(30 days)
Not Found
No
The document describes a system of bone plates and screws for fracture fixation and reconstruction. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is indicated for stabilizing fractures, fusing joints, and reconstructing bones, which are therapeutic interventions.
No
The device is described as an implantable system for stabilizing fractures and performing reconstructive procedures, not for diagnosing conditions.
No
The device description explicitly states it consists of "Bone Plates and Bone Screws" and "implants," which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "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". This describes a surgical implant used in vivo (within the body) for structural support and repair.
- Device Description: The description details "lower extremity fixation systems" consisting of "plates" and "screws". These are physical implants designed to be surgically placed.
- 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 treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
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 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. The system can be used atric patients.
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® implants are lower extremity 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
small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus.
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 subsequence performance is not adversely affected by the geometry of the modified plates, screws, and washers.
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)
K140397, K172886, K121425, K141735
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the acronym "FDA" followed by the words "U.S. Food & Drug Administration".
September 9, 2018
Paragon 28, Inc. Eric Lintula Director of Regulatory Affairs 4B Inverness Ct. E. STE 280 Englewood, Colorado 80112
Re: K182148
Trade/Device Name: SILVERBACK 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: August 2, 2018 Received: August 8, 2018
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 medical devices and radiation-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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K182148
Device Name SILVERBACK Gorilla Plating System
Indications for Use (Describe)
The BABY GORILLA®/GORILLA® Bone Plates and Bone Screws of the BABY GORILLA®/GORILLA® Plating System are indicated for use in stabilization of fractures or osteotomies; intra and extra articular fractures, 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. The system can be used atric patients.
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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Date: | August 2nd, 2018 |
|---|---|
| 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 |
| Senior Director of Quality and Regulatory Affairs | |
| Trade Names: | SILVERBACK Gorilla Plating System |
| Regulatory Class: | Class II |
| Regulation, Product | |
| Code, Classification, and | |
| Common Name: | 888.3030, HRS, Single/multiple component metallic |
| bone fixation appliances and accessories, bone plate | |
| system | |
| 888.3040, HWC, Smooth or threaded metallic bone | |
| fixation fastener, bone screw | |
| 888.3030, HTN, Single/multiple component metallic | |
| bone fixation accessories, washer | |
| Device Description: | The BABY GORILLA®/GORILLA® implants are lower |
| extremity 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. | |
| Materials: | The BABY GORILLA®/GORILLA® implants are |
| manufactured from medical grade titanium (per ASTM | |
| F67), stainless steel (per ASTM F138), and titanium | |
| alloy (per ASTM F136). | |
| 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. The | |
| system can be used in both adult and pediatric patients. | |
| 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. | |
| Primary Predicate: | K140397, BABY GORILLA®/GORILLA® Plating |
| System (formerly ParaLock Plating System), Paragon | |
| 28, Inc. | |
| Additional Predicates: | K172886, BABY GORILLA®/GORILLA® Breakaway |
| Screw System, Paragon 28, Inc. | |
| K121425, ORTHOLOCTM 3Di Ankle Fusion System, | |
| Wright Medical Technology, Inc. | |
| K141735, Ankle Fusion Plating System, Arthrex, Inc. | |
| Performance Data: | Engineering analysis is presented to provide evidence |
| that the original testing and subsequence performance is | |
| not adversely affected by the geometry of the modified | |
| plates, screws, and washers. |
The results of the analysis demonstrated the modified
designs are substantially equivalent to the predicate
devices. |
| Technological
Characteristics: | The modified Gorilla plates, screws, and washers 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). Therefore, the fundamental scientific technology of the
modified Gorilla Plates, Screws, and Washers is similar
to previously cleared devices. |
| Conclusion: | The modified Gorilla Plates, Screws, and Washers
possess indications for use and technological
characteristics that are the same as the predicate devices.
Therefore, the modified Gorilla Plates, Screws, and |
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