(93 days)
Not Found
No
The device description and intended use are solely focused on the physical components (screws, plates, K-wires) and their mechanical function in fracture fixation. There is no mention of any software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
The device is described as "Orthopedic Fixation Systems (OFS) consists of various plates, screws and K-Wires that can be provided in sets or individually", and its intended use is for "Fixation and stabilization of fractures", which clearly indicates a therapeutic purpose.
No.
The device is used for fixation and stabilization of fractures, which is a therapeutic or surgical procedure. The text describes it as orthopedic fixation systems consisting of plates, screws, and wires used in fracture fixation, not for fracture diagnosis.
No
The device description explicitly states it consists of physical components (plates, screws, and K-Wires) made of stainless steel, which are hardware, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The provided text clearly describes the device as orthopedic implants (screws, plates, and K-wires) used for the fixation and stabilization of fractures in bones. This is a surgical procedure performed within the body (in vivo).
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, performing tests on samples, or providing diagnostic information based on laboratory analysis.
The device described is a surgical implant used for structural support within the body, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The Impact Medical, LLC screws, plates, and K-Wires are single use, non-sterile and are indicated for use in:
- . Fixation and stabilization of fractures in small and long bones; including at a minimum: the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, clavicle, humerus, ulna, middle foot bones, calcaneus and for fixation of fractures in the proximal femur and trochanteric, intertrochanteric, and basilar neck fractures.
- . Kirschner (K) wires are used in support of fracture fixation, for ostedtomies in the presence of adequate immobilization and implant guide wires.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC, HTY
Device Description
The Impact Medical, LLC Orthopedic Fixation Systems (OFS) consists of various plates, screws and K-Wires that can be provided in sets or individually. Sets are designed for a specific plate and screw combination. They are sold Non-Sterilized by the facility according to a validated and monitored hospital or facility protocol prior to use. All plates, screws and wires are made from 316L stainless steel that meets ASTM F138 Standard Specification for Wrought 18-Chromium-14Nickel-2.5 Molybenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673) 2008. The screws are in various sizes of Cancellous, Cortex, Cannulated, Locking and Headless Compression. Inclinal, LLC's Orthopedic Fixation System (OFS) of plates, screws and wires are single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, clavicle, humerus, ulna, middle foot bones, calcaneus, proximal femur, trochanteric, intertrochanteric, basilar neck fractures.
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)
Non-Clinical Performance and Testing: Impact Medical, LLC has confirmed that or hopedic Fixation Systems meet the established requirements and the systems have been tested for compliance with standards in comparison with the predicates. Testing was a combination of Monotonic and cyclic bending tests of plates, insertion/removal, torsion and pullout of screws, and geometric analysis. The product bench and standards comparison testing with the predicated that the devices were safe and effective and substantially equivalent to product already on the market.
Clinical Testing: No clinical testing was required nor was performed.
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.
K110086, K962011, K071035, K061620, K000684, K043185, K021556
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.
Not Found
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 for Impact Medical. The word "Impact" is in bold, italicized, black font. To the right of the word "Impact" is a target symbol. To the right of the target symbol is the word "Medical" in bold, black font.
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MAY 0 1 2014
Impact Medical, LLC 510(k) Summary
Date Prepared:
April 29, 2014
Contact Details
| Applicant Name: | Impact Medical, LLC
EJ Duffy, President
10110 SW Nimbus Avenue
Suite B-6
Portland, OR 97223
Tel: 503-521-7669
Fax: 503-521-7380 |
| ----------------- | --------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Contact Name | Madalyn Duncan |
|---|---|
| Regulatory/Quality Contact | |
| 1-503-521-7669 |
Device Information
| Type of 510(K): | Traditional 510(k) |
|---|---|
| Device Trade Name: | Orthopedic Fixation Systems (OFS) |
| Device Common Name: | Plates: Fixation Bone |
| Screws: Fixation Bone | |
| Wires | |
| Device Trade Name: | Orthopedic Fixation Systems (OFS) |
| Product Code (s): | HRS: Plate, Fixation, Bone |
| HWC: Screws, Fixation, Bone | |
| HTY: Pin, Fixation, Smooth | |
| Classification Regulation: | Title 21 CFR 888.3030: Single/multiple component metallic fixation appliances and accessories |
| Title 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener | |
| Classification: | Class II |
| Classification Panel: | Orthopedics |
Legally Marketed Predicate Device (s)
510(k)'s: K110086, K962011, K071035, K061620, K000684, K043185, K021556
1
Image /page/1/Picture/2 description: The image shows the logo for Impact Medical. The word "Impact" is in bold, italicized, and black font. To the right of the word "Impact" is a graphic of a target. To the right of the target is the word "Medical" in bold, black font.
