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.

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).

AI/ML Overview

This FDA 510(k) Premarket Notification document describes a medical device, the Baby Gorilla®/Gorilla® Plating System, which is a system for internal fixation of bones. The application is for substantial equivalence to a previously cleared device, not for a novel AI or diagnostic device. Therefore, many of the requested elements for an AI/diagnostic device study (like MRMC studies, effect size of AI assistance, specific ground truth methods for algorithm training, and detailed expert qualifications) are not applicable to this type of submission.

However, I can extract the relevant information regarding acceptance criteria and performance data as presented in the document for a medical device seeking substantial equivalence.

Acceptance Criteria and Reported Device Performance

The core of a 510(k) submission for substantial equivalence is demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is primarily achieved by showing that the new device has the same (or substantially similar) indications for use and technological characteristics, and that any differences do not raise new questions of safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria (Implicitly based on predicate)	Reported Device Performance (Subject Device)
Indications for Use	Identical to the predicate device.	Identical to the predicate device (Baby Gorilla®/Gorilla® Plating System, K190365).
Technological Characteristics	- Performance- Basic Design- Material- Manufacturing- Sizes (dimensions are comparable)	Same technological characteristics as the predicate:- Performance- Basic design- Material (medical grade titanium, stainless steel, titanium alloy)- Manufacturing- Sizes (dimensions are comparable to those offered by predicate systems).
Safety and Effectiveness	Differences do not raise new questions of safety and effectiveness.	Differences between the subject and predicate devices were shown not to raise new questions of safety and effectiveness through engineering analysis.

2. Sample size used for the test set and the data provenance:

Not applicable (N/A) in the context of an AI/diagnostic device study. This submission is for a bone plating system, not a diagnostic algorithm. The "test set" here refers to the device itself and its components.
Data Provenance: The performance data is derived from "engineering analysis." This typically involves laboratory testing of materials and designs, not clinical data from patients in a specific country.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

N/A. This information pertains to establishing ground truth for diagnostic or AI algorithm performance. For a bone plating system, the "ground truth" is adherence to established material properties, mechanical strength requirements, and manufacturing standards. This is evaluated by engineers and regulatory bodies against recognized standards, not by clinical experts establishing diagnostic ground truth.

4. Adjudication method for the test set:

N/A. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers in diagnostic studies. This is not relevant for the engineering analysis of a bone plating system.

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:

N/A. This is a device for internal fixation, not an AI or diagnostic tool. No human readers or AI assistance are involved in its primary function.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

N/A. This is not an algorithm. The device is a physical bone plating system.

7. The type of ground truth used:

For this type of medical device (bone plating system), the "ground truth" is primarily based on engineering standards, material specifications (e.g., ASTM F67 for medical grade titanium, ASTM F136 for titanium alloy, ASTM F138 for stainless steel), and mechanical performance requirements. The performance data section states, "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." This means the device's mechanical properties, biocompatibility, and intended function are assessed against established benchmarks and industry standards for similar devices. There is no "pathology" or "outcomes data" in the sense of a clinical trial used here to establish ground truth for a diagnostic context.

8. The sample size for the training set:

N/A. This device is not an AI algorithm, so there is no "training set."

9. How the ground truth for the training set was established:

N/A. As there is no training set for an AI algorithm, this question is not applicable.

Summary

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December 29, 2020

Image /page/0/Picture/1 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Paragon 28, Inc. Haylie Hertz Regulatory Affairs Specialist 14445 Grasslands Dr. Englewood, Colorado 80112

Re: K203511

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: November 25, 2020 Received: November 30, 2020

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, MPH 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K203511

Device Name Baby Gorilla®/Gorilla® Plating System

Indications for Use (Describe)

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)

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.

Attachment E

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510(k) Summary

Device Trade Name:	Baby Gorilla®/Gorilla® Plating System
Manufacturer:	Paragon 28, Inc.14445 Grasslands Dr.Englewood, CO 80112
Contact:	Ms. Haylie HertzRegulatory Affairs SpecialistPhone: 303.720.0017hhertz@paragon28.com
Date Prepared:	November 25, 2020
Classification:	21 CFR §888.3030, Plate, Fixation, Bone21 CFR §888.3040, Screw, Fixation, Bone21 CFR §888.3030, Washer, Bolt Nut
Class:	II
Product Code:	HRS, HWC, HTN
Common Name:	Bone Plate, Bone Screw, Bone Washer
Predicate Device:	Baby Gorilla®/Gorilla® Plating System (K190365)

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, 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 ●

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Talo-Navicular (TN) Fusion ●
Calcaneo-Cuboid (CC) Fusion ●
Subtalar Fusion
Medial Column Fusion 0
o Cuneiform Fracture
Cuboid Fracture
Navicular Fracture o

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
o Pilon Fractures
Distal Tibia Shaft Fractures ●
o 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 ●
o 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)
0 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)
0 Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)
o Calcaneal Slide Osteotomy

Charcot:

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. 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:

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). o

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 Plating System (K190365).

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Therefore, the Baby Gorilla®/Gorilla® Plating System is substantially equivalent to the predicate device with respect to indications for use, technical characteristics, and function.

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.