The Forma Medical Optimal Plating System is intended for fixation of fractures, osteotomies, arthrodeses, and bone reconstructions in adult patients with normal or osteopenic bone. Indications include flat (scapula), long (clavicle, upper and lower extremities including metacarpals, and phalanges), irregular (pelvis, hand, foot) bones and joints (wrist, ankle). The Forma Medical Optimal Plating System is not indicated for ribs, sternum, spine, or the skull.

Device Description

The Forma Medical Optimal Plating System is designed to hold bones in relative stability for fracture fixation and arthrodesis. The plates and screws are available in multiple sizes based on patient anatomy and clinical application. The screws are manufactured from titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F67, F136, F1537, and F138. The plates are manufactured from titanium, titanium alloy, or stainless steel, as specified in ASTM F67, F136, and F138. The system includes plates, screws and instruments. The system instrumentation is manufactured from stainless steel, aluminum, and other surgical grade materials.

AI/ML Overview

The provided text describes mechanical testing performed to demonstrate substantial equivalence for the Forma Medical Optimal Plating System. It does not contain information about an AI/ML-enabled device or a study involving human readers. Therefore, many of the requested fields are not applicable.

Here's the relevant information:

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

Acceptance Criterion (Test)	Reported Device Performance
Screw: Torsional Strength per ASTM F543-23	Mechanical testing results demonstrated substantial equivalence to predicate system screws.
Screw: Insertion/Removal Torque per ASTM F543-23	Mechanical testing results demonstrated substantial equivalence to predicate system screws.
Screw: Pullout Strength	Mechanical testing results demonstrated substantial equivalence per the Chapman analytical formula.
Plate: Four-Point Bending per ASTM F382-17	Mechanical testing results demonstrated substantial equivalence to predicate system plates.

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

The document does not explicitly state the sample size (number of screws or plates) used for each mechanical test. Data provenance (country of origin, retrospective/prospective) is not applicable for mechanical testing of a physical device.

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)

Not applicable. Ground truth for mechanical testing is established by engineering standards and measurement, not expert consensus.

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

Not applicable. Adjudication methods are relevant for subjective assessments, not for objective mechanical testing.

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

Not applicable. This device is a physical bone fixation system, not an AI-enabled diagnostic tool.

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

Not applicable. This device is a physical bone fixation system, not an AI-enabled diagnostic tool.

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

The ground truth for the mechanical testing is based on established engineering standards (ASTM F543-23, ASTM F382-17) and an analytical formula (Chapman analytical formula for pullout strength).

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable. This is a physical device, not an AI model.

Summary

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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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

June 26, 2024

Forma Medical, Inc. % Jennifer Palinchik President JALEX Medical, LLC 27865 Clemens Rd., Suite 3 Westlake, Ohio 44145

Re: K234059

Trade/Device Name: Forma Medical Optimal 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 Dated: June 21, 2024 Received: June 21, 2024

Dear Jennifer Palinchik:

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.

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"

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K234059 - Jennifer Palinchik

(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 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-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 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.

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-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 -S

Shumaya Ali, M.P.H. 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

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Indications for Use

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

Submission Number (if known)

K234059

Device Name

Forma Medical Optimal Plating System

Indications for Use (Describe)

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.

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Image /page/3/Picture/0 description: The image shows the logo for Forma Medical. The logo consists of a geometric design on the left and the words "FORMA MEDICAL" on the right. The geometric design is made up of three overlapping triangles, with the outer triangle in teal and the inner triangles in gray. The word "FORMA" is in gray, and the word "MEDICAL" is in teal.

510(k) Summary

Submitted By:	Forma Medical, Inc.3401 Hartzdale DriveSuite 103B, Unit #611Camp Hill, PA 17011
Date:	06/21/2024
Contact Person:	Jennifer Palinchik, President, JALEX Medical
Contact Telephone:	(440) 935-3282
Contact Fax:	(440) 933-7839
Device Trade Name:	Forma Medical Optimal Plating System
Common Name:	Plate, Fixation, BoneScrew, Fixation, Bone
Device Classification Name:	Single/multiple component metallic bone fixation appliances andaccessoriesSmooth or threaded metallic bone fixation fastener
Device Classification:	Class II
Reviewing Panel:	Orthopedic
Product Code:	HRS, HWC
Primary Predicate Device:	Globus Medical ANTHEM® Fracture System (K180554)
Reference Device:	Nova Step Airlock® (K151277, K143523)APTUS Foot System (K142581)

Device Description:

Indications for Use:

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Image /page/4/Picture/0 description: The image shows the logo for Forma Medical. The logo consists of a geometric shape on the left and the words "FORMA MEDICAL" on the right. The geometric shape is made up of three overlapping triangles, with the outer triangles in teal and the inner triangles in gray. The word "FORMA" is in gray, and the word "MEDICAL" is in teal.

