(623 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of metal implants (plates and screws) for fracture fixation. There is no mention of AI, ML, image processing, or any software-based analysis or decision-making.
No
Explanation: The device is intended for the fixation and consolidation of fractures and osteotomies, which is a structural support function rather than a therapeutic one (e.g., delivering medication, stimulating healing, or actively treating a disease).
No
The device, Traufix osteosynthesis medical devices, is described as metal implants for the fixation of fractures and osteotomies. Its intended use focuses on treatment and consolidation, not on diagnosing medical conditions.
No
The device description explicitly states that the devices are "metal implants" and includes details about the materials used (stainless steel, titanium-alloy) and the types of hardware (plates and screws). This indicates a physical medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of fractures and osteotomies of various bones. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as metal implants (plates and screws) fixed adjacent to the bone. These are physical devices used to stabilize bone structures.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
The description clearly indicates a device used for surgical intervention and physical support of bone, not for testing biological samples.
N/A
Intended Use / Indications for Use
Traufix medical devices are intended for fixation of fractures and osteotomies of various bones including the pelvis, clavicle, scapula, humerus, ulna, radius, femur, tibia, olecranon, and fibula.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
Traufix osteosynthesis medical devices are metal implants (stainless steel per ASTM F138, or ASTM F139, or titanium-alloy per ASTM F136) fixed adjacent to the bone for the treatment and consolidation of fractures, osteotomies, and/or joint ossification. The devices include different types and sizes of plates and screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvis, clavicle, scapula, humerus, ulna, radius, femur, tibia, olecranon, and fibula.
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 testing was performed in the subject devices as follows:
-Single cycle bend testing was performed according to ASTM F382.
-Breaking torque testing was performed according to ISO 6475.
-Engineering analysis was performed to compare the structural properties per ASTM F382 A1 (bending stiffness, bending structural stiffness, and bending strength) of the proximal tibia plate (subject device) and proximal tibia plate (predicate device one).
-Engineering analysis and comparison of technology was also provided to compare design and dimensions of the subject and predicate plates and screws.
Clinical testing is not a prerequisite, as osteosynthesis, osteotomy, and arthrodesis implants conform to recognized standards and have well established safety and performance characteristics. Therefore, clinical information is not necessary to demonstrate safety and effectiveness or substantial equivalence.
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.
K141680, K063049, K001945, K071184, K011335, K051986, K041860
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 date March 18, 2022. The text is written in a clear, sans-serif font. The date is written in the standard US format, with the month first, followed by the day and year. The text is centered and takes up most of the image.
FDA U.S. FOOD & DRUG
ADMINISTRATION
Fixier, S.A. de C.V. % Aurelia Brownridge Regulatory Affairs Consultant Aurelia Brownridge 11594 Cesped Drive San Diego, California 92124
Re: K201510
Trade/Device Name: Traufix osteosynthesis, osteotomy, and arthrodesis devices 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
Dear Aurelia Brownridge:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 18, 2022. Specifically, FDA is updating this SE Letter as an administrative correction, as two copies of the SE letter were sent in error along with the Indications for Use statement for K201510, but not the 510(k) Summary.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Shumaya Ali, M.P.H., OHT6: Office of Orthopedic Devices, (301) 796-2356, shumaya.ali@fda.hhs.gov.
Sincerely,
Shumaya Ali -S
Shumaya Ali, MPH 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
1
February 18, 2022
Image /page/1/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized depiction of a human figure. The FDA logo is on the right and includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Fixier, S.A. de C.V. % Aurelia Brownridge Regulatory Affairs Consultant Aurelia Brownridge 11594 Cesped Drive San Diego, California 92124
Re: K201510
Trade/Device Name: Fixier osteosynthesis, osteotomy, and arthrodesis devices 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: January 15, 2022 Received: January 20, 2022
Dear Aurelia Brownridge:
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.
2
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,
Shumava Ali -
Shumaya Ali, MPH 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
Enclosure
3
Indications for Use
510(k) Number (if known) K201510
Device Name
Traufix osteosynthesis, osteotomy, and arthrodesis devices
Indications for Use (Describe)
Traufix medical devices are intended for fixation of fractures and osteotomies of various bones including the pelvis, clavicle, scapula, humerus, ulna, radius, femur, tibia, olecranon, and fibula.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
510(k) Summary - K201510
The following 510(k) summary has been prepared pursuant to requirements specified in 21 CFR 807.92.
