(45 days)
Not Found
No
The description focuses on the mechanical properties and intended use of titanium plates for bone fixation, with no mention of AI or ML.
Yes
The device, the TC Plating System, is intended for "stabilization of small bone fragments in fresh fractures, revision procedures, joint fusion of small bones..." and specific examples of use include "Mid / Flatfoot Fusions" and "Arthrodesis of the first metatarsophalangeal joint (MTP)". These are all procedures to treat or manage a disease or condition (fractures, joint fusion), which aligns with the definition of a therapeutic device.
No
Explanation: The device is a plating system designed for stabilization and fixation of small bone fragments, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is comprised of titanium plates, which are hardware components, not 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 implant for stabilizing bone fragments and performing fusions. This is a therapeutic device used in vivo (within the body).
- Device Description: The description details titanium plates designed for internal fixation, which are surgical 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 screening.
IVD devices are used to perform tests outside the body on biological samples. This device is a surgical implant used inside the body.
N/A
Intended Use / Indications for Use
The TC Plating System is intended for essentially non-load bearing stabilization of small bone fragments in fresh fractures, revision procedures, joint fusion of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe and pelvis.
Specific examples of use in the foot include:
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
- First metatarsal osteotomies for hallux valgus correction including:
- · 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)
- Arthrodesis of the first metatarsophalangeal joint (MTP) including:
- Primary MTP Fusion due to hallux ridgidus and/or hallux valgus
- · Revision MTP Fusion
- · Revision of failed first MTP Arthroplasty implant
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The TOTAL COMPRESSION PLATING SYSTEM is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation of small bone fragments. Most of the plates are scalloped in shape to allow easier bending to fit the contour of the bone. There are also non-scalloped plates to provide greater strength. The plates include straight, right, and left configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand, foot, wrist, ankle, humerus, scapula, finger, toe and pelvis.
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 and engineering analysis has shown that the performance of the subject plating system is statistically equivalent or greater than the predicate plating system. Specifically cantilever bend testing was performed and used to assess ultimate load, yielding bending moment, bending stiffness, and maximum deflection according to ASTM F2193.
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.
K094037 TC Plating System, K121651 ORTHOLOC 3Di Midfoot/Flatfoot System, K120359 ORTHOLOC 3Di Hallux System
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 seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 5, 2014
Wright Medical Technology, Inc. Ms. Jeanine Redden Director, Regulatory Affairs 1023 Cherry Road Memphis. Tennessee 38117
Re: K143025
Trade/Device Name: Total Compression Plating (TCP) 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 Dated: October 20, 2014 Received: October 21, 2014
Dear Ms. Redden:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
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/Resourcesfor You/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,
Vincent J. Devlin -S
- for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K143025
Device Name
TOTAL COMPRESSION PLATING (TCP) SYSTEM
Indications for Use (Describe)
The TC Plating System is intended for essentially non-load bearing stabilization of small bone fragments in fresh fractures, revision procedures, joint fusion of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe and pelvis.
Specific examples of use in the foot include:
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
- First metatarsal osteotomies for hallux valgus correction including:
- · 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)
- Arthrodesis of the first metatarsophalangeal joint (MTP) including:
- Primary MTP Fusion due to hallux ridgidus and/or hallux valgus
- · Revision MTP Fusion
- · Revision of failed first MTP Arthroplasty implant
|×| 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)
3
K143025 - Page 1 of 3
Headquarters Wright Medical Technol
1023 Cherry Road
Memphis, TN 38117
901.857.997
wmnt.com
Image /page/3/Picture/4 description: The image shows the Wright logo. The logo consists of two overlapping trapezoids, one red and one orange, followed by the word "WRIGHT" in red, and the words "FOCUSED EXCELLENCE" in a smaller font below the word "WRIGHT". The logo is simple and modern.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the TOTAL COMPRESSION PLATING SYSTEM.
| 1. Submitted By: | Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 |
|---|---|
| Date: | November 24, 2014 |
| Contact Person: | Jeanine Redden Director, Regulatory Affairs Phone: 901.867.4255 Fax: 901.867.4190 |
| 2. Proprietary Name: | TOTAL COMPRESSION PLATING SYSTEM |
| Common Name: | Plate, Fixation, Bone |
| Classification Name and Reference: | 21 CFR 888.3030- Class II |
| Device Product Code, Device Panel: | HRS - Orthopedic |
| 3. Predicate Device: | K094037 TC Plating System K121651 ORTHOLOC 3Di Midfoot/Flatfoot System K120359 ORTHOLOC 3Di Hallux System |
| 4. Device Description |
The TOTAL COMPRESSION PLATING SYSTEM is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation of small bone fragments. Most of the plates are scalloped in shape to allow easier bending to fit the contour of the bone. There are also non-scalloped plates to provide greater strength. The plates include straight, right, and left configurations.
4
5. Intended Use
The TC Plating System is intended for essentially non-load bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe and pelvis.
Specific examples of use in the foot include:
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
First metatarsal osteotomies for hallux valgus correction including:
- · 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) Arthrodesis of the first metatarsophalangeal joint (MTP) including:
- · Primary MTP Fusion due to hallux ridgidus and/or hallux valgus
- · Revision MTP Fusion
- · Revision of failed first MTP Arthroplasty implant
Technological Characteristics Comparison 6.
The TOTAL COMPRESSION PLATING SYSTEM compared to the legally marketed predicate device has the same indications and is composed of the same material as the predicate screws and plates. The geometry of the subject screws and plates differ from the predicate screws and plates. Mechanical testing and engineering analysis ensure that the subject devices are substantially equivalent to the predicate devices.
5
7. Substantial Equivalence- Non-Clinical Evidence
Mechanical testing and engineering analysis has shown that the performance of the subject plating system is statistically equivalent or greater than the predicate plating system. Specifically cantilever bend testing was performed and used to assess ultimate load, yielding bending moment, bending stiffness, and maximum deflection according to ASTM F2193.
8. Substantial Equivalence- Clinical Evidence
N/A
9. Substantial Equivalence- Conclusions
The design characteristics of the subject devices do not raise any new types of questions of safety or effectiveness. Mechanical testing and engineering analysis has shown that the performance of the subject plating system is statistically equivalent or greater than the predicate plating system. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate systems and are substantially equivalent.