Summary of Technological Characteristics:

The Forma Optimal Plating System and the predicates have intended use and fundamental scientific technology. All devices compare similarly in:

· Design features
Intended use .
Materials .
Dimensions .
Function .

Item	Forma Medical OptimalPlating System	Globus MedicalANTHEM® Fracture System(K180554)	Nova StepAirlock®(K151277, K143523)	APTUS Foot System(K142581)	Comparison
ClassificationName	Single/multiple componentmetallic bone fixationappliance and accessoriesSmooth or threaded metallicbone fixation fastener	Single/multiple componentmetallic bone fixation applianceand accessoriesSmooth or threaded metallicbone fixation fastener	Single/multiplecomponent metallic bonefixation appliance andaccessories	Single/multiple componentmetallic bone fixationappliance and accessories	Equivalent
Regulation	888.3030, 888.3040	888.3030, 888.3040	888.3030	888.3030	Equivalent
Product Code	HRS, HWC	HRS, HWC	HRS	HRS, HWC	Equivalent
Indicationsfor Use	The Forma Medical OptimalPlating System is intendedfor fixation of fractures,osteotomies, arthrodeses, andbone reconstructions in adultpatients with normal orosteopenic bone. Indicationsinclude flat (scapula), long(clavicle, upper and lowerextremities includingmetacarpals, metatarsals, andphalanges), irregular (pelvis,hand, foot) bones and joints(wrist, ankle). The FormaMedical Optimal PlatingSystem is not indicated for	The ANTHEM® FractureSystem is indicated for fixationof fractures, osteotomies,arthrodesis and reconstructionof bones for the appropriate sizeof the device to be used in adultpatients, including the clavicle,scapula, humerus, radius, ulna,small bones (metacarpals,metatarsals, phalanges), wrist,pelvis, femur, tibia, fibula,ankle, and foot.The clavicle hook plate may beused for dislocations of theacromioclavicular joint. Minifragment plates are also	The Airlock®osteosynthesis platesystems are indicated forstabilization and fixationof fresh fractures,revision procedures, jointfusions andreconstruction of smallbones of the hands, feet,wrists and ankles, fingersand toes. The systemmay be used in both adultand pediatric patients.	The APTUS® Foot System isintended for use in smallbones, in particular infractures, osteotomies andarthrodesis of the tarsals,metatarsals and phalanges.	Equivalent toprimarypredicate
	ribs, sternum, spine, or theskull.	indicated for fixation offractures of the acetabulum,patella, and bone fragments,replantation, malunions andnonunions, and for non-loadbearing stabilization andreduction of long bonefragments.Small fragment, mini fragment,proximal tibia, clavicle anddistal fibula plates may be usedin all pediatric subgroups(except neonates) and smallstature adults. Distal radius andmini fragment plates may beused in adolescents (12-21years of age).Plating may be used in patientswith osteopenic bone.
Description	The Forma Optimal PlatingSystem comprises a range ofplates and screws created forinternal bone fixation. Theseimplants come in a range ofsizes and shapes to suitindividual patient anatomyand can be either contouredor straight, featuring bothlocking and non-lockingscrews. Optimal implants arecrafted from materialsincluding titanium, titaniumalloy, cobalt chromiummolybdenum alloy, orstainless steel, as outlined inASTM standards F67, F136,F1295, F1472, F1537,F2229, F138, and F139. Allimplants are designed forsingle-use only.	The ANTHEM® FractureSystem is a family of plates andscrews designed to be used forinternal bone fixation. Theimplants are available invarious sizes and shapes toaccommodate patient anatomy,and may be contoured orstraight, with locking and non-locking screws. ANTHEM®implants are manufactured fromtitanium, titanium alloy, cobaltchromium molybdenum alloy,or stainless steel, as specified inASTM F67, F136, F1295,F1472, F1537, F2229, F138 andF139. All implants are forsingle use only.	Airlock® osteosynthesisplate systems are aresingle-use bone fixationdevices intended to bepermanently implanted.Plates are designed withdifferent shapes and aremade of Titanium (AlloyTi-6Al-4V ELI).The system uses either3mm or 3,5mm lockingand non-locking screws.The drill hole are alignedto make sure there-is norisk of conflict betweenthe screws.The plates varyessentially throughdifferent curvatures,lengths, number of holesand shape.	The subject device plates areprovided in a variety ofanatomical designs, invarious lengths, widths andthicknesses. The platethickness varies from 1.6 mmto 2.0 mm depending on thedesign. The screw holes ofthe subject device plates aredesigned to accommodateappropriately sized subjectdevice screws, or screwspresently marketed as part ofthe APTUS System andpreviously cleared underK091479. The subject deviceplates also are compatiblewith K-wires cleared underK092038. The subject deviceplates are used with TriLocklocking screws and cortical	Equivalent toprimarypredicate
					(nonlocking) screws. Allsubject device screws areself-tapping and self-drillingand provided in diameters of2.0, 2.8 and 3.5 mm, and invarious lengths from 8 to 45mm.The subject device plates aremade of commercially puretitanium, Grade 4,conforming to ASTM F67Standard Specification forUnalloyed Titanium forSurgical ImplantApplications (UNS R50250,UNS R50400, UNS R50550,UNS R50700). The subjectdevice screws are made oftitanium alloy conforming toASTM F136 StandardSpecification for WroughtTitanium-6 Aluminum-4Vanadium ELI (Extra LowInterstitial) Alloy forSurgical ImplantApplications (UNS R56401).
Material	Titanium Alloy,Cobalt ChromiumMolybdenum Alloy, andStainless steel per ASTMF67, F136, F1295, F1472,F1537, F2229, F138 andF139.	Titanium Alloy,Cobalt Chromium MolybdenumAlloy, andStainless steel per ASTM F67,F136, F1295, F1472, F1537,F2229, F138 and F139.	Titanium (Alloy Ti-6Al-4V ELI).	Titanium Alloy per ASTMF67, ASTM F136	Equivalent toprimarypredicate
Plate Styles	Straight, Contourable, andpre-shaped	Straight, Contourable, and pre-shaped	Straight, Contourable,and pre-shaped	Straight, Contourable, andpre-shaped	Equivalent toprimarypredicate
Plate Lengths	23 to 153mm	21mm to 155mm	22.5mm to 53mm	16 to 76 mm	Equivalent
Screw Styles	Locking and Non-locking	Locking and Non-locking	Locking and Non-locking	Locking and Non-locking	Equivalent
ScrewLengths	6mm to 85mm	6mm to 85mm	N/A	8 to 45 mm	Equivalent

