(80 days)
Not Found
No
The device description and intended use are solely focused on mechanical implants (plates and screws) for bone stabilization. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI/ML.
Yes
The device is described as a "Plating System" intended for stabilization and fixation of fractures, revision procedures, fusions, and reconstructions of small bones of the feet, which are all therapeutic interventions.
No
The device is a plating system intended for stabilization and fixation of bones, not for diagnosing conditions.
No
The device description explicitly states that the system includes physical components such as plates and screws, which are hardware.
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, or tissue) to provide information about a person's health. This is done outside of the body (in vitro).
- Device Description: The description clearly states that the TMC Plating System includes plates and screws made of titanium alloy. These are implantable components used for the stabilization and fixation of fractures, fusions, and reconstructions of bones within the body.
- Intended Use: The intended use describes surgical procedures performed directly on the bones of the foot.
The TMC Plating System is a surgical implant, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The TMC Plating System is intended for use in stabilization of fresh fractures, joint fusion and reconstruction of small bones of the feet. In the foot, the system can be used for the following specific examples:
- First metatarsal osteotomies for hallux valgus correction such as:
Opening base wedge osteotomy
Closing base wedge osteotomy
Crescentic osteotomy
Proximal Chevron osteotomy
Distal Chevron osteotomy (Austin) - First metatarsal fracture fixation
- Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)
- Flatfoot Osteotomies
- Lateral Column Lengthening (Evans Osteotomy)
- Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)
- Mid / Flatfoot Fusions
LisFranc Arthrodesis and/or Stabilization
1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
Intercuneiform Fusions
Navicular-Cuneiform (NC) Fusion
Talo-Navicular (TN) Fusion
Calcaneo-Cuboid (CC) Fusion - Medial Column Fusion
- Arthrodesis of the first metatarsophalangeal joint (MTP)
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Treace Medical Concepts (TMC) Plating System includes straight, L-shaped, and H- shaped plates and 2.5mm diameter screws in lengths ranging from 10-28mm. The plates and screws are intended for use in stabilization and fixation of fractures, revision procedures, fusions, and reconstructions (osteotomy) of small bones of the foot. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bones of the feet
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)
Mechanical testing, including static and dynamic 4 point bend testing and static torsional and pullout testing have been performed per ASTM F382 and ASTM F543 on the subject TMC Plating System and the results have shown them to be 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.
K081546, K121651, K120359, K090692
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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human profile, composed of three overlapping shapes.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 19, 2015
Treace Medical Concepts, Incorporated % Ms. Kimberly Strohkirch Memphis Regulatory Consulting, LLC 3416 Roxee Run Cove Bartlett, Tennessee 38133
Re: K143717
Trade/Device Name: Treace Medical Concepts (TMC) 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: March 2, 2015 Received: March 3, 2015
Dear Ms. Strohkirch:
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
1
Page 2 - Ms. Kimberly Strohkirch
(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 (OS) 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/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 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 yours,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
K143717
Device Name
Treace Medical Concepts (TMC) Plating System
Indications for Use (Describe)
The TMC Plating System is intended for use in stabilization of fresh fractures, joint fusion and reconstruction of small bones of the feet. In the foot, the system can be used for the following specific examples:
· First metatarsal osteotomies for hallux valgus correction such as:
- Opening base wedge osteotomy
- · Closing base wedge osteotomy
- · Crescentic osteotomy
- · Proximal Chevron osteotomy
- · Distal Chevron osteotomy (Austin)
- First metatarsal fracture fixation
- · Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)
- · Flatfoot Osteotomies
- · Lateral Column Lengthening (Evans Osteotomy)
- · Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)
- Mid / Flatfoot Fusions
- · LisFranc Arthrodesis and/or Stabilization
- · 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
- · Intercuneiform Fusions
- · Navicular-Cuneiform (NC) Fusion
- Talo-Navicular (TN) Fusion
- Calcaneo-Cuboid (CC) Fusion
- · Medial Column Fusion
- · Arthrodesis of the first metatarsophalangeal joint (MTP)
| 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) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
ATTACHMENT 2-1
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510(k) Summary
Treace Medical Concepts (TMC) Plating System February 27, 2015
| Company: | Treace Medical Concepts, Inc.
