail System HammerTube™ System APEX 3D™ Total Ankle Replacement System
Device Class: Class II
- Primary Monster® Screw System (K203011)
- Predicate:
- Baby Gorilla® / Gorilla® Plating System (K222194) Additional Phantom® Small Bone Intramedullary Nail System (K182307) Predicates: Phantom® Hindfoot TTC/TC Nail System (K210869) HammerTube™ System (K171715) APEX 3D™ Total Ankle Replacement System (K210390)
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| Device | Monster® Screw System |
|---|---|
| Description: | 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. |
Baby Gorilla® / Gorilla® Plating System
The Baby Gorilla® / Gorilla® Plating System is comprised of bone plates, threaded bone screws, and washers. Gorilla® Plates are offered in "mini" and "standard" set sizes in a variety of shapes based upon the anatomical fixation required. Screws are also offered in "mini" and "standard" sets and, in addition, in locking and non-locking versions. Size-matched washers are available for use with the non0locking screws when the latter are used for fixation without the plates. Size-matched plate washers are also available for use with plate holes when there is no desire to use a screw. The Baby Gorilla® / Gorilla® Plating System implants are manufactured from medical grade titanium (per ASTM F67), stainless steel (per ASTM F138), and titanium alloy (per ASTM F136).
Phantom® Small Bone Intramedullarv Nail System
The Phantom® Small Bone Intramedullary Nail System is comprised of small bone intramedullary nails, locking screws and threaded pegs. The Phantom® nails are offered in a variety of lengths to accommodate variations in patient anatomy. The Phantom® threaded pegs and locking screws insert through the intramedullary nail to secure the construct. These are offered in varving lengths to accommodate the anatomical fixation required. The system includes instruments for implantation.
Phantom® Hindfoot TTC/TC Nail System
The Phantom® Hindfoot TTC/TC Nail System is comprised of intramedullary nails, screws and accessory components. The Phantom® nails are offered in a variety of sizes lengths, and configurations to accommodate variations in patient anatomy. The Phantom® screws insert through the intramedullary nail to secure the construct. These are offered in varying lengths to accommodate the anatomical fixation required.
HammerTube™ System
The HammerTube™ System includes HammerTube™ and K-Wire implants. The HammerTube™ is a commercially pure titanium
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| Device | plasma sprayed PEEK cylinder in varying diameters, lengths, and |
|---|---|
| Description | angles. The K-Wires are stainless steel and double trocar pointed. The |
| (continued): | implants are sold sterile. |
APEX 3D Total Ankle Replacement System
The APEX 3D™ Total Ankle Replacement System is a cemented, fixed bearing device comprised of a tibial component, a talar component and an Ultra-High Molecular Weight Polyethylene (UHMWPE) component used for ankle joint replacement. Components are available in varying sizes and design configurations intended for both primary and revision applications.
| Classification
and Product
Codes: | Monster® Screw
System | 21 CFR 888.3040; Smooth or
threaded metallic bone fixation
fastener | HWC |
|-----------------------------------------|---------------------------------------------------------|--------------------------------------------------------------------------------------------|-----|
| | Baby Gorilla® /
Gorilla® Plating
System | 21 CFR 888.3030; Plate, Fixation,
Bone | HRS |
| | | 21 CFR 888.3040; Screw, Fixation,
Bone | HWC |
| | | 21 CFR 888.3030; Washer, Bolt Nut | HTN |
| | Phantom® Small
Bone
Intramedullary
Nail System | 21 CFR 888.3040; Smooth or
threaded metallic bone fixation
fastener | HWC |
| | | 21 CFR 888.3030; Appliance,
fixation, nail/blade/plate
combination, single component | KTW |
| | Phantom®
Hindfoot TTC/TC
Nail System | 21 CFR 888.3020; Rod, fixation,
intramedullary and accessories | HSB |
| | | 21 CFR 888.3040; Smooth or
threaded metallic bone fixation
fastener | HWC |
| | HammerTube™
System | 21 CFR 888.3040; Pin, Fixation,
Smooth | HTY |
| | APEX 3D™
Total Ankle
Replacement
System | 21 CFR 888.3110; Prosthesis, Ankle,
Semi-Constrained, Cemented,
Metal/Polymer | HSN |
Indications for Monster® Screw System
Use:
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:
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| Indications for Use (continued): | 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
• 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
Baby Gorilla® / Gorilla® Plating System
The Baby Gorilla® / Gorilla® Bone Plates and Bone Screws of the Baby Gorilla® and Gorilla® Plating System are indicated for use in stabilization and fixation of fractures or osteotomies; intra and extra articular fractures, joint depression, and multi-fragmentary fractures; |
| ---------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
the toes, feet and ankles including the distal tibia, talus, and calcaneus,
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Indications for as well as the fingers, hands, and wrists. The system can be used in both adult and pediatric patients. Specific examples include: Use (continued):
Forefoot:
- 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) ●
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
- Tibiocalcaneal Arthrodesis .
