(187 days)
No
The 510(k) summary describes a traditional bone plating system and its mechanical testing, with no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as "designed to hold bones in relative stability for fracture fixation and arthrodesis," which indicates it is a surgical implant for structural support and healing, not a therapeutic device that delivers a treatment or performs a therapeutic function.
No
The device is described as a system for fracture fixation and bone reconstruction, essentially a hardware system (plates, screws, and instruments) for stabilizing bones, not for diagnosing medical conditions.
No
The device description explicitly states that the system includes plates, screws, and instruments, which are physical hardware components made of various metals.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Forma Medical Optimal Plating System is a system of plates and screws intended for the fixation of bones during surgery. It is an implantable device used directly on the patient's anatomy.
- Intended Use: The intended use clearly states it's for "fixation of fractures, osteotomies, arthrodeses, and bone reconstructions." This is a surgical intervention, not a diagnostic test performed on a sample.
The device is a surgical implant system, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
flat (scapula), long (clavicle, upper and lower extremities including metacarpals, and phalanges), irregular (pelvis, hand, foot) bones and joints (wrist, ankle). Not indicated for ribs, sternum, spine, or the skull.
Indicated Patient Age Range
adult patients
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 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.
Key Results:
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
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.
Globus Medical ANTHEM® Fracture System (K180554)
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.
Nova Step Airlock® (K151277, K143523), APTUS Foot System (K142581)
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
§ 888.3030 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.
0
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"
1
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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Forma Medical Optimal Plating System
Indications for Use (Describe)
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.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 Drive
Suite 103B, Unit #611
Camp 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, Bone
Screw, Fixation, Bone |
| Device Classification Name: | Single/multiple component metallic bone fixation appliances and
accessories
Smooth 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:
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.
Indications for Use:
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.
4
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 Optimal
Plating System | Globus Medical
ANTHEM® Fracture System
(K180554) | Nova Step
Airlock®
(K151277, K143523) | APTUS Foot System
(K142581) | Comparison |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification
Name | Single/multiple component
metallic bone fixation
appliance and accessories
Smooth or threaded metallic
bone fixation fastener | Single/multiple component
metallic bone fixation appliance
and accessories
Smooth or threaded metallic
bone fixation fastener | Single/multiple
component metallic bone
fixation appliance and
accessories | Single/multiple component
metallic bone fixation
appliance 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 |
| Indications
for Use | 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, metatarsals, and
phalanges), irregular (pelvis,
hand, foot) bones and joints
(wrist, ankle). The Forma
Medical Optimal Plating
System is not indicated for | The ANTHEM® Fracture
System is indicated for fixation
of fractures, osteotomies,
arthrodesis and reconstruction
of bones for the appropriate size
of the device to be used in adult
patients, 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 be
used for dislocations of the
acromioclavicular joint. Mini
fragment plates are also | The Airlock®
osteosynthesis plate
systems are indicated for
stabilization and fixation
of fresh fractures,
revision procedures, joint
fusions and
reconstruction of small
bones of the hands, feet,
wrists and ankles, fingers
and toes. The system
may be used in both adult
and pediatric patients. | The APTUS® Foot System is
intended for use in small
bones, in particular in
fractures, osteotomies and
arthrodesis of the tarsals,
metatarsals and phalanges. | Equivalent to
primary
predicate |
| | ribs, sternum, spine, or the
skull. | indicated for fixation of
fractures of the acetabulum,
patella, and bone fragments,
replantation, malunions and
nonunions, and for non-load
bearing stabilization and
reduction of long bone
fragments.
Small fragment, mini fragment,
proximal tibia, clavicle and
distal fibula plates may be used
in all pediatric subgroups
(except neonates) and small
stature adults. Distal radius and
mini fragment plates may be
used in adolescents (12-21
years of age).
Plating may be used in patients
with osteopenic bone. | | | |
| Description | The Forma Optimal Plating
System comprises a range of
plates and screws created for
internal bone fixation. These
implants come in a range of
sizes and shapes to suit
individual patient anatomy
and can be either contoured
or straight, featuring both
locking and non-locking
screws. Optimal implants are
crafted from materials
including titanium, titanium
alloy, cobalt chromium
molybdenum alloy, or
stainless steel, as outlined in
ASTM standards F67, F136,
F1295, F1472, F1537,
F2229, F138, and F139. All
implants are designed for
single-use only. | The ANTHEM® Fracture
System is a family of plates and
screws designed to be used for
internal bone fixation. The
implants are available in
various sizes and shapes to
accommodate patient anatomy,
and may be contoured or
straight, with locking and non-
locking screws. ANTHEM®
implants are manufactured from
titanium, titanium alloy, cobalt
chromium molybdenum alloy,
or stainless steel, as specified in
ASTM F67, F136, F1295,
F1472, F1537, F2229, F138 and
F139. All implants are for
single use only. | Airlock® osteosynthesis
plate systems are are
single-use bone fixation
devices intended to be
permanently implanted.
Plates are designed with
different shapes and are
made of Titanium (Alloy
Ti-6Al-4V ELI).
The system uses either
3mm or 3,5mm locking
and non-locking screws.
The drill hole are aligned
to make sure there-is no
risk of conflict between
the screws.
The plates vary
essentially through
different curvatures,
lengths, number of holes
and shape. | The subject device plates are
provided in a variety of
anatomical designs, in
various lengths, widths and
thicknesses. The plate
thickness varies from 1.6 mm
to 2.0 mm depending on the
design. The screw holes of
the subject device plates are
designed to accommodate
appropriately sized subject
device screws, or screws
presently marketed as part of
the APTUS System and
previously cleared under
K091479. The subject device
plates also are compatible
with K-wires cleared under
K092038. The subject device
plates are used with TriLock
locking screws and cortical | Equivalent to
primary
predicate |
| | | | | | (nonlocking) screws. All
subject device screws are
self-tapping and self-drilling
and provided in diameters of
2.0, 2.8 and 3.5 mm, and in
various lengths from 8 to 45
mm.
The subject device plates are
made of commercially pure
titanium, Grade 4,
conforming to ASTM F67
Standard Specification for
Unalloyed Titanium for
Surgical Implant
Applications (UNS R50250,
UNS R50400, UNS R50550,
UNS R50700). The subject
device screws are made of
titanium alloy conforming to
ASTM F136 Standard
Specification for Wrought
Titanium-6 Aluminum-4
Vanadium ELI (Extra Low
Interstitial) Alloy for
Surgical Implant
Applications (UNS R56401). |
| Material | Titanium Alloy,
Cobalt Chromium
Molybdenum Alloy, and
Stainless steel per ASTM
F67, F136, F1295, F1472,
F1537, F2229, F138 and
F139. | Titanium Alloy,
Cobalt Chromium Molybdenum
Alloy, and
Stainless steel per ASTM F67,
F136, F1295, F1472, F1537,
F2229, F138 and F139. | Titanium (Alloy Ti-6Al-
4V ELI). | Titanium Alloy per ASTM
F67, ASTM F136 | Equivalent to
primary
predicate |
| Plate Styles | Straight, Contourable, and
pre-shaped | Straight, Contourable, and pre-
shaped | Straight, Contourable,
and pre-shaped | Straight, Contourable, and
pre-shaped | Equivalent to
primary
predicate |
| 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 |
| Screw
Lengths | 6mm to 85mm | 6mm to 85mm | N/A | 8 to 45 mm | Equivalent |
5
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.
6
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.
7
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.
8
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 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 |
Conclusion:
Based on the indications for use, technological characteristics, and mechanical testing comparison with the predicate devices, the subject device has demonstrated substantial equivalence.