(56 days)
Not Found
No
The summary describes a system of bone plates and screws for surgical fixation and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
Explanation: The device, as described in the "Intended Use / Indications for Use" section, is clearly designed to stabilize and fix fractures or osteotomies, assist in joint fusion, and reconstruct small bones. These actions are directly involved in treating medical conditions (fractures, osteotomies) and restoring function in the body, which aligns with the definition of a therapeutic device.
No
The 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 explicitly states that the system includes "implants are internal fixation systems" and describes "plates" and "screws," which are physical hardware components.
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 feet, ankles, 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 bone plates and screws. These are implants used within 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®/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:
- 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 ●
- 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 size of the device.
Product codes (comma separated list FDA assigned to the subject device)
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 "mini" 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
toes, feet and ankles including the distal tibia, talus, and calcaneus, as well as the fingers, hands, and 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K182148, K152974, K151235, K163039, K162674, K163044, K163650, K140792, K140741
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary
| Date: | March 18th, 2019 |
|---|---|
| 510(k) Number: | K190365 |
| Sponsor: | Paragon 28, Inc. |
| 4B Inverness Ct. E., STE 280 | |
| Englewood, Colorado 80112 | |
| Phone: (888) 728-1888 | |
| Fax: (888) 728-1220 | |
| Sponsor contact: | Eric Lintula, Director of Regulatory Affairs |
| Trade Name: | Baby Gorilla®/Gorilla® Plating System |
| Regulatory Class: | Class II |
| Regulation, | |
| Product Code, | |
| Classification, | |
| and Common | |
| Name: | 888.3030, HRS, Plate, Fixation, Bone |
| 888.3040, HWC, Screw, Fixation, Bone | |
| 888.3030, HTN, Washer, Nut Bolt | |
| 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 "mini" | |
| 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. | |
| Compatible | |
| Devices: | K124027, K151418, K153378 Monster® Screw System |
| 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: |
1
- 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 ●
- 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 ●
2
| 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 size of the device. | |
|---|---|
| Materials: | 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). |
| Primary Predicate: | K182148, BABY GORILLA®/GORILLA® Plating System (formerly ParaLock Plating System) |
| K152974, ORTHOLOC® 3Di Foot Plating Reconstruction System | |
| K151235, Medline Foot Plates and Screws | |
| K163039, ORTHOLOC® 3Di Small Bones Plating System | |
| Additional Predicates: | K162674, BioPro Foot Plating Systems |
| K163044, ORTHOLOC® 3Di Ankle Fracture System | |
| K163650, ORTHOLOC® 3Di Ankle Fusion Plating System | |
| K140792, SALVATION™ 3Di Plating System | |
| K140741, SALVATION™ Beams and Bolts System | |
| Comparison to Predicate Indications: | The subject Baby Gorilla®/Gorilla® Plating System and the predicate systems are intended to be used for stabilization and fixation of fractures, osteotomies, revision procedures, joint fusion, and reconstruction of bones. All indications for the subject device are within the indications of the predicate devices. |
| Comparison to Predicate Technological Characteristics: | The subject Baby Gorilla®/Gorilla® Plating System components possess the same technological characteristics as the predicate devices. 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 | |
| devices. | |
| 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 | |
| predicate marketed devices. Therefore, the Baby | |
| Gorilla®/Gorilla® Plating System is substantially equivalent to | |
| the predicate devices with respect to their indications for use, | |
| technical characteristics, and function. |
3
4
April 12, 2019
Image /page/4/Picture/1 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Paragon 28, Inc. Eric Lintula Director of Regulatory Affairs 4B Inverness Ct. E, STE 280 Englewood, Colorado 80112
Re: K190365
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: March 18, 2019 Received: March 21, 2019
Dear Eric Lintula:
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 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
5
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K190365
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 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, 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
7
| · 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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