Forma Medical Headless Compression Screw
Device Facts
| Record ID | K230945 |
|---|---|
| Device Name | Forma Medical Headless Compression Screw |
| Applicant | Forma Medical, Inc. |
| Product Code | HWC · Orthopedic |
| Decision Date | Jul 18, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3040 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
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 Story
Forma Medical Headless Compression Screws are orthopedic implants designed to provide relative stability for bone fracture fixation and arthrodesis. The system consists of headless screws available in various diameters and lengths to accommodate patient anatomy, along with associated surgical instrumentation. Used in clinical settings by surgeons, the screws are implanted to hold bone fragments together, facilitating healing and joint fusion. The device functions by providing mechanical compression across the fracture or fusion site. Benefits include stabilization of small bone fragments and joints, aiding in patient recovery. The system is manual; no software or algorithms are involved.
Clinical Evidence
Bench testing only. Mechanical evaluation compared the subject device to predicate devices regarding torsional strength, insertion/removal torque, and pullout strength per ASTM F543.
Technological Characteristics
Materials: Titanium alloy, cobalt chromium molybdenum alloy, stainless steel (ASTM F136, F1537, F138). Form factor: Headless bone screws, various diameters (1.5mm–4.0mm) and lengths (9mm–52mm). Features: Cannulated and solid options. Energy source: None (manual). Sterilization: Not specified. Connectivity: None. Software: None.
Indications for Use
Indicated for fixation of intra-articular and extra-articular fractures, avulsions, non-unions, and osteotomies of small bone fragments, and arthrodesis of small joints.
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 (USA) 1.5mm Headless Compression Screws (K090949)
Reference Devices
- Globus Medical CAPTIVATETM Compression Screws (K162825)
- OsteoMed ExtremiFix Mini & Small Cannulated Screw System (K202680)
Submission Summary (Full Text)
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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)
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.
| 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.<br>3401 Hartzdale Drive<br>Suite 103B, Unit #611<br>Camp Hill, PA 17011 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | 07/11/2023 |
| Contact Person:<br>Contact Telephone:<br>Contact Fax: | Kyle Kovach, Sr. Quality and Regulatory Engineer, JALEX Medical<br>(440) 787-5832<br>(440) 933-7839 |
| Device Trade Name:<br>Common Name:<br>Device Classification Name:<br>Device Classification:<br>Reviewing Panel:<br>Product Code:<br>Primary Predicate Device:<br>Reference Devices: | Forma Medical Headless Compression Screw<br>Screw, Fixation, Bone<br>Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040)<br>Class II<br>Orthopedic<br>HWC<br>Synthes (USA) 1.5mm Headless Compression Screws (K090949)<br>Globus Medical CAPTIVATETM Compression Screws (K162825)<br>OsteoMed ExtremiFix Mini & Small Cannulated Screw System<br>(K202680) |
#### 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.
#### Indications for Use:
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.
#### 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 Medical<br>Headless<br>Compression<br>Screw | Synthes (USA)<br>1.5mm Headless<br>Compression<br>Screws<br>(K090949) | Globus Medical<br>CAPTIVATE™<br>Compression<br>Screws<br>(K162825) | OsteoMed<br>ExtremiFix Mini<br>& Small<br>Cannulated<br>Screw System<br>(K202680) | Comparison | |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Classification<br>Name | Smooth or<br>threaded metallic<br>bone fixation<br>fastener | Smooth or<br>threaded metallic<br>bone fixation<br>fastener | Smooth or<br>threaded metallic<br>bone fixation<br>fastener | Smooth or<br>threaded metallic<br>bone fixation<br>fastener | Equivalent | |
| Regulation | 888.3040 | 888.3040 | 888.3040 | 888.3040 | Equivalent | |
| Product Code | HWC | HWC | HWC | HWC, HTN | Equivalent | |
