(55 days)
No
The document describes a mechanical screw system for bone fixation and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
The device is described as a "Compression Screw System" intended for fixation of various bone conditions, including fractures, joint fusions, and osteotomies, which are medical treatments.
No
The device is a system of compression screws intended for the fixation of fractures, repair, and reconstruction of bones, not for diagnosis.
No
The device description explicitly states it includes "headed and headless cannulated screws" manufactured from "medical grade titanium alloy," which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this device is a system of screws intended for the fixation of bones in various anatomical locations. It is a surgical implant used directly on the patient's body.
- Lack of Mention of Biological Samples or Testing: The text does not mention any analysis of biological samples, diagnostic testing, or any function related to providing diagnostic information.
Therefore, the Treace Medical Concepts (TMC) Compression Screw System is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Treace Medical Concepts (TMC) Compression Screw System is intended for use for adult and pediatric patients, as indicated for small or long bones requiring fixation of fractures, fracture repair, revision procedures, joint fusions (arthrodesis), bone reconstructions, osteotomy, ligament fixation, and pseudoarthrosis (non-unions) of bones, including scaphoid and other carpal bones, metatarsals, phalanges, patella, ulnar styloid, capitellum, radial head and radial styloid.
In the foot, the following specific examples are indicated with screws appropriate for the size of the device:
- mono or bicortical osteotomies
- distal or proximal metatarsal osteotomies
- weil osteotomy
- fusion of the metatarsalphalangeal joint
- fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
- Akin type osteotomy
- talonavicular fusions
- cuboid fusions
Not for spinal use.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Treace Medical Concepts (TMC) Compression Screw System includes headed and headless cannulated screws, lengths 10mm (2mm increments up to 50mm, then 5mm increments). The diameters are 2.0mm to 7.5mm increments) and 3.3mm. The TMC Compression Screw System is intended for use for adult and pediatric patients, as indicated for small or long bones requiring fixation of fractures, fracture repair, revision procedures, joint fusions (arthrodesis), bone reconstructions, osteotomy, ligament fixation, and pseudoarthrosis (non-unions) of bones, including scaphoid and other carpal bones, metacarpals, tarsals, phalanges, patella, ulnar styloid, capitellum, radial head and radial styloid, appropriate for the size of the device. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI; hereafter called Ti-6-4) and anodized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small or long bones, scaphoid, other carpal bones, metatarsals, phalanges, patella, ulnar styloid, capitellum, radial head, radial styloid, foot
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
Prescription Use
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)
Performance bench testing per ASTM F543-13 was conducted on the worst-case construct of the subject Sterilization validation has been completed per ISO 11137-2:2006 and endotoxin testing devices. completed per AAMI ST72:2002/R2010. Therefore, the subject devices are substantially equivalent to the predicate devices.
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.
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.
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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized depiction of a human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
Treace Medical Concepts, Inc. % Dawn Norman Executive Vice President MRC/X 6075 Poplar Avenue, Suite 500 Memphis, Tennessee 38119
October 25, 2017
Re: K172617
Trade/Device Name: Treace Medical Concepts (TMC) Compression Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: August 30, 2017 Received: August 31, 2017
Dear Dawn Norman:
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 of medical 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
1
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 (DICE) 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" (21 CFR 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/ReportaProblem/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 (DICE) 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.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172617
Device Name
Treace Medical Concepts (TMC) Compression Screw System
Indications for Use (Describe)
The Treace Medical Concepts (TMC) Compression Screw System is intended for use for adult and pediatric patients, as indicated for small or long bones requiring fixation of fractures, fracture repair, revision procedures, joint fusions (arthrodesis), bone reconstructions, osteotomy, ligament fixation, and pseudoarthrosis (non-unions) of bones, including scaphoid and other carpal bones, metatarsals, phalanges, patella, ulnar styloid, capitellum, radial head and radial styloid.
