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 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 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 "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.

AI/ML Overview

Here's an analysis of the provided text regarding the Baby Gorilla®/Gorilla® Plating System, focusing on the acceptance criteria and study information:

This document is a 510(k) Summary for a medical device (K190365), seeking clearance for substantial equivalence to previously marketed devices. In these types of submissions for orthopedic implants, the "acceptance criteria" are not clinical performance outcomes like sensitivity/specificity but rather engineering and material testing standards. The "study" refers to the engineering analyses and tests conducted to demonstrate that the modified device meets the performance characteristics of its predicates.

Based on the provided text, a table of acceptance criteria and reported device performance, and details about studies are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Performance (mechanical properties, strength, fatigue resistance)	"The results of the analysis demonstrated the modified designs are substantially equivalent to the predicate devices." (Implies that the modified designs meet or exceed the performance of the predicate devices in relevant engineering tests, adhering to established standards for bone fixation implants.)
Basic Design (geometric configuration, screw-plate interface)	"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)." (Implies the design features are comparable and do not introduce new risks, meeting design standards of similar, cleared devices.)
Material (biocompatibility, mechanical properties)	"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)." (Compliance with recognized ASTM standards for medical grade materials serves as the acceptance criteria for material properties and biocompatibility. The reported performance is that the materials meet these specified standards.)
Manufacturing (process controls, quality, sterilization compatibility)	"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..." (Implies manufacturing processes are similar to those for predicate devices and meet established quality and safety standards, ensuring the final product meets its specified characteristics.)
Sizes (dimensions, fit with screws/washers)	"...and sizes (dimensions are comparable to those offered by the predicate systems)." (Implies that the dimensions and sizing match the acceptance criteria established by the predicate devices, ensuring compatibility and appropriate fit for the indicated uses. The reported performance is that the dimensions are comparable to predicate devices, thus meeting the functional requirements for surgical application.)

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: Not explicitly stated as this is not a clinical study with patients. For engineering analysis, the "sample size" would refer to the number of physical samples tested or the scope of the computational models used. This information is typically detailed in the full test reports, which are not included in this summary.
Data Provenance: The data comes from engineering analyses and testing conducted by the manufacturer, Paragon 28, Inc. It is not patient or clinical data, so terms like "country of origin" or "retrospective/prospective" are not applicable in the usual sense for clinical studies. It is internal company data, likely from laboratory testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information is not applicable to this submission. "Ground truth" established by experts (e.g., radiologists) is relevant for AI/imaging device clearances where clinical accuracy is being assessed. For a 510(k) for an orthopedic implant like the Baby Gorilla®/Gorilla® Plating System, the "ground truth" is based on established engineering principles, material science, and the functional performance of the device against recognized standards and predicate devices. No external expert panel is typically used for this type of "ground truth" establishment in engineering testing for substantial equivalence.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert interpretations in clinical studies, particularly for diagnostic accuracy. Since this submission relies on engineering analysis and comparison to predicate devices rather than clinical interpretation of data, an adjudication method is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

No. An MRMC study is relevant for AI-powered diagnostic devices. This submission pertains to an orthopedic implant, which is a physical device used in surgery, not a diagnostic tool where human readers assess images. Therefore, no MRMC study was conducted, and the concept of "human readers improving with AI assistance" does not apply.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical implant, not an algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this 510(k) submission.

7. The Type of Ground Truth Used

The "ground truth" for this medical device's claims of safety and effectiveness, for the purpose of a 510(k), is based on:
- Engineering Standards: Compliance with recognized ASTM standards for materials (e.g., ASTM F67, F138, F136).
- Mechanical Testing Results: Data from physical tests (e.g., fatigue, static strength, push-out/pull-out forces) that demonstrate the device's mechanical performance is equivalent to or better than predicate devices and suitable for its intended anatomical use.
- Comparison to Predicate Devices: The foundational "ground truth" for a 510(k) is the established safety and effectiveness of the legally marketed predicate devices. The new device must demonstrate it is "substantially equivalent" to these predicates in terms of intended use, technological characteristics, and performance.

8. The Sample Size for the Training Set

Not applicable. A "training set" refers to data used to train machine learning models. This device is an orthopedic implant, not an AI/ML product. Therefore, no training set was involved.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As no training set was involved, this question is not relevant.

Summary

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510(k) Summary

Date:	March 18th, 2019
510(k) Number:	K190365
Sponsor:	Paragon 28, Inc.4B Inverness Ct. E., STE 280Englewood, Colorado 80112Phone: (888) 728-1888Fax: (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 CommonName:	888.3030, HRS, Plate, Fixation, Bone888.3040, HWC, Screw, Fixation, Bone888.3030, HTN, Washer, Nut Bolt
DeviceDescription:	The Baby Gorilla®/Gorilla® Plating System implants are internalfixation systems. Gorilla® Plates are offered in “mini” and"standard" set sizes in a variety of shapes based upon theanatomical fixation required. Screws are also offered in "mini"and "standard" sets and, in addition, in locking and non-lockingversions. Size-matched washers are available for use with thenon-locking screws when the latter are used for fixation withoutthe plates. Size-matched plate washers are also available for usewith plate holes when there is no desire to use a screw.
CompatibleDevices:	K124027, K151418, K153378 Monster® Screw System
Indications forUse:	The Baby Gorilla®/Gorilla® Bone Plates and Bone Screws of theBaby Gorilla®/Gorilla® Plating System are indicated for use instabilization and fixation of fractures or osteotomies; intra andextra articular fractures, joint depression, and multi-fragmentaryfractures; revision procedures, joint fusion and reconstruction ofsmall bones of the toes, feet and ankles including the distal tibia,talus, and calcaneus, as well as the fingers, hands, and wrists. Thesystem can be used in both adult and pediatric patients. Specificexamples 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:

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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 ●

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	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 cleareddevices.
PerformanceData:	Engineering analysis is presented to provide evidence that theoriginal testing and subsequent performance is not adverselyaffected by the modifications to the subject devices.The results of the analysis demonstrated the modified designs aresubstantially equivalent to the predicate devices.
Conclusion:	The modified Baby Gorilla®/Gorilla® Plating System possessedthe same indications for use and technological characteristics aspredicate marketed devices. Therefore, the BabyGorilla®/Gorilla® Plating System is substantially equivalent tothe predicate devices with respect to their indications for use,technical characteristics, and function.

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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

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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

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· 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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Regulation Number and Section

§ 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.