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Image /page/5/Picture/0 description: The image shows the logo for Forma Medical. The logo consists of a geometric symbol on the left and the words "FORMA MEDICAL" on the right. The geometric symbol is made up of three triangles that are intertwined. The word "FORMA" is in dark gray, and the word "MEDICAL" is in teal.

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Image /page/6/Picture/0 description: The image shows the logo for Forma Medical. The logo consists of a geometric design on the left and the words "FORMA MEDICAL" on the right. The geometric design is made up of three overlapping triangles, with the outer triangles in teal and the inner triangle in gray. The word "FORMA" is in gray and the word "MEDICAL" is in teal.

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Image /page/7/Picture/0 description: The image shows the logo for Forma Medical. The logo consists of a stylized teal-colored symbol resembling three interconnected triangles on the left. To the right of the symbol is the text "FORMA" in bold, dark gray letters above the word "MEDICAL" in teal.

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Image /page/8/Picture/0 description: The image shows the logo for Forma Medical. On the left is a teal triangle design with three triangles stacked on top of each other. The word "FORMA" is in dark gray, and the word "MEDICAL" is in teal.

Mechanical Testing:

Substantial equivalence is supported by mechanical evaluation to confirm features, geometry, and performance of the subject devices compared to the predicate devices in torsional strength and insertion/removal torque per ASTM F543, and pullout strength per the Chapman analytical formula, as well as four-point bending per ASTM F382.

	Subject Device
	Forma Medical Optimal Plating System
Screw: Torsional Strength perASTM F543-23	Mechanical testing results demonstrated substantial equivalence to predicatesystem screws
Screw: Insertion/RemovalTorque per ASTM F543-23	Mechanical testing results demonstrated substantial equivalence to predicatesystem screws
Screw: Pullout Strength	Mechanical testing results demonstrated substantial equivalence per theChapman analytical formula
Plate: Four-Point Bending perASTM F382-17	Mechanical testing results demonstrated substantial equivalence to predicatesystem plates

Conclusion:

Based on the indications for use, technological characteristics, and mechanical testing comparison with the predicate devices, the subject device has demonstrated substantial equivalence.

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.