(28 days)
Not Found
No
The 510(k) summary describes a system of screws for bone fixation and does not mention any AI or ML components or functionalities.
Yes
The device is intended for fixation of fractures, osteotomies, and nonunions, which are medical conditions that require treatment to restore health.
No
The device is described as an "EVOLVE® EPS ORTHOLOC™ System" intended for "fixation of fractures, osteotomies and nonunions". This indicates it is a surgical implant used for treatment, not for diagnosing conditions.
No
The device description explicitly states that the device is made from implant grade stainless steel screws, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of fractures, osteotomies, and nonunions of specific bones (olecranon, humerus, radius, and ulna). This is a surgical implant used directly on the patient's body.
- Device Description: The device is described as screws made from implant-grade stainless steel. This is a physical implant.
- 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 compatibility testing.
IVD devices are used outside the body to analyze samples. This device is an orthopedic implant used inside the body for structural support.
N/A
Intended Use / Indications for Use
The system indications for both subject ORTHOLOC™ 3DSi Locking Screws and predicate EVOLVE® EPS ORTHOLOC™ (K102352) are identical.
EVOLVE® EPS ORTHOLOC™ System is intended for fixation of fractures. osteotomies and nonunions of the olecranon, humerus, radius, and ulna.
Product codes
HRS, HWC
Device Description
The ORTHOLOCM 3DSi Locking Screws are made from implant grade stainless steel and are available with cortical and cancellous thread forms in multiple length and diameters.
These screws are manufactured from stainless steel conforming to ASTM F2229.
The design features of the ORTHOLOC™ 3DSi Locking Screws are identical to the design features of the predicate devices EVOLVE® EPS ORTHOLOC™ System Locking Screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
olecranon, humerus, radius, and ulna
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
Not Found
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
Image /page/0/Picture/0 description: The image shows the text "K113339 Page 1/2 DEC 12 2011" on the left side and the word "WRIGHT" on the right side. The text on the left side appears to be handwritten, while the word on the right side is in a bold, sans-serif font. The word "WRIGHT" also has a thick, black line underneath it.
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 ORTHOLOC™ 3DSi Locking Screws.
| A.1. Submitted By: | Wright Medical Technology, Inc.
5677 Airline Rd
Arlington, TN 38002 |
|-----------------------------------|---------------------------------------------------------------------------|
| Date: | October 28, 2011 |
| Contact Person: | Peggy S. Rivers
Regulatory Affairs Specialist
(901) 867-4759 |
| A.2. Proprietary Name: | ORTHOLOC™ 3DSi Locking Screws |
| Common Name: | Locking Screws |
| Device Classification Regulation: | 21 CFR 888.3030—Class II |
| Device Product Code & Panel: | HRS: Plate, Fixation Bone
87 Orthopedics |
| A.3. Predicate Device: | K102352—EVOLVE® EPS ORTHOLOC™ System |
A.4. Device Description
The ORTHOLOCM 3DSi Locking Screws are made from implant grade stainless steel and are available with cortical and cancellous thread forms in multiple length and diameters.
These screws are manufactured from stainless steel conforming to ASTM F2229.
The design features of the ORTHOLOC™ 3DSi Locking Screws are identical to the design features of the predicate devices EVOLVE® EPS ORTHOLOC™ System Locking Screws.
1
K113339 Page 2/2 WRIGHT.
A.5. Intended Use
The system indications for both subject ORTHOLOC™ 3DSi Locking Screws and predicate EVOLVE® EPS ORTHOLOC™ (K102352) are identical.
EVOLVE® EPS ORTHOLOC™ System is intended for fixation of fractures. osteotomies and nonunions of the olecranon, humerus, radius, and ulna.
A.6. Technological Characteristics Comparison
The subject ORTHOLOC™ 3DSi Locking screws are identical to the previously cleared EVOLVE® EPS ORTHOLOC™ Locking screws (K102352) with only minor change to feature call-outs on the engineering drawing.
B.1. Substantial Equivalence - Non-Clinical Evidence
Substantial equivalence is demonstrated through materials information and a composition of design characteristics.
B.2. Substantial Equivalence - Clinical Evidence
N/A
B.3. Substantial Equivalence - Conclusions
The subject screws are identical in indication for use, diameter, size range and material to the predicate. No new types of safety and effectiveness questions can be expected. From the evidence given in the Premarket Notification, the subject devices can be expected to perform at least as well as the predicate devices.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 1 2 2011
Wright Medical Technology, Inc. % Ms. Peggy S. Rivers 5677 Airline Rd. Arlington, TN 38002
Re: K113339
Trade/Device Name: Ortholoc™ 3DSi Locking Screws Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: II Product Code: HRS. HWC Dated: November 11", 2011 Received: November 14th, 2011
Dear Ms. Rivers:
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.
3
Page 2 - Ms. Peggy S. Rivers
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Evin S. Keith
J Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: EVOLVE® EPS ORTHOLOC ™ System with ORTHOLOC™ 3DSi Locking Screws
Indications For Use:
EVOLVE® EPS ORTHOLOC™ System: Intended for fixation of fractures, osteotomies and nonunions of the olecranon, humerus, radius, and ulna
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael Chas
fn mxm
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K 113339
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