(56 days)
No
The 510(k) summary describes a traditional plating system for bone stabilization and fusion. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The submission focuses on expanded indications for existing hardware.
Yes.
The device is described as a 'Plating System' intended for surgical procedures such as stabilization of fractures, joint fusion, and reconstruction of small bones, which are therapeutic interventions.
No
This device, the TMC Plating System, is an orthopedic implant (plates and screws) used for stabilization of bones in the feet after fractures, fusions, or reconstructions. Its function is to provide physical support and fixation, not to diagnose medical conditions or diseases.
No
The device description explicitly states that the device is a "Plating System implants" consisting of "bone plates and screws" made from "medical grade titanium alloy". This indicates a physical hardware device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a plating system for the stabilization of fresh fractures, joint fusion, and reconstruction of small bones, specifically in the foot. This is a surgical implant used directly on the patient's body.
- Device Description: The device is described as bone plates and screws made from medical grade titanium alloy. These are physical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
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 system can be used in both adult and pediatric patients. 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-Cubiod (CC) Fusion
- Medial Column Fusion
- Arthrodesis of the first metatarsophalangeal joint (MTP)
Product codes
HRS, HWC
Device Description
This traditional 510(k) is to obtain clearance for expanded indications for the Treace Medical Concepts (TMC) Plating System implants.
The subject TMC Plating System implants include a variety of previously cleared bone plates and screws. The plates and screws are intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet.
All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones of the feet, First metatarsal, first metatarsalcuneiform joint, Mid / Flatfoot, 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT), Intercuneiform, Navicular-Cuneiform (NC), Talo-Navicular (TN), Calcaneo-Cubiod (CC), Medial Column, first metatarsophalangeal joint (MTP)
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 testing was not required to support the expanded indications for the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
January 25, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Treace Medical Concepts, Inc. % Dawn Norman Executive Vice President Memphis Regulatory Consulting, LLC 6075 Poplar Avenue, Suite 500 Memphis. Tennessee 38119
Re: K183321
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: November 28, 2018 Received: November 30, 2018
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 mav, 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.
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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
for 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) K183321
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 system can be used in both adult and pediatric patients. 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-Cubiod (CC) Fusion
-
Medial Column Fusion
-
Arthrodesis of the first metatarsophalangeal joint (MTP)
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)
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3
510(k) Summary
Treace Medical Concepts (TMC) Plating System January 25, 2019
| Company: | Treace Medical Concepts, Inc.
203 Fort Wade Rd., Suite 150
Ponte Vedra, FL 32081 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Dawn Norman
Executive Vice President, MRC X, LLC
Phone: 618.604.3064
dawn.norman@mrc-x.com |
| Company/Secondary
Contact: | Rachel Osbeck
Sr. Director, Quality Assurance
Treace Medical Concepts, LLC
Phone: 904.373.5940 Ext. 1304
rosbeck@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 |
Device Description:
This traditional 510(k) is to obtain clearance for expanded indications for the Treace Medical Concepts (TMC) Plating System implants.
4
The subject TMC Plating System implants include a variety of previously cleared bone plates and screws. The plates and screws are intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet.
All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F136.
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. The system can be used in both adult and pediatric patients. 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-Cubiod (CC) Fusion
-
Medial Column Fusion
-
Arthrodesis of the first metatarsophalangeal joint (MTP)
Substantial Equivalence:
All components of the subject system have been previously cleared under one of the following 510(k)s:
- K143717- Treace Medical Concepts(TMC) Plating System
- K153531- Treace Medical Concepts(TMC) Plating System
5
The purpose of this submission is solely to expand the indications of the TMC Plating System to include the use of the devices in pediatric patient populations, similar to the following two predicate plating systems:
- DePuy Orthopedics, Inc.: ALPS Small Fragment Plating System (K101240)
- o Wright Medical Technology, Inc.: ORTHOLOC® 2.0/2.4 Plate & ORTHOLOC® 2 .0/2 .4 Screw (K090692)
The subject components were demonstrated to be substantially equivalent with respect to indications for use, design, dimension, and materials to the previously listed predicate devices.
Performance Testing:
Performance testing was not required to support the expanded indications for the subject device.