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- Supramalleolar Osteotomy
- Fibular Osteotomy ●
(continued):
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 Lengthing (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 repair and fracture fixation, appropriate for the size of the device.
Phantom® Small Bone Intramedullary Nail System
The Phantom® Small Bone Intramedullary Nail System is indicated for use in stabilization and fixation of the small bones of the feet and ankle for the treatment of fractures, osteotomies, nonunions, pseudarthroses and malunions by revision, joint fusion or reconstruction procedures.
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Phantom® Hindfoot TTC/TC Nail System
The Phantom® Hindfoot TTC/TC Nail System is indicated for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot.
Examples of specific indications include:
- Post-traumatic or degenerative arthritis
- Previously infected arthrosis
- . Revision of failed ankle arthrodesis
- Revision of failed total ankle arthroplasty
- . Talar deficiency conditions such as avascular necrosis of the talus (requiring tibiocalcaneal arthrodesis)
- Neuromuscular deformity or other neuromuscular disease with severe deformity or instability of the ankle
- Rheumatoid arthritis
- . Osteoarthritis
- Nonunions or pseudarthrosis of hindfoot and distal tibia
- Trauma (severe or malunited tibial pilon fracture)
- Charcot foot (neuroarthropathy)
- . Severe end-stage degenerative arthritis
- . Instability and skeletal defects after tumor resection
- . Pantalar arthrodesis
- . Severe foot/ankle deformity
HammerTube™ System
HammerTube™M System is indicated for fixation of The reconstruction and fusion of toes during correction procedures for hammertoe deformity, claw toe deformity, shortening osteotomies of the phalanges and mallet toe deformity as well as revision hammertoe procedures.
The cannulated and solid HammerTube™ implants may be used without any other additional device. The cannulated implants may be used with K-Wires for delivery of implants or for the temporary stabilization of nearby joints, such as the metatarsophalangeal joint.
The implantable K-Wires are indicated for use in the stabilization and fixation of small bones for use in bone reconstruction, osteotomy, arthrodesis, fracture repair and fixation, appropriate for the size of the joint. Additionally, the implantable K-Wires are indicated as guide pines for insertion of instruments and implants in the HammerTube™ System.
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APEX 3D™ Total Ankle Replacement System
The APEX 3D™ Total Ankle Replacement System is indicated as a total ankle replacement in primary surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. Revision surgery for these patients is also indicated for patients with sufficient bone stock present. Components are intended for cemented use only.
- The purpose of this Bundled Traditional 510(k) is to obtain clearance Substantial of Magnetic Resonance (MR) safety and compatibility testing and Equivalence: Magnetic Resonance Imaging (MRI) Safety Information updates to the labeling of the previously cleared and legally marketed Paragon 28 Orthopedic Fixation Devices. There are no other indications for use, design, material, processing, 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. The MR safety and compatibility performance and labeling modifications were accomplished via testing in the MRI environment and updated labeling per the FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" issued May 20, 2021. The data demonstrate substantial equivalence and the subject modifications do not raise new issues of safety or effectiveness.
MR Safety and Compatibility Testing has been completed and Performance presented in the submission as recommended in the FDA Guidance Testing: "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" issued May 20, 2021, including FDArecognized standards tests for the following potential hazards:
- Image Artifact per ASTM F2119 Test Method for Evaluation ● of MR Image Artifacts from Passive Implants
- Magnetically Induced Displacement Force per ASTM F2052 Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
- Magnetically Induced Torque per ASTM F2213 Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
- Radiofrequency (RF) Induced Heating per ASTM F2182 Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants during Magnetic Resonance Imaging
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Based on the results, each device will be labeled as "MR Conditional" with MRI Safety Information in the instructions for use as described in ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.
Monster® Screw System Conclusions: The subject device Monster® Screw System is substantially equivalent to the previously cleared predicate device Monster® Screw System (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 (K222194).
Phantom® Small Bone Intramedullary Nail System
The subject device Phantom® Small Bone Intramedullary Nail System is substantially equivalent to the previously cleared predicate device Phantom® Small Bone Intramedullary Nail System (K182307).
Phantom® Hindfoot TTC/TC Nail System
The subject device Phantom® Hindfoot TTC/TC Nail System is substantially equivalent to the previously cleared predicate device Phantom® Hindfoot TTC/TC Nail System (K210869).
HammerTube™ System
The subject device HammerTube™ System is substantially equivalent to the previously cleared predicate device HammerTube™ System (K171715).
APEX 3D™ Total Ankle Replacement System
The subject device APEX 3D™ Total Ankle Replacement System is substantially equivalent to the previously cleared predicate device APEX 3D™ Total Ankle Replacement System (K210390).
The subject devices possess identical indications for use, technological characteristics, and principles of operation as the predicates. The proposed device modification (MR Conditional patient safety information) does not raise new issues of safety or effectiveness and has been fully evaluated per the FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" issued May 20, 2021. The subject devices are substantially equivalent to the legally marketed, predicate Paragon 28 Orthopedic Fixation Devices.