3107 Sawgrass Village Circle
Ponte Vedra Beach, FL 32082 | |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Primary Contact: | Kimberly Strohkirch
Phone: (901) 361-2037
Fax: 904.834.7169
Strohkirch@memphisregulatory.com | |
| Company/Secondary Contact: | Joe Ferguson, Chief Operating Officer
Phone: 904.373.5840 Ext. 303
Fax: 904.834.7169
jferguson@treace.net | |
| Trade Name: | Treace Medical Concepts (TMC) Plating System | |
| Common Name: | Plate, Fixation, Bone
Screw, Fixation, Bone | |
| Classification: | Class II | |
| Regulation Number: | 21 CFR 888.3030 (Single/Multiple Component Metallic Bone
Fixation Appliances and Accessories)
21 CFR 888.3040 (Smooth or Threaded Metallic Bone Fixation
Fastener) | |
| Panel: | 87- Orthopedic | |
| Product Code: | HRS | HWC |
Device Description:
The Treace Medical Concepts (TMC) Plating System includes straight, L-shaped, and H- shaped plates and 2.5mm diameter screws in lengths ranging from 10-28mm. The plates and screws are intended for use in stabilization and fixation of fractures, revision procedures, fusions, and reconstructions (osteotomy) of small bones of the foot. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI).
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Indications for Use:
The TMC Plating System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet. In the foot, the system can be used for the following specific examples:
- First metatarsal osteotomies for hallux valgus correction such as: ●
- · Opening base wedge osteotomy
- Closing base wedge osteotomy
- · Crescentic osteotomy
- Proximal Chevron osteotomy
- · Distal Chevron osteotomy (Austin)
- First metatarsal fracture fixation
- Arthrodesis of the first metatarsalcuneiform ioint (Lapidus Fusion)
- Flatfoot Osteotomies
- · Lateral Column Lengthening (Evans Osteotomy)
- Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)
- Mid / Flatfoot Fusions ●
- · LisFranc Arthrodesis and/or Stabilization
- · 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
- · Intercuneiform Fusions
- Navicular-Cuneiform (NC) Fusion
- Talo-Navicular (TN) Fusion
- Calcaneo-Cuboid (CC) Fusion
- Medial Column Fusion
- Arthrodesis of the first metatarsophalangeal joint (MTP)
Substantial Equivalence:
The subject TMC Plating System components were demonstrated to be substantially equivalent with respect to indications for use, design, dimension, and materials to the following devices, previously cleared by the FDA:
- DePuy (Biomet): ALPS Small Fragment Plating System- K081546
- Wright Medical Technology. Inc.: Ortholoc™ 3Di Foot Reconstruction Midfoot/Flatfoot . System- K121651
- Wright Medical Technology, Inc.: Ortholoc™ 3Di Hallux System- K120359
- Wright Medical Technology, Inc.: Ortholoc™ ORTHOLOC® 2.0/2.4 Plate & ● ORTHOLOC® 2 .0/2 .4 Screw- K090692
As indicated above, there are insignificant differences between the subject and predicate devices. The subject device includes all of the same indications as the predicates. The 2.5mm locking screws fall within the size range of those previously cleared by the predicates. Additionally, the subject 4-hole and 5-hole straight plates fall within the lengths of the previously cleared devices. differing only slightly in width and thickness. The subject H-plate is similar in design to the
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WMT Ortholoc™ U plate in design, with added "arms" for additional stabilization and fixation. The subject L-plate is similar to the previously cleared L-plates, differing in degree at which the "L-arm" protrudes. The subject L-plate forms a 90 degree angle, while the predicate device angles are slightly larger.
Performance Testing:
Mechanical testing, including static and dynamic 4 point bend testing and static torsional and pullout testing have been performed per ASTM F382 and ASTM F543 on the subject TMC Plating System and the results have shown them to be substantially equivalent to the predicate devices.