510(k) Bundle: This submission includes a range of Fixier's products with the same regulation classification and regulation code name.
Date Summary Prepared: February 15, 2022
Manufacturer and Contact Information:
| Submitter's
Name | Submitter's
Physical Address | Submitter's
Contact Information |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fixier, S.A. de
C.V. | Carretera Doctor Mora a San Miguel
de Allende km 3.4, C.P. 37967
Comunidad de San Rafael, Doctor
Mora, Guanajuato, México | Primary Official Contact:
Aurelia Brownridge
Regulatory Affairs (Consultant)
Telephone: 760-497-4354
Secondary Contact:
Vianey Mariana Perez Suarez
Biological and Pharmaceutical
Chemistry
Regulatory Affairs Chief |
| | | Telephone: 011-52-419-688-11-91 |
Device and Classification Information:
| Proprietary Name: | Traufix osteosynthesis, osteotomy, and arthrodesis devices |
|---|---|
| Common Name: | Plate, Fixation, Bone (primary) |
| Screw, Fixation, Bone | |
| Classification Name: | Single/multiple component metallic bone fixation appliances and |
| accessories (primary) | |
| Smooth or threaded metallic bone fixation fastener | |
| Regulatory Class: | II |
| Product Codes: | HRS (primary) |
| HWC | |
| Regulation Number: | 21 CFR 888.3030 (primary) |
| 21 CFR 888.3040 |
5
Indications for Use: Traufix medical devices are intended for fixation of fractures and osteotomies of various bones including the pelvis, clavicle, scapula, humerus, ulna, radius, femur, tibia, olecranon, and fibula.
Description: Traufix osteosynthesis medical devices are metal implants (stainless steel per ASTM F138, or ASTM F139, or titanium-alloy per ASTM F136) fixed adjacent to the bone for the treatment and consolidation of fractures, osteotomies, and/or joint ossification. The devices include different types and sizes of plates and screws. The product's list is shown below:
| Plate
type | Plate
code | Plate
description | Screw
code | Screw description | Surgical
technique # | Surgical technique
name |
|--------------------|-------------------------------------|-----------------------------------------------------------------|---------------|------------------------------------------------------|-------------------------|-------------------------------------------------------------------------------------------------------------------|
| Mini
fragments | 017 | 2.7 DCP Plates | 064 | 2.7mm cortex screw | | DCP plates |
| | 207 | 2.0 DCP Plates | 079 | 2.0mm cortex screw | TQ-005 | |
| | 202
&
203 | 2.7mm L-plate | 064 | 2.7mm cortex screw | TQ-032 | T and L plates for
3.5mm, 2.7mm, and
2.0mm screws |
| | 016 | 3.5mm One-
third tubular
plate | 057 | 3.5mm cortex screw | TQ-004 | 3.5mm One-third
tubular plate |
| | | | 058 | 4.0mm cancellous screw
partially threaded | | |
| | | | 059 | 4.0mm cancellous screw
fully threaded | | |
| Small
fragments | 110,
111,
172,
&
173 | ALP titanium
distal tibia
plates TIDIS &
TIDIS-III | 112 | 3.5mm titanium cortex
screw | | ALP titanium distal
tibia plate
TIDIS I AND
TIDIS III |
| | | | 106 | 3.5mm titanium cortex
locking screw | TQ-011 | |
| | | | 107 | 3.5mm titanium
cancellous locking
screw | | |
| | 129 | ALP titanium
proximal
humerus plate
PROH-LOCK
LARGE | 112 | 3.5mm titanium cortex
screw | TQ-014 | ALP titanium
humerus plate
PROH-LOCK and
PROH-LOCK
LARGE |
| | | | 106 | 3.5mm titanium cortex
locking screw | | |
| | | | 107 | 3.5mm titanium
cancellous locking
screw | | |
| | 144
&
145 | ALP titanium
distal lateral
humerus plate
DH-LOCK | 112 | 3.5mm titanium cortex
screw | TQ-017 | ALP titanium distal
lateral humerus
plate and ALP
titanium
Distal medial
humerus plate DH-
LOCK |
| | | | 106 | 3.5mm titanium cortex
locking screw | | |
| | | | 107 | 3.5mm titanium
cancellous locking
screw | | |
| | | | 170 | 2.7mm titanium cortex
locking screw | | |
| | 148,
148S,
149,
&
149S. | ALP titanium
distal radius
plate LIONTER | 154X | 2.5mm titanium cortex
screw Torx drive | TQ-018 | ALP titanium distal
radius plate |
| | | | 155X | 2.5mm titanium cortex
locking screw Torx
drive | | |
6
| Fixier |
