(29 days)
No
The device description and intended use clearly define a system of bone plates and screws for mechanical fixation. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The performance studies focus on engineering analysis of the physical implants.
Yes
The device is described as a 'Bone Plates and Bone Screws' system indicated for 'stabilization and fixation of fractures or osteotomies; intra articular fractures, joint depression, and multi-fragmentary fractures; revision procedures, joint fusion and reconstruction of small bones'. This directly implies it is used to treat or alleviate a disease or injury, thus classifying it as a therapeutic device.
No
Explanation: This device is an internal fixation system (bone plates and screws) used for stabilization and fixation of fractures or osteotomies. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states that the device consists of physical implants (bone plates and screws) made from titanium and stainless steel. This is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the stabilization and fixation of fractures and osteotomies in bones of the toes, feet, ankles, fingers, hands, and wrists. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as an "internal fixation system" consisting of plates and screws made from medical-grade materials. These are implants designed to be placed inside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support and fixation.
N/A
Intended Use / Indications for Use
The Baby Gorilla®/Gorilla® Bone Plates and Bone Screws of the Baby Gorilla®/Plating System are indicated for use in stabilization and fixation of fractures or osteotomies; intra 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, 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 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 Fusions
- · 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
- · 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 repair and fracture fixation, appropriate for the device.
Product codes
HRS, HWC, HTN
Device Description
The Baby Gorilla®/Gorilla® Plating System implants are internal fixation systems. 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 "min" and "standard" sets and, in addition, in locking and non-locking versions. Size-matched washers are available for use with the non-locking 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
toes, feet, ankles including the distal tibia, talus, calcaneus, fingers, hands, wrists
Indicated Patient Age Range
adult and pediatric patients
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)
Engineering analysis is presented to provide evidence that the original testing and subsequent performance is not adversely affected by the modifications to the subject devices.
The results of the analysis demonstrated the modified designs are substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Baby Gorilla®/Gorilla® Plating System (K203511)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
July 17, 2022
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Paragon 28, Inc. Haylie Hertz Sr. Regulatory Affairs Specialist 14445 Grasslands Dr. Englewood, Colorado 80112
Re: K221465
Trade/Device Name: Baby Gorilla®/Gorilla® 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. HTN Dated: May 17, 2022 Received: May 19, 2022
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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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, 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
Enclosure
2
Indications for Use
510(k) Number (if known)
K221465
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 and fixation of fractures or osteotomies; intra 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, 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 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 Fusions
- · 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 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)
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4
510(k) Summary
| Device Trade Name: | Baby Gorilla®/Gorilla® Plating System |
|---|---|
| Manufacturer: | Paragon 28, Inc. |
| 14445 Grasslands Dr. | |
| Englewood, CO 80112 | |
| Contact: | Ms. Haylie Hertz |
| Sr. Regulatory Affairs Specialist | |
| Phone: 303.720.0017 | |
| hhertz@paragon28.com | |
| Date Prepared: | June 13, 2022 |
| Classification: | 21 CFR §888.3030, Single/Multiple Component Metallic Bone |
| Fixation Appliances And Accessories (Primary) | |
| 21 CFR §888.3040, Smooth or threaded metallic bone fixation | |
| fastener | |
| 21 CFR §888.3030, Single/Multiple Component Metallic Bone | |
| Fixation Appliances And Accessories | |
| Class: | II |
| Product Code: | HRS, HWC, HTN |
| Common Name: | Bone Plate, Bone Screw, Bone Washer |
| Predicate Device: | Baby Gorilla®/Gorilla® Plating System (K203511) |
Indications for Use:
The Baby Gorilla®/Gorilla® Bone Plates and Bone Screws of the Baby Gorilla®/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 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 ●
5
K221465 Page 2 of 4
- 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 ●
- 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 ●
6
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.
Device Description:
The Baby Gorilla®/Gorilla® Plating System implants are internal fixation systems. 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 "min" and "standard" sets and, in addition, in locking and non-locking versions. Size-matched washers are available for use with the non-locking 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).
Substantial Equivalence:
The subject Baby Gorilla®/Gorilla® Plating System and the predicate system are intended to be used for stabilization and fixation of fractures, osteotomies, revision procedures, joint fusion, and reconstruction of bones. The indications for the subject device are identical to the indications of the predicate device.
The subject Baby Gorilla®/Gorilla® Plating System components possess the same technological characteristics as the predicate device. These include:
- . performance,
- basic design, ●
- material, manufacturing and
- sizes (dimensions are comparable to those offered by the predicate systems). ●
Differences between the Baby Gorilla®/Gorilla® Plating System implants and the predicate devices were shown not to raise new questions of safety and effectiveness. Therefore, the fundamental scientific technology of the subject Baby Gorilla®/Gorilla® Plating System components is similar to previously cleared device.
Performance Data:
Engineering analysis is presented to provide evidence that the original testing and subsequent performance is not adversely affected by the modifications to the subject devices.
The results of the analysis demonstrated the modified designs are substantially equivalent to the predicate devices.
Conclusion:
The modified Baby Gorilla®/Gorilla® Plating System possessed the same indications for use and technological characteristics as the predicate Baby Gorilla®/Gorilla Plating System (K203511).
7
Therefore, the Baby Gorilla®/Gorilla® Plating System is substantially equivalent to the predicate device with respect to indications for use, technical characteristics, and function.