Forma Medical Headless Compression Screws are indicated for fixation of intra-articular and extra articular fractures, avulsions, non-unions, and osteotomies of small bone fragments; as well as arthrodesis of small joints.

Device Description

Forma Medical Headless Compression Screws are designed to hold bones in relative stability for fracture fixation and arthrodesis. The screws are available in multiple diameters and lengths 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 F136, F1537, and F138. The system includes screws and instruments. The system instrumentation is manufactured from stainless steel, aluminum, and other surgical grade materials.

AI/ML Overview

The provided text is a 510(k) summary for the Forma Medical Headless Compression Screw. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

It does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of clinical performance, specifically regarding AI/ML device performance or human reader improvement.

The document solely focuses on demonstrating substantial equivalence based on technological characteristics and mechanical performance compared to predicate devices. It mentions mechanical testing per ASTM F543 for torsional strength, insertion/removal torque, and pullout strength. However, it does not provide specific acceptance criteria values or detailed results of these tests.

Therefore, it is not possible to answer the user's request based on the provided text. The request asks for details about acceptance criteria and a study proving "the device meets the acceptance criteria," implying a performance study, likely clinical, which is entirely absent from this 510(k) summary for a mechanical orthopedic implant.

To reiterate, the document details:

Device name and indications for use.
Comparison of technological characteristics (classification, regulation, product code, indications for use, description, material, lengths, cannulation) between the Forma Medical screw and several predicate devices.
Mention of mechanical testing (torsional strength, insertion/removal torque, pullout strength per ASTM F543) to support substantial equivalence.

It does not contain information regarding:

A table of acceptance criteria with reported device performance values.
Sample sizes for a test set or data provenance.
Number of experts or their qualifications for ground truth establishment.
Adjudication methods.
MRMC comparative effectiveness studies or effect sizes for human reader improvement with AI.
Standalone algorithm performance.
Types of ground truth (expert consensus, pathology, outcomes data).
Training set sample size.
How ground truth for the training set was established.

These specific points are relevant to AI/ML software as a medical device (SaMD) clearances, not directly to a mechanical orthopedic implant like a compression screw where the focus is on mechanical and material equivalence.

Summary

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July 18, 2023

Forma Medical, Inc. % Kvle Kovach Sr. Quality and Regulatory Engineer JALEX Medical 27865 Clemens Rd Suite 3 Westlake, Ohio 44145

Re: K230945

Trade/Device Name: Forma Medical Headless Compression Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: June 16, 2023 Received: June 16, 2023

Dear Kyle Kovach:

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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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.

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For

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of 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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Indications for Use

510(k) Number (if known) K230945

Device Name Forma Medical Headless Compression Screw

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)

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Image /page/3/Picture/1 description: The image contains the logo for Forma Medical. On the left side of the logo, there are three triangles that are intertwined. The text "FORMA MEDICAL" is on the right side of the logo, with "FORMA" in a dark gray color and "MEDICAL" in a light blue color.

510(k) Summary

Submitted By:	Forma Medical, Inc.3401 Hartzdale DriveSuite 103B, Unit #611Camp Hill, PA 17011
Date:	07/11/2023
Contact Person:Contact Telephone:Contact Fax:	Kyle Kovach, Sr. Quality and Regulatory Engineer, JALEX Medical(440) 787-5832(440) 933-7839
Device Trade Name:Common Name:Device Classification Name:Device Classification:Reviewing Panel:Product Code:Primary Predicate Device:Reference Devices:	Forma Medical Headless Compression ScrewScrew, Fixation, BoneSmooth or threaded metallic bone fixation fastener (21 CFR 888.3040)Class IIOrthopedicHWCSynthes (USA) 1.5mm Headless Compression Screws (K090949)Globus Medical CAPTIVATETM Compression Screws (K162825)OsteoMed ExtremiFix Mini & Small Cannulated Screw System(K202680)

Device Description:

Indications for Use:

Summary of Technological Characteristics:

The Forma Medical Headless Compression Screw and the predicates have the same intended use and fundamental scientific technology. All devices compare similarly in:

Design features
Intended use
Materials
Dimensions ●
Function

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Image /page/4/Picture/1 description: The image shows the logo for Forma Medical. On the left is a teal triangle outline with two smaller triangles inside of it. The word "FORMA" is in dark gray, and the word "MEDICAL" is in teal.

Technological Characteristics Comparison

Item	Forma MedicalHeadlessCompressionScrew	Synthes (USA)1.5mm HeadlessCompressionScrews(K090949)	Globus MedicalCAPTIVATE™CompressionScrews(K162825)	OsteoMedExtremiFix Mini& SmallCannulatedScrew System(K202680)	Comparison
ClassificationName	Smooth orthreaded metallicbone fixationfastener	Smooth orthreaded metallicbone fixationfastener	Smooth orthreaded metallicbone fixationfastener	Smooth orthreaded metallicbone fixationfastener	Equivalent
Regulation	888.3040	888.3040	888.3040	888.3040	Equivalent
Product Code	HWC	HWC	HWC	HWC, HTN	Equivalent
Indicationsfor Use	Forma MedicalHeadlessCompressionScrews areindicated forfixation of intra-articular and extraarticular fractures,avulsions, non-unions, andosteotomies ofsmall bones andsmall bonefragments; as wellas arthrodesis ofsmall joints.	Synthes 1.5mmHeadlessCompressionScrews areindicated forfixation of intra-articular andextra-articularfractures,avulsions, non-unions, andosteotomies ofsmall bones andsmall bonefragments; as wellas arthrodesis ofsmall joints.	CAPTIVATE™CompressionScrews areindicated for usein adult andpediatric patients,for fracture repairand fixation,osteotomy, jointfusion,reconstructionand arthrodesis ofbones appropriatefor the size of thedevice.CAPTIVATE™VL CompressionScrews areindicated for usein adult andpediatric patients,for fracture repairand fixation,osteotomy, jointfusion,reconstructionand arthrodesis ofthe phalanges,metacarpals,carpals,metatarsals,midfoot, hindfoot, ankle, fibula,distal tibia,proximal tibia,radius, ulna,humerus, andclavicle.	The OsteomedExtremiFix Mini& SmallCannulated ScrewSystem isindicated for usein bonereconstruction,osteotomy,arthrodesis, jointfusion, fracturerepair, andfracture fixationof bonesappropriate forthe size of thedevice. Screwsare intended forsingle use only.	Equivalentto primarypredicate
Description	Forma MedicalHeadlessCompression	The Synthes1.5mm HeadlessCompression	CAPTIVATE™Compression	The OsteoMedMini & SmallCannulated Screw	SubstantiallyEquivalent
	Screws aredesigned to holdbones in relativestability forfracture fixationand arthrodesis.The screws areavailable inmultiplediameters andlengths based onpatient anatomyand clinicalapplication. Thescrews aremanufacturedfrom titaniumalloy, cobaltchromiummolybdenumalloy, or stainlesssteel, as specifiedin ASTM F136,F1537, and F138.The systemincludes screwsand instruments.The systeminstrumentation ismanufacturedfrom stainlesssteel, aluminum,and other surgicalgrade materials.	Screws are solidbone fixationscrews featuring apartially threadedshaft and threadedhead. The screwsare available instainless steel andtitanium.	bone screwsdesigned tocompactjuxtaposed bonefor reconstructionand enhancedarthrodesis. Theimplants areavailable invarious diametersand lengths toaccommodatepatient anatomy,with headless,partially or fullythreaded, solid orcannulated, andvariable length(VL) options.CAPTIVATE™implants aremanufacturedfrom titaniumalloy, cobaltchromiummolybdenumalloy, or stainlesssteel, as specifiedin ASTM F136,F1295, F1472,F1537 and F138.	System iscomprised ofscrews andwashers used forbone fixation ofthe hand and footfollowing traumaor osteotomy. TheSystem featurescannulated screwsin the followingdimensions:2.0mm screwdiameter- 6mm to42mm screwlength;2.4mm screwdiameter- 6mm to50mm screwlength;3.0mm screwdiameter- 10mmto 40mm screwlength;4.0mm screwdiameter- 12mmto 52mm screwlength;The systeminstrumentsinclude depthgauges,screwdrivers,countersinks,guide wires, andother instrumentsto facilitate theplacement ofscrews.The implants(screws andwashers) of theOsteoMed Mini& SmallCannulated ScrewSystem are madefrom titaniumalloy (ASTMF136).	Equivalentto Globusreferencepredicate
Material	Titanium Alloy,Cobalt ChromiumMolybdenumAlloy, and	Titanium alloy,stainless steel	Titanium Alloy,Cobalt ChromiumMolybdenumAlloy, and	Titanium alloyper ASTM F136
	Stainless steel perASTM F136,F1537, and F138	Stainless steel perASTM F136,F1295, F1472,F1537, and F138
Lengths	Ø1.5 mm: 9-20 mmØ2.0 mm: 10-42 mmØ2.5 mm: 10-50 mmØ3.0 mm: 12-40 mmØ4.0 mm: 14-52 mm	Ø2.5 mm: 9-40 mmØ3.0 mm: 10-40 mmØ4.0 mm: 16-60 mm	Ø2.0 mm: 6-42 mmØ2.5 mm: 6-50 mmØ3.0 mm: 10-40 mmØ4.0 mm: 12-52 mm	Ø1.5 mm equivalent to primary predicateand Ø2.0-4.0 mm equivalent to OsteoMed reference predicate
	Cannulation	Ø1.5 mm: SolidØ2.0-4.0 mm: Cannulated	Solid	Solid and cannulated	Cannulated	Ø1.5 mm equivalent to primary predicateand Ø2.0-4.0 mm equivalent to OsteoMed reference predicate

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Image /page/5/Picture/1 description: The image contains 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 triangle in teal and the inner triangles in gray. The word "FORMA" is in gray, and the word "MEDICAL" is in teal.

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Image /page/6/Picture/1 description: The image contains the logo for Forma Medical. The logo consists of a teal-colored geometric shape on the left, resembling three interconnected triangles. To the right of the shape is the text "FORMA" in a dark gray, blocky font, with "MEDICAL" underneath in a smaller, teal font. The overall design is clean and modern.

Mechanical Testing:

Substantial equivalence is supported by mechanical evaluation and testing compared to the predicate devices in torsional strength, insertion/removal torque, and pullout strength per ASTM F543.

Conclusion:

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

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.