(105 days)
No
The 510(k) summary describes a mechanical implant (screws) and associated instruments for bone fixation. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are based on mechanical testing, not algorithmic performance.
No
The device is described as a screw designed for fixation of fractures, avulsions, non-unions, and osteotomies, as well as arthrodesis of small joints, which are structural repair functions rather than direct therapeutic treatments.
No
Explanation: The device is a surgical implant (screws) used for fixation of fractures and arthrodesis, not for diagnosing medical conditions.
No
The device description explicitly states that the device is a physical screw made from metallic alloys and includes instrumentation made from surgical grade materials. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the screws are for the fixation of fractures, avulsions, non-unions, osteotomies, and arthrodesis of bones and joints. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical implant (screws) and associated surgical instruments.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical repair.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HWC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Synthes (USA) 1.5mm Headless Compression Screws (K090949)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Globus Medical CAPTIVATETM Compression Screws (K162825), OsteoMed ExtremiFix Mini & Small Cannulated Screw System (K202680)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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.
1
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
2
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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3
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 Drive
Suite 103B, Unit #611
Camp 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 Screw
Screw, Fixation, Bone
Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040)
Class II
Orthopedic
HWC
Synthes (USA) 1.5mm Headless Compression Screws (K090949)
Globus Medical CAPTIVATETM Compression Screws (K162825)
OsteoMed ExtremiFix Mini & Small Cannulated Screw System
(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
Headless
Compression
Screw | Synthes (USA)
1.5mm Headless
Compression
Screws
(K090949) | Globus Medical
CAPTIVATE™
Compression
Screws
(K162825) | OsteoMed
ExtremiFix Mini
& Small
Cannulated
Screw System
(K202680) | Comparison | |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Classification
Name | Smooth or
threaded metallic
bone fixation
fastener | Smooth or
threaded metallic
bone fixation
fastener | Smooth or
threaded metallic
bone fixation
fastener | Smooth or
threaded metallic
bone fixation
fastener | Equivalent | |
| Regulation | 888.3040 | 888.3040 | 888.3040 | 888.3040 | Equivalent | |
| Product Code | HWC | HWC | HWC | HWC, HTN | Equivalent | |
| 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 bones and
small bone
fragments; as well
as arthrodesis of
small joints. | Synthes 1.5mm
Headless
Compression
Screws are
indicated for
fixation of intra-
articular and
extra-articular
fractures,
avulsions, non-
unions, and
osteotomies of
small bones and
small bone
fragments; as well
as arthrodesis of
small joints. | CAPTIVATE™
Compression
Screws are
indicated for use
in adult and
pediatric patients,
for fracture repair
and fixation,
osteotomy, joint
fusion,
reconstruction
and arthrodesis of
bones appropriate
for the size of the
device.
CAPTIVATE™
VL Compression
Screws are
indicated for use
in adult and
pediatric patients,
for fracture repair
and fixation,
osteotomy, joint
fusion,
reconstruction
and arthrodesis of
the phalanges,
metacarpals,
carpals,
metatarsals,
midfoot, hind
foot, ankle, fibula,
distal tibia,
proximal tibia,
radius, ulna,
humerus, and
clavicle. | The Osteomed
ExtremiFix Mini
& Small
Cannulated Screw
System is
indicated for use
in bone
reconstruction,
osteotomy,
arthrodesis, joint
fusion, fracture
repair, and
fracture fixation
of bones
appropriate for
the size of the
device. Screws
are intended for
single use only. | Equivalent
to primary
predicate | |
| Description | Forma Medical
Headless
Compression | The Synthes
1.5mm Headless
Compression | CAPTIVATE™
Compression | The OsteoMed
Mini & Small
Cannulated Screw | Substantially
Equivalent | |
| | 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. | Screws are solid
bone fixation
screws featuring a
partially threaded
shaft and threaded
head. The screws
are available in
stainless steel and
titanium. | bone screws
designed to
compact
juxtaposed bone
for reconstruction
and enhanced
arthrodesis. The
implants are
available in
various diameters
and lengths to
accommodate
patient anatomy,
with headless,
partially or fully
threaded, solid or
cannulated, and
variable length
(VL) options.
CAPTIVATE™
implants are
manufactured
from titanium
alloy, cobalt
chromium
molybdenum
alloy, or stainless
steel, as specified
in ASTM F136,
F1295, F1472,
F1537 and F138. | System is
comprised of
screws and
washers used for
bone fixation of
the hand and foot
following trauma
or osteotomy. The
System features
cannulated screws
in the following
dimensions:
2.0mm screw
diameter- 6mm to
42mm screw
length;
2.4mm screw
diameter- 6mm to
50mm screw
length;
3.0mm screw
diameter- 10mm
to 40mm screw
length;
4.0mm screw
diameter- 12mm
to 52mm screw
length;
The system
instruments
include depth
gauges,
screwdrivers,
countersinks,
guide wires, and
other instruments
to facilitate the
placement of
screws.
The implants
(screws and
washers) of the
OsteoMed Mini
& Small
Cannulated Screw
System are made
from titanium
alloy (ASTM
F136). | Equivalent
to Globus
reference
predicate | |
| Material | Titanium Alloy,
Cobalt Chromium
Molybdenum
Alloy, and | Titanium alloy,
stainless steel | Titanium Alloy,
Cobalt Chromium
Molybdenum
Alloy, and | Titanium alloy
per ASTM F136 | | |
| | Stainless steel per
ASTM F136,
F1537, and F138 | Stainless steel per
ASTM F136,
F1295, F1472,
F1537, and F138 | | | | |
| Lengths | Ø1.5 mm: 9-20 mm
Ø2.0 mm: 10-42 mm
Ø2.5 mm: 10-50 mm
Ø3.0 mm: 12-40 mm
Ø4.0 mm: 14-52 mm | Ø2.5 mm: 9-40 mm
Ø3.0 mm: 10-40 mm
Ø4.0 mm: 16-60 mm | Ø2.0 mm: 6-42 mm
Ø2.5 mm: 6-50 mm
Ø3.0 mm: 10-40 mm
Ø4.0 mm: 12-52 mm | Ø1.5 mm equivalent to primary predicate
and Ø2.0-4.0 mm equivalent to OsteoMed reference predicate | | |
| | Cannulation | Ø1.5 mm: Solid
Ø2.0-4.0 mm: Cannulated | Solid | Solid and cannulated | Cannulated | Ø1.5 mm equivalent to primary predicate
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.