ChM 4.5mm Cortical screws

K210490 · Chm Sp. Z O.O. · HWC · Oct 5, 2021 · Orthopedic

Device Facts

• Record ID: K210490
• Device Name: ChM 4.5mm Cortical screws
• Applicant: Chm Sp. Z O.O.
• Product Code: HWC · Orthopedic
• Decision Date: Oct 5, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The ChM 4.5mm Cortical screws are intended for fixation of various long bones, such as the humerus, femur and tibia. They are also for use in fixation of non-unions or malunions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

Device Story

ChM 4.5mm Cortical screws are single-use, metallic bone fixation fasteners; used for open reduction and internal fixation of long bone fractures and non-unions. Device features self-tapping threads and hexdrive head recess. Implantation performed by surgeons in operating room settings. Screws act as load-sharing devices to stabilize bone segments during healing; may be removed post-healing. Benefit includes mechanical stabilization of bone fractures to facilitate union.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical biomechanical testing (ASTM F543-17) and biocompatibility evaluation (ISO 10993-1).

Technological Characteristics

Material: Titanium alloy (ISO 5832-11/ASTM F1295-16). Design: Self-tapping, hexdrive head, various lengths. Mechanical: Load-sharing bone fixation fastener. Sterilization: Non-sterile (requires user sterilization).

Indications for Use

Indicated for fixation of long bones (humerus, femur, tibia) and non-unions/malunions in adults, children (2-12 years), and adolescents (12-21 years) where growth plates are fused or will not be crossed by screw fixation.

Regulatory Classification

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.

Predicate Devices

• Synthes Cortical Screws (K112583)

Submission Summary (Full Text)

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ChM sp. z o.o. Boguslaw Krzywicki Certification and Registration Specialist Lewickie 3b Juchnowiec Koscielny, Podlaskie 16-061 Poland

Re: K210490

Trade/Device Name: ChM 4.5mm Cortical screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: December 1, 2020 Received: February 19, 2021

Dear Boguslaw Krzywicki:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

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

510(k) Number (if known) K210490

Device Name ChM 4.5mm Cortical screws

#### Indications for Use (Describe)

The ChM 4.5mm Cortical screws are intended for fixation of various long bones, such as the humerus, femur and tibia. They are also for use in fixation of non-unions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

Type of Use (Select one or both, as applicable)

| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|------------------------------------------------------------|-----------------------------------------------------------|
|------------------------------------------------------------|-----------------------------------------------------------|

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Image /page/3/Picture/0 description: The image shows a logo with the text "lat ChM". The "lat" is written in a cursive font and is black. The "ChM" is written in a sans-serif font and is red. There is a faded gray number "40" in the background. The logo appears to be for an organization or event celebrating 40 years.

| Company | ChM sp. z o.o.<br>Lewickie 3b,<br>16-061 Juchnowiec Kościelny<br>Tel: + 48 85 86 86 100;<br>Fax: + 48 85 86 86 101 |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Bogusław Krzywicki<br>Certification and Registration Specialist<br>ChM sp. z o.o.<br>Tel: + 48 85 86 86 306;<br>Fax: + 48 85 86 86 101<br>Email: [e-mail] |
| Date Prepared | September 29, 2021 |

NIP 966-11-76-019 REGON 050561656 BDO: 000002928 Sąd Rejonowy w Białymstoku XII Wydział Gospodarczy: KRS 0000187570 Wysokość kapitału zakładowego 9 050 000 zł

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Image /page/4/Picture/0 description: The image shows the logo for CHM sp. z o.o. The logo consists of the letters "CHM" in a stylized red font, with the letters connected to each other. Below the letters, the text "sp. z o.o." and "Lewickie 3b" are written in a smaller, black font. A registered trademark symbol is located in the upper right corner of the logo.

