(53 days)
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No
The provided text describes a mechanical orthopedic plate and screw system with no mention of software, algorithms, or any features indicative of AI/ML.
Yes
Explanation: The device is intended for stabilization of fractures and reconstruction of bones, which are therapeutic interventions.
No
The ORTHOLOC® 2.0 / 2.4 Plate System