In the foot, the following specific examples are indicated with screws appropriate for the size of the device:
- □ mono or bicortical osteotomies
- □ distal or proximal metatarsal osteotomies
- □ weil osteotomy
- □ fusion of the metatarsalphalangeal joint
- [ fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
- □ Akin type osteotomy
- □ talonavicular fusions
- □ cuboid fusions
Not for spinal use.
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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3
| K172617 510(k) Summary
Treace Medical Concepts (TMC) Compression Screw System
| September 29, 2017 | |
|---|---|
| Company: | Treace Medical Concepts, Inc. |
| 203 Fort Wade Road, Suite 150, | |
| Ponte Vedra, FL 32081 | |
| Establishment | |
| Registration: | 3011623994 |
| Primary Contact: | Dawn Norman |
| Phone: 618.604.3064 | |
| Fax: 904.834.7169 | |
| Email: dawn.norman@mrc-x.com | |
| Company/ | |
| Secondary Contact: | Rachel Osbeck, Sr. Director, Quality Assurance |
| Phone: 904.373.5940 Ext. 304 | |
| Fax: 904.834.7169 | |
| Email: rosbeck@treace.net | |
| Trade Name: | Treace Medical Concepts (TMC) Compression Screw System |
| Common Name: | Screw, Fixation, Bone |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3040 (Smooth or Threaded Metallic Bone Fixation Fastener) |
| Panel: | 87 - Orthopedic |
| Product Code: | HWC |
Predicate Devices:
Primary Predicate:
- I.T.S. Extremity Fixation Systems (K131722) .
Additional Predicates:
- Apogee OrthoSolutions, LLC Monster Screw System™ (K124027) ●
- o Smith & Nephew Cannulated Screws and Washers (K111994)
Reference Device:
- Treace Medical Plate System (K143717) ●
4
Device Description:
The Treace Medical Concepts (TMC) Compression Screw System includes headed and headless cannulated screws, lengths 10mm (2mm increments up to 50mm, then 5mm increments). The diameters are 2.0mm to 7.5mm increments) and 3.3mm. The TMC Compression Screw System is intended for use for adult and pediatric patients, as indicated for small or long bones requiring fixation of fractures, fracture repair, revision procedures, joint fusions (arthrodesis), bone reconstructions, osteotomy, ligament fixation, and pseudoarthrosis (non-unions) of bones, including scaphoid and other carpal bones, metacarpals, tarsals, phalanges, patella, ulnar styloid, capitellum, radial head and radial styloid, appropriate for the size of the device. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI; hereafter called Ti-6-4) and anodized.
Indications for Use:
The TMC Compression Screw System is intended for use for adult and pediatric patients, as indicated for small or long bones requiring fixation of fractures, fracture repair, revision procedures, joint fusions (arthrodesis), bone reconstructions, osteotomy, ligament fixation, and pseudoarthrosis (non-unions) of bones, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
In the foot, the following specific examples are indicated with screws appropriate for the size of the device:
- mono or bicortical osteotomies
- distal or proximal metatarsal osteotomies
- weil osteotomy
- o fusion of the metatarsalphalangeal joint
- fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.) ●
- Akin type osteotomy
- talonavicular fusions ●
- . cuboid fusions
Not for spinal use.
Substantial Equivalence:
The intended use and indications for use of the subject devices are substantially equivalent to the predicate devices. The materials of construction of the subject devices are equivalent to the predicate devices and the exact same materials and processing as that of the reference device. The dimensions of the subject devices are equivalent to the dimensions of the predicate devices. Thus, the subject devices are substantially equivalent to the predicate devices.
Performance Testing:
Performance bench testing per ASTM F543-13 was conducted on the worst-case construct of the subject Sterilization validation has been completed per ISO 11137-2:2006 and endotoxin testing devices. completed per AAMI ST72:2002/R2010. Therefore, the subject devices are substantially equivalent to the predicate devices.