(28 days)
Not Found
No
The document describes a plating system for bone fixation and does not mention any AI or ML components or functionalities.
Yes
The device is a plating system used for stabilization, fixation, fusion, and reconstruction of small bones, which are therapeutic interventions.
No
The device is a plating system intended for the stabilization and fixation of fractures, fusions, and reconstructions of small bones in the foot. It is used as a treatment device, not for diagnosis.
No
The device description explicitly states that the device includes physical components such as plates and screws made from titanium alloy. It is a hardware-based medical device.
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 being used for the stabilization, fusion, and reconstruction of small bones, specifically in the foot. This is a surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as plates and screws made of titanium alloy, which are implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the TMC Plating System is a surgical device, not an In Vitro Diagnostic device.
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
The previously cleared Treace Medical Concepts (TMC) Plating System includes straight, L-shaped, H- shaped, and Python plates and 2.5mm-3.0mm diameter screws in lengths ranging from 10-32mm. 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.
The purpose of this special 510(k) submission is to add the Lapiplasty® Mini-Incision™ Plates to the TMC Plating System. The subject plates are based on the design of the previously cleared Lapiplasty® S1 Plate (K192504). The subject plates are used with the same screws as the predicate plate.
All implantable components are manufactured from medical grade titanium alloy (Ti-6Al-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.
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
adult and pediatric patients.
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
Dynamic 4-point bend testing has been performed per ASTM F382 on the subject plates. The results have shown subject device to be substantially equivalent to the primary predicate. Additionally, an engineering analysis of the subject device concluded that its performance with respect to static 4-point bend testing is equivalent to the predicate device. Thus, the addition of these plates does not present a new worst case with respect to static or dynamic 4-point bend testing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
May 8, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font size below.
Treace Medical Concepts, Inc. % Danielle Besal Principal Consultant MRC Global 9085 East Mineral Circle, Suite Centennial, Colorado 80112
Re: K200961
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: April 8, 2020 Received: April 10, 2020
Dear Danielle Besal:
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.
1
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 mediation-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.
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K200961
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 May 7, 2020
| Company: | Treace Medical Concepts, Inc.
203 Fort Wade Rd., Suite 150
Ponte Vedra, FL 32081 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Danielle Besal
Principal Consultant, MRC Global
Phone: 901-827-8670
Danielle.Besal@askmrcglobal.com |
| Company/Secondary Contact: | Rachel Osbeck
VP, Quality Assurance & Regulatory Affairs
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 |
| Product Code: | HRS and HWC |
| Primary Predicate: | K192504 Treace Medical Concepts (TMC) Plating System |
4
Device Description:
The previously cleared Treace Medical Concepts (TMC) Plating System includes straight, Lshaped, H- shaped, and Python plates and 2.5mm-3.0mm diameter screws in lengths ranging from 10-32mm. 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.
The purpose of this special 510(k) submission is to add the Lapiplasty® Mini-Incision™ Plates to the TMC Plating System. The subject plates are based on the design of the previously cleared Lapiplasty® S1 Plate (K192504). The subject plates are used with the same screws as the predicate plate.
All implantable components are manufactured from medical grade titanium alloy (Ti-6Al-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.
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)
5
Substantial Equivalence:
The subject TMC Plating System is substantially equivalent to the predicate Treace Medical Concepts (TMC) Plating System (K192504, S.E. 10/30/2019).
The subject plates are manufactured from titanium (Ti-6Al-4V-ELI) and are intended to be used in stabilization of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the feet, identical to the predicate devices. Indications for use have not changed and are identical to the predicate device. The subject plates also share similar geometry and construction with the predicate plate. Thus, it can be concluded that the subject does not raise different questions about safety and effectiveness.
Performance Testing:
Dynamic 4-point bend testing has been performed per ASTM F382 on the subject plates. The results have shown subject device to be substantially equivalent to the primary predicate. Additionally, an engineering analysis of the subject device concluded that its performance with respect to static 4-point bend testing is equivalent to the predicate device. Thus, the addition of these plates does not present a new worst case with respect to static or dynamic 4-point bend testing.
Conclusion:
The Treace Medical Concepts (TMC) Plating System has identical intended use, similarities in design and construction, and equivalent performance to the predicate device as demonstrated through bench testing and engineering analysis. Therefore, it can be concluded that the subject device is as safe, as effective, and performs at least as safely and effectively as the predicate device.