(162 days)
No
The document describes a mechanical implant system and does not mention any software, algorithms, or data processing that would suggest the use of AI or ML.
No
The device is described as an implant system for bone reconstruction and osteotomies, which are surgical procedures, not therapeutic treatments in the sense of addressing or curing a disease or disorder through non-invasive means or active therapy. The 'Intended Use' and 'Device Description' sections clearly state its purpose for surgical fixation and reconstruction, not therapy.
No
The device, the PROSTEP TBC Implant System, is indicated for bone reconstruction and osteotomy fixation, which are therapeutic and reconstructive procedures, not diagnostic ones.
No
The device description explicitly states that the system consists of physical implants (PROSTEP TBC implant, MICA screw, and ORTHOLOC 3Di screw), which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The PROSTEP TBC Implant System is a surgical implant used for bone reconstruction and fixation. It is physically implanted into the patient's body.
- Intended Use: The intended use is for surgical procedures on the foot, specifically bone reconstruction and osteotomies. This is a direct treatment/repair of the body, not an analysis of a specimen.
The provided information clearly describes a surgical implant system, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The PROSTEP TBC Implant System is indicated for bone reconstruction. Examples include:
- Bi-Cortical osteotomies in the foot
- Distal metatarsal osteotomies
- Fixation of osteotomies for Hallux Valgus treatment (such as Transverse, Chevron, etc.)
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The PROSTEP TBC Implant System is intended for use in bone reconstruction and osteotomy of the first metatarsal. The implants are provided sterile and consist of one PROSTEP TBC implant, one MICA screw, and one ORTHOLOC 3Di screw. Based on patient anatomy and surgeon's needs, different component sizes can be selected.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Foot, first metatarsal
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)
The subject was evaluated through static and fatigue construct testing and bacterial endotoxin assessments to support the safety and effectiveness of the subject device system.
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.
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
June 6, 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.
Wright Medical Technology, Inc. Michael Mullins Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117
Re: K183620
Trade/Device Name: PROSTEP TBC Implant 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 18, 2019 Received: April 25, 2019
Dear Michael Mullins:
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.
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
1
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 medical devices and radiation-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, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183620
Device Name
PROSTEP TBC Implant System
Indications for Use (Describe)
The PROSTEP TBC Implant System is indicated for bone reconstruction. Examples include:
- · Bi-Cortical osteotomies in the foot
- Distal metatarsal osteotomies
- · Fixation of osteotomies for Hallux Valgus treatment (such as Transverse, Chevron, etc.)
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K183620 page 1/2
Headquarters Wright Medical Technology, Inc.
1023 Cherry Road Memphis, TN 38117
901 867 9971 wmt.com
510(k) SUMMARY
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 PROSTEP TBC Implant System.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| 1023 Cherry Road | |
| Memphis, TN 38117 | |
| Date: | December 21, 2018 |
| Contact Person: | Michael Mullins |
| Regulatory Affairs Specialist II | |
| Office: (901)867-4142 | |
| Fax: (901)867-4190 |
(a)(2) SUBJECT DEVICE INFORMATION
(a)(1) MANUFACTURER IDENTIFICATION
| Proprietary Name: | PROSTEP TBC Implant System |
|---|---|
| Common Name: | Single/multiple component metallic bone fixation |
| appliances and accessories / Smooth or threaded | |
| metallic bone fixation fastener | |
| Classification Name & Reference: | 21 CFR 888.3040 / 888.3030 - Class II |
| Device Product Code & Panel: | HRS / HWC - Orthopedic |
(a)(3) PREDICATE DEVICE INFORMATION
| MICA Screw System (primary) | K162353 |
|---|---|
| ORTHOLOC 3Di Ankle Fracture (reference) | K163044 |
| Mini Maxlock Extreme Plating System (reference) | K120157 |
| ORTHOLOC HALLUX (reference) | K123059 |
4
(a)(4) DEVICE DESCRIPTON
The PROSTEP TBC Implant System is intended for use in bone reconstruction and osteotomy of the first metatarsal. The implants are provided sterile and consist of one PROSTEP TBC implant, one MICA screw, and one ORTHOLOC 3Di screw. Based on patient anatomy and surgeon's needs, different component sizes can be selected.
(a)(5) INTENDED USE
The PROSTEP TBC Implant System is indicated for bone reconstruction. Examples include:
- . Bi-Cortical osteotomies in the foot
- Distal metatarsal osteotomies
- Fixation of osteotomies for Hallux Valgus treatment (such as Transverse, Chevron, etc.) ●
(a)(6) TECHNOLOGICAL CHARACTERISTICS COMPARISON
The subject device is a construct that uses cleared components and a new component to address first metatarsal hallux valgus. The subject devices intended use/indications for use is contained within the predicate. The principles of operation are similar to the predicate. Table 1 below shows a comparison of technological characteristics.
| SUBJECT | PREDICATE (primary) | |
|---|---|---|
| PROSTEP TBC Implant System | MICA Screws – K162353 | |
| Material | ASTM F136 | ASTM F136 |
| Implant | PROSTEP TBC: Small, Medium, | |
| Large | ||
| MICA Screw: Diameter: 3.0 mm | ||
| Length: 34-40 mm | Diameter: 3.0mm | |
| Length: 20-50mm | ||
| ORTHOLOC 3Di Screw | ||
| (K163044-reference predicate): | ||
| Diameter: 2.7 mm | ||
| Length: 12-14 mm |
Table 1 Subject vs Predicate Technological Comparison
(b)(1) SUBSTANTIAL EQUIVALENCE - NON-CLINICAL EVIDENCE
The subject was evaluated through static and fatigue construct testing and bacterial endotoxin assessments to support the safety and effectiveness of the subject device system.
(b)(2) SUBSTANTIAL EQUIVALENCE - CLINICAL EVIDENCE
N/A
(b)(3) SUBSTANTIAL EQUIVALENCE - CONCLUSIONS
The design characteristics of the subject device do not raise any new types of questions of safety or effectiveness and testing shows no new worst case. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate and are substantially equivalent.