Description
The Impact Medical, LLC Orthopedic Fixation Systems (OFS) consists of various plates, screws and K-Wires that can be provided in sets or individually. Sets are designed for a specific plate and screw combination. They are sold Non-Sterilized by the facility according to a validated and monitored hospital or facility protocol prior to use. All plates, screws and wires are made from 316L stainless steel that meets ASTM F138 Standard Specification for Wrought 18-Chromium-14Nickel-2.5 Molybenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673) 2008. The screws are in various sizes of Cancellous, Cortex, Cannulated, Locking and Headless Compression. Inclinal, LLC's Orthopedic Fixation System (OFS) of plates, screws and wires are single use only.
Intended Use/Indications for Use
The Impact Medical, LLC screws, plates, and K-Wires are single use, non-sterile and are indicated for use in:
- . Fixation and stabilization of fractures in small and long bones; including at a minimum: the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, clavicle, humerus, ulna, middle foot bones, calcaneus and for fixation of fractures in the proximal femur and trochanteric, intertrochanteric, and basilar neck fractures.
- . Kirschner (K) wires are used in support of fracture fixation, for ostedtomies in the presence of adequate immobilization and implant guide wires.
Substantial Equivalence Comparison
Impact Medical, LLC Orthopedic Fixation Systems have regulatory classification, similar indications for use, similar performance characteristics, and all systems have the predicates. The devices have been tested in comparison with the predicate and demonstrated to be safe and effective for their intended use.
Non-Clinical Performance and Testing
Impact Medical, LLC has confirmed that or hopedic Fixation Systems meet the established requirements and the systems have been tested for compliance with standards in comparison with the predicates. Testing was a combination of Monotonic and cyclic bending tests of plates, insertion/removal, torsion and pullout of screws, and geometric analysis. The product bench and standards comparison testing with the predicated that the devices were safe and effective and substantially equivalent to product already on the market.
Clinical Testing
No clinical testing was required nor was performed.
Conclusions
Impact Medical, LLC Orthopedic Fixation Systems have intended use, materials and performance characteristics as the predicates. Therefore, Impact Medical, LC believes the systems to be substantially equivalent to the predicates.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, rendered in a bold, black line.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 1, 2014
Impact Medical, LLC Mr. E.J. Duffy Chief Executive Officer 10110 SW Nimbus Avenue, Suite B6 Portland, Oregon 97223
Re: K140216
Trade/Device Name: Orthopedic Fixation Systems (OFS) 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, HTY Dated: April 16, 2014 Received: April 17, 2014
Dear Mr. Duffy:
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. 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.
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 (reporting of medical
3
Page 2 - Mr. E.J. Duffy
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K 140216
Device Name: Orthopedic Fixation Systems (OFS)
Indications for Use:
The Impact Medical, LLC screws, plates, k-wires and are single use, non-sterile and are indicated for use in:
- fixation and stabilization of fractures in small and long bones; including at a minimum the . tibia , fibula, femoral condyle, pelvis, acetabulum, metacarpals, clavicle, humerus, ulna, middle hand and middle foot bones, calcaneus and for fixation of fractures in the proximal femur and trochanteric, pertrochanteric, intentrochanter ic, and basilar neck fractures
- Kirschner (K) wires are used in support of fracture fixation, for osteotomies in the presence of adequate immobilization and implant guide wires
______________________________________________________________________________________________________________________________________________________________________________ Prescription Use (Part 21 CFR 801 Subpart D)
OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOTWRITE BELOWTHIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
2014.04.29 08:39:14