| Indications<br>for Use | Forma Medical<br>Headless<br>Compression<br>Screws are<br>indicated for<br>fixation of intra-<br>articular and extra<br>articular fractures,<br>avulsions, non-<br>unions, and<br>osteotomies of<br>small bones and<br>small bone<br>fragments; as well<br>as arthrodesis of<br>small joints. | Synthes 1.5mm<br>Headless<br>Compression<br>Screws are<br>indicated for<br>fixation of intra-<br>articular and<br>extra-articular<br>fractures,<br>avulsions, non-<br>unions, and<br>osteotomies of<br>small bones and<br>small bone<br>fragments; as well<br>as arthrodesis of<br>small joints. | CAPTIVATE™<br>Compression<br>Screws are<br>indicated for use<br>in adult and<br>pediatric patients,<br>for fracture repair<br>and fixation,<br>osteotomy, joint<br>fusion,<br>reconstruction<br>and arthrodesis of<br>bones appropriate<br>for the size of the<br>device.<br><br>CAPTIVATE™<br>VL Compression<br>Screws are<br>indicated for use<br>in adult and<br>pediatric patients,<br>for fracture repair<br>and fixation,<br>osteotomy, joint<br>fusion,<br>reconstruction<br>and arthrodesis of<br>the phalanges,<br>metacarpals,<br>carpals,<br>metatarsals,<br>midfoot, hind<br>foot, ankle, fibula,<br>distal tibia,<br>proximal tibia,<br>radius, ulna,<br>humerus, and<br>clavicle. | The Osteomed<br>ExtremiFix Mini<br>& Small<br>Cannulated Screw<br>System is<br>indicated for use<br>in bone<br>reconstruction,<br>osteotomy,<br>arthrodesis, joint<br>fusion, fracture<br>repair, and<br>fracture fixation<br>of bones<br>appropriate for<br>the size of the<br>device. Screws<br>are intended for<br>single use only. | Equivalent<br>to primary<br>predicate | |
| Description | Forma Medical<br>Headless<br>Compression | The Synthes<br>1.5mm Headless<br>Compression | CAPTIVATE™<br>Compression | The OsteoMed<br>Mini & Small<br>Cannulated Screw | Substantially<br>Equivalent | |
| | Screws are<br>designed to hold<br>bones in relative<br>stability for<br>fracture fixation<br>and arthrodesis.<br>The screws are<br>available in<br>multiple<br>diameters and<br>lengths based on<br>patient anatomy<br>and clinical<br>application. The<br>screws are<br>manufactured<br>from titanium<br>alloy, cobalt<br>chromium<br>molybdenum<br>alloy, or stainless<br>steel, as specified<br>in ASTM F136,<br>F1537, and F138.<br>The system<br>includes screws<br>and instruments.<br>The system<br>instrumentation is<br>manufactured<br>from stainless<br>steel, aluminum,<br>and other surgical<br>grade materials. | Screws are solid<br>bone fixation<br>screws featuring a<br>partially threaded<br>shaft and threaded<br>head. The screws<br>are available in<br>stainless steel and<br>titanium. | bone screws<br>designed to<br>compact<br>juxtaposed bone<br>for reconstruction<br>and enhanced<br>arthrodesis. The<br>implants are<br>available in<br>various diameters<br>and lengths to<br>accommodate<br>patient anatomy,<br>with headless,<br>partially or fully<br>threaded, solid or<br>cannulated, and<br>variable length<br>(VL) options.<br>CAPTIVATE™<br>implants are<br>manufactured<br>from titanium<br>alloy, cobalt<br>chromium<br>molybdenum<br>alloy, or stainless<br>steel, as specified<br>in ASTM F136,<br>F1295, F1472,<br>F1537 and F138. | System is<br>comprised of<br>screws and<br>washers used for<br>bone fixation of<br>the hand and foot<br>following trauma<br>or osteotomy. The<br>System features<br>cannulated screws<br>in the following<br>dimensions:<br>2.0mm screw<br>diameter- 6mm to<br>42mm screw<br>length;<br>2.4mm screw<br>diameter- 6mm to<br>50mm screw<br>length;<br>3.0mm screw<br>diameter- 10mm<br>to 40mm screw<br>length;<br>4.0mm screw<br>diameter- 12mm<br>to 52mm screw<br>length;<br>The system<br>instruments<br>include depth<br>gauges,<br>screwdrivers,<br>countersinks,<br>guide wires, and<br>other instruments<br>to facilitate the<br>placement of<br>screws.<br>The implants<br>(screws and<br>washers) of the<br>OsteoMed Mini<br>& Small<br>Cannulated Screw<br>System are made<br>from titanium<br>alloy (ASTM<br>F136). | Equivalent<br>to Globus<br>reference<br>predicate | |
| Material | Titanium Alloy,<br>Cobalt Chromium<br>Molybdenum<br>Alloy, and | Titanium alloy,<br>stainless steel | Titanium Alloy,<br>Cobalt Chromium<br>Molybdenum<br>Alloy, and | Titanium alloy<br>per ASTM F136 | | |
| | Stainless steel per<br>ASTM F136,<br>F1537, and F138 | Stainless steel per<br>ASTM F136,<br>F1295, F1472,<br>F1537, and F138 | | | | |
| Lengths | Ø1.5 mm: 9-20 mm<br>Ø2.0 mm: 10-42 mm<br>Ø2.5 mm: 10-50 mm<br>Ø3.0 mm: 12-40 mm<br>Ø4.0 mm: 14-52 mm | Ø2.5 mm: 9-40 mm<br>Ø3.0 mm: 10-40 mm<br>Ø4.0 mm: 16-60 mm | Ø2.0 mm: 6-42 mm<br>Ø2.5 mm: 6-50 mm<br>Ø3.0 mm: 10-40 mm<br>Ø4.0 mm: 12-52 mm | Ø1.5 mm equivalent to primary predicate<br>and Ø2.0-4.0 mm equivalent to OsteoMed reference predicate | | |
| | Cannulation | Ø1.5 mm: Solid<br>Ø2.0-4.0 mm: Cannulated | Solid | Solid and cannulated | Cannulated | Ø1.5 mm equivalent to primary predicate<br>and 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.