|---|
| Traufix osteosynthesis, osteotomy and arthrodesis devices |
| Plate
type | Plate
code | Plate
description | Screw
code | Screw description | Surgical
technique # | Surgical technique
name |
|--------------------|-----------------|--------------------------------------------------|---------------|----------------------------------------------------------|-------------------------|----------------------------------------------------|
| | 164
&
165 | ALP titanium
distal tibia
plates TIDIS-III | 112 | 3.5mm titanium cortex
screw | TQ-023 | ALP titanium distal
plate TIDIS II |
| | | | 106 | 3.5mm titanium cortex
locking screw | | |
| | | | 107 | 3.5mm titanium
cancellous locking
screw | | |
| | 023 | 4.5mm
Reconstruction
plates | 056 | 4.5mm cortex screw | TQ-009 | Reconstruction
plates |
| | | | 060 | 6.5mm cancellous screw
16mm thread | | |
| | | | 061 | 6.5mm cancellous screw
32mm thread | | |
| | | | 062 | 6.5mm cancellous screw
fully threaded | | |
| Large
fragments | 150
&
151 | ALP titanium
proximal femur
plate TLP | 126 | 4.5mm titanium cortex
screw | TQ-019 | ALP titanium
proximal femur
plate TLP |
| | | | 108 | 5.0mm titanium cortex
locking screw | | |
| | | | 171 | 5.0mm titanium
cannulated cortex
locking screw | | |
| | | | 109 | 5.5mm titanium
cancellous locking
screw | | |
| | | | 156 | 7.3mm titanium
cannulated cancellous
locking screw | | |
| | 152
&
153 | ALP titanium
proximal tibia
plate OPTIMUS | 126 | 4.5mm titanium cortex
screw | TQ-020 | ALP titanium
proximal
Tibia plate
OPTIMUS |
| | | | 108 | 5.0mm titanium cortex
locking screw | | |
| | | | 109 | 5.5mm titanium
cancellous locking
screw | | |
| Substantial
Equivalence: | Traufix osteosynthesis, osteotomy, and arthrodesis devices and
predicate devices have the same indications for use, target
population, patient contact, materials, and sterilization methods. |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Traufix subject devices, and predicate devices are intended for
fracture fixation and minor differences exist in the physical shape
and dimension characteristics of the plates and screws. However,
these minor dimensional differences do not raise any new
questions of safety or effectiveness. |
| Primary Predicate
Device: | AUXEIN BRAND Of Bone Plates and Bone Screws & AUXEIN
BRAND Of DCS Plate System AUXEIN brand of Locking Plates
and Locking Screws, (K141680) |
7
| Other Predicate
Devices: | -Synthes (USA) Modular Mini Fragment LCP System, (K063049)
-Synthes (USA) Medial Distal Tibia Plates, (K001945)
-Synthes Variable Angle Locking Compression Plate (VA-LCP),
(K071184)
-Synthes One-Third Tubular DCL Plate, (K011335)
-Synthes 4.5mm LCP Straight Reconstruction Plates, (K051986)
-Synthes (USA) LCP Proxima Humerus Plates, Long, (K041860) |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-Clinical
(Performance Testing): | -Non-clinical testing was performed in the subject devices as
follows:
-Single cycle bend testing was performed according to ASTM
F382.
-Breaking torque testing was performed according to ISO 6475.
-Engineering analysis was performed to compare the
structural properties per ASTM F382 A1 (bending stiffness,
bending structural stiffness, and bending strength) of the proximal
tibia plate (subject device) and proximal tibia plate (predicate
device one).
-Engineering analysis and comparison of technology was also
provided to compare design and dimensions of the subject and
predicate plates and screws. |
| Clinical Testing: | Clinical testing is not a prerequisite, as osteosynthesis, osteotomy,
and arthrodesis implants conform to recognized standards and have
well established safety and performance characteristics. Therefore,
clinical information is not necessary to demonstrate safety and
effectiveness or substantial equivalence. |
| Conclusion: | The Traufix osteosynthesis, osteotomy, and arthrodesis devices
have been found to be substantially equivalent to the predicate
devices. Differences between the subject devices and the predicate
devices do not raise new questions of safety or effectiveness. |