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 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.

Device Description

The Baby Gorilla/Gorilla Plating System is comprised of bone plates, threaded bone screws, and washers. 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. 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

The provided text is an FDA 510(k) clearance letter for the Baby Gorilla®/Gorilla® Plating System. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the context of an AI/ML-driven medical device.

Therefore, many of the requested items regarding acceptance criteria, study details, expert involvement, and ground truth are not applicable to this type of document and product (a metallic bone fixation system). This clearance is based on mechanical performance and material equivalence, not diagnostic accuracy or clinical outcomes as would be relevant for an AI/ML device.

Here's a breakdown of the relevant information from the provided document:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The document implies that the acceptance criteria are met if the modified design does not adversely affect the original testing performance and is "substantially equivalent" to the predicate device. Specific quantitative acceptance criteria are not detailed in this clearance letter. Instead, the focus is on demonstrating that the revised device's characteristics are similar enough to an already approved device to not raise new safety or effectiveness concerns.
Reported Device Performance:
- Performance: Shown not to be adversely affected by modifications.
- Basic Design: Similar to the predicate.
- Material: Similar to the predicate (medical grade titanium per ASTM F67, stainless steel per ASTM F138, and titanium alloy per ASTM F136).
- Manufacturing: Similar to the predicate.
- Sizes (dimensions): Comparable to those offered by the predicate systems.

Category	Acceptance Criteria	Reported Device Performance
Overall Equivalence	The modified design and performance are not adversely affected by changes and are substantially equivalent to the predicate device, not raising new questions of safety and effectiveness.	"The results of the analysis demonstrated the modified designs are substantially equivalent to the predicate devices." "Differences between the Baby Gorilla®/Gorilla® Plating System implants and the predicate devices were shown not to raise new questions of safety and effectiveness." "The subject devices possess identical indications for use, materials, design, and principles of operation as the predicates."
Performance	Not explicitly stated as quantitative metrics, but implicitly refers to the original testing performance of the predicate device. The modified device must not be adversely affected relative to this original performance.	"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."
Basic Design	Similar to the predicate device.	"The subject Baby Gorilla®/Gorilla® Plating System components possess similar technological characteristics as the predicate device... basic design."
Material	Similar to the predicate device.	"The subject Baby Gorilla®/Gorilla® Plating System components possess similar technological characteristics as the predicate device... material." Specifically, medical grade titanium (ASTM F67), stainless steel (ASTM F138), and titanium alloy (ASTM F136).
Manufacturing	Similar to the predicate device.	"The subject Baby Gorilla®/Gorilla® Plating System components possess similar technological characteristics as the predicate device... manufacturing."
Sizes (dimensions)	Comparable to those offered by the predicate systems.	"The subject Baby Gorilla®/Gorilla® Plating System components possess similar technological characteristics as the predicate device... sizes (dimensions are comparable to those offered by the predicate systems)."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The clearance is based on engineering analysis and comparison to a predicate device, not a clinical study with a patient test set in the traditional sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. This is a hardware device (bone plating system), not an AI/ML diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided.

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

This information is not applicable and not provided. This device is a bone plating system, not an AI-assisted diagnostic tool.

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

This information is not applicable and not provided. This is a hardware device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's substantial equivalence is its physical and mechanical properties and performance, as determined through engineering analysis and comparison to a legally marketed predicate device (K203511). It's not a clinical "ground truth" derived from patient data or expert consensus.

8. The sample size for the training set

This information is not applicable and not provided. As a physical medical device, there is no "training set" in the context of an AI/ML algorithm.

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

This information is not applicable and not provided.

Summary

FDA 510(k) Clearance Letter - Baby Gorilla®/Gorilla® Plating System

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

July 18, 2025

Paragon 28 Inc
Edward Wells-Spicer
Regulatory Affairs Specialist II
14445 Grasslands Drive
Englewood, Colorado 80112

Re: K250952
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: June 20, 2025
Received: June 20, 2025

Dear Edward Wells-Spicer:

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 (the 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 available 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.

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K250952 - Edward Wells-Spicer
Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

Page 3

K250952 - Edward Wells-Spicer
Page 3

assistance/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,

Thomas Mcnamara -S

For: Christopher Ferreira, M.S.
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

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known): K250952

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 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

Page 5

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)

☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 6

510(K) SUMMARY

Manufacturer: Paragon 28, Inc.
14445 Grasslands Dr.
Englewood, CO 80112

Contact: Edward Wells-Spicer
Regulatory Affairs Specialist II
Paragon 28, Inc.
14445 Grasslands Dr.
Englewood, CO 80112
Phone: 720-994-5481
ewspicer@paragon28.com

Date Prepared: March 28, 2025

Device Trade Names: Baby Gorilla®/Gorilla® Plating System

Device Class: Class II

Primary Predicate(s): Baby Gorilla®/Gorilla® Plating System (K203511)

Device Description: The Baby Gorilla/Gorilla Plating System is comprised of bone plates, threaded bone screws, and washers. 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. 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).

Classification and Product Codes:

Regulation	Description	Product Code
21 CFR 888.3030	Plate, Fixation, Bone	HRS
21 CFR 888.3040	Screw, Fixation, Bone	HWC

K250952
Page 1 of 4

Page 7

Regulation	Description	Product Code
21 CFR 888.3030	Washer, Bolt Nut	HTN

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 fractures (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 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

K250952
Page 2 of 4

Page 8

Indications for Use (continued):

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
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 Lengthing (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.

K250952
Page 3 of 4

Page 9

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 similar 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 Testing:

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.

Conclusions:

The subject device Baby Gorilla/Gorilla Plating System is substantially equivalent to the previously cleared predicate device Baby Gorilla/Gorilla Plating System (K203511).

The subject devices possess identical indications for use, materials, design, and principles of operation as the predicates. The proposed device modifications do not raise new issues of safety or effectiveness. The subject devices are substantially equivalent to the legally marketed, predicate Baby Gorilla/Gorilla Plating System.

K250952
Page 4 of 4

Regulation Number and Section

N/A