(83 days)
Not Found
No
The summary describes a plating system and trial instruments for foot surgery, with no mention of AI or ML capabilities.
No
The device is a plating system used for the stabilization of small bones in the feet, which is a surgical tool rather than a therapeutic device that directly treats a condition. It is used to aid in the healing process of fractures and fusions, but it does not provide inherent therapy.
No
Explanation: The device described is a plating system used for the mechanical stabilization of fractures and fusions in the small bones of the feet. It is an orthopedic implant and instrument system, not a device used for diagnosis.
No
The device description explicitly states that the submission adds "re-usable device specific trial instruments" which are manufactured from "Titanium alloy". This indicates the device includes physical hardware components, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for stabilizing fractures, fusing joints, and reconstructing small bones in the feet. This is a therapeutic and structural purpose, not a diagnostic one.
- Device Description: The device is described as a plating system and trial instruments made of titanium alloy. This aligns with surgical implants and tools, not diagnostic reagents or equipment used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information about a patient's health status.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) for surgical intervention.
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
Device Description
The previously cleared Treace Medical Concepts, Inc (TMC) Plating System includes the PYTHON® plate. The PYTHON® Plate is a curved plate available in both left and right configurations. The plate is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet.
This submission adds re-usable device specific trial instruments as Class II Instruments (the subject device) to this system. The trial instruments are manufactured from Titanium alloy conforming to ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Engineering analysis has confirmed the subject instruments to be substantially equivalent to the predicate PYTHON® Plates.
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.
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".
Treace Medical Concepts, Inc. % Dawn Norman Executive Vice President MRC|X, LLC. 203 Fort Wade Rd., Suite 150 Ponte Vedra, Florida 32081
March 19, 2018
Re: K173930
Trade/Device Name: PYTHON Plate Trial Instruments Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS Dated: February 19, 2018 Received: February 20, 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 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);
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Page 2 - Dawn Norman
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Katherine D. Kavlock -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) K173930
Device Name
PYTHON Plate Trial Instruments
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) X 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.
3
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510(k) Summary
PYTHON® Plate Trial Instruments December 22, 2017
| 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: | PYTHON Plate Trial Instruments |
| Common Name: | Plate, Fixation, Bone |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3030 (Single/Multiple Component Metallic Bone
Fixation Appliances and Accessories) |
| Panel: | 87- Orthopedic |
| Product Code: | HRS |
Device Description:
The previously cleared Treace Medical Concepts, Inc (TMC) Plating System includes the PYTHON® plate. The PYTHON® Plate is a curved plate available in both left and right configurations. The plate is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet.
This submission adds re-usable device specific trial instruments as Class II Instruments (the subject device) to this system. The trial instruments are manufactured from Titanium alloy conforming to ASTM F136.
5
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 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)
Substantial Equivalence:
The subject PYTHON® Plate Trial Instrument components were demonstrated to be substantially equivalent with respect to indications for use, design, dimension, and materials to the following device, previously cleared by the FDA:
- Treace Medical Concepts, Inc (TMC) Plating System- PYTHON® Plate (K153531) ●
The intended use and indications for use, material and overall geometry for the predicate device is identical to those of the subject device. As the subject device is a trial instrument, and is not intended for implantation, it has additional attached drill guides that can be used to replace the modular drill guides which were cleared with the predicate implant. These drill guides allow bone preparation to be performed through the trial instrument and do not raise new questions about safety and effectiveness.
Performance Testing:
Engineering analysis has confirmed the subject instruments to be substantially equivalent to the predicate PYTHON® Plates.