Date: 2021-09-29 Rev .: 02

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| Device Trade Name | ChM 4.5mm Cortical screws |
|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k number | K210490 |
| Device Common Name | Bone screws |
| Classification Name: | Smooth or threaded metallic bone fixation fastener (21<br>C.F.R. 888.3040) |
| Product Code | HWC |
| Predicate Device(s) | ChM 4.5mm Cortical screws were shown to be<br>substantially equivalent to the:<br><br>K112583 – Synthes Cortical Screws<br><br>Substantial equivalence for ChM 4.5mm Cortical screws<br>is based on its similarities in: material, design features,<br>indications for use, patient population, performance<br>requirements, and operational principles when compared<br>to the predicate devices cleared under the above-<br>mentioned submission. |
| Device Description | This Traditional 510(k) submission is being supplied to<br>the U.S. FDA to seek clearance to market the new ChM<br>4.5mm Cortical screws.<br><br>The ChM 4.5mm Cortical screws are single-use, stand<br>alone, open reduction and internal fixation devices. They<br>have self-tapping features, hexdrive head recess, and are<br>manufactured from titanium alloy in accordance with ISO<br>5832-11/ ASTM F1295-16. The ChM 4.5mm Cortical<br>screws are offered non-sterile only and are available in<br>various lengths. The device is meant to be used as a load<br>sharing device, and it may be removed once the fracture<br>is healed.<br><br>Implantation with use of cortical screws should be<br>performed in the operating room conditions. |
| Intended use and<br>Indications for Use | The ChM 4.5mm Cortical screws are intended for fixation<br>of various long bones, such as the humerus, femur and<br>tibia. They are also for use in fixation of non-unions or<br>malunions in adults and in both children (2-12 years) and<br>adolescents (12-21 years) in which growth plates have<br>fused or in which growth plates will not be crossed by<br>screw fixation. |
| Comparison of<br>Technological<br>characteristics with the<br>Predicate Device | The ChM 4.5mm Cortical screws have similar<br>technological characteristics to the identified predicate.<br>The material, design features, indications for use, patient<br>population, performance requirements, and operational<br>principles are equivalent to the predicate device. |
| | A review of the test data for the subject devices indicates<br>that they are capable of withstanding expected in vivo<br>loading without failure. |
| Performance Data | Non-clinical Testing<br>Non-clinical, biomechanical testing as specified in the<br>ASTM F543 – 17 was performed on the ChM 4.5mm<br>Cortical screws to determine substantial equivalence.<br>Testing demonstrated that the ChM 4.5mm Cortical<br>screws are substantially equivalent to the predicate<br>device currently cleared for marketing.<br>Safety in MRI Not Evaluated.<br><br>Biocompatibility Testing<br>The biocompatibility evaluation (ISO 10993-1 Fifth edition<br>2018-08) was performed to evaluate the biological safety<br>of ChM 4.5mm Cortical screws according to FDA<br>Guidance: Use of International Standard ISO 10993-1,<br>"Biological evaluation of medical devices – Part 1:<br>Evaluation and testing within a risk management<br>process". According to ISO 10993-1 Annex A, the<br>implants belong to „Implant medical device" category,<br>principally contacting tissue and bone, duration of contact<br>exceeds 30 days (long term contact).<br>The material is titanium alloy as per ISO 5832-11/ ASTM<br>F1295-16. |
| | ChM 4.5mm Cortical screws are biocompatible.<br>Animal Testing<br>Animal testing was not required for this submission.<br>Clinical Testing<br>Clinical testing was not required for this submission. |
| Substantial<br>Equivalence<br>Conclusion | Based upon a comparison of the material, design<br>features, indications for use, patient population,<br>performance requirements, and operational principles, the<br>subject ChM 4.5mm Cortical screws are substantially<br>equivalent to the predicate device identified in this<br>premarket notification.<br>ChM 4.5mm Cortical screws manufactured by ChM sp. z<br>o.o. proved to perform at least as well as the predicate<br>device. |

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Image /page/5/Picture/0 description: The image shows a logo with the letters "CHM" in a stylized, red font. Below the letters, there is the text "sp. z o.o. Lewickie 3b" in black font. To the right of the letters, there is a circled "R" symbol, indicating a registered trademark.

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Image /page/6/Picture/0 description: The image shows a logo with the letters "CHM" in red, stylized to appear hand-drawn. Below the letters, there is the text "sp. z o.o." followed by "Lewickie 3b" in a smaller, sans-serif font. A circled "R" trademark symbol is located in the upper right corner of the logo.

Date: 2021-09-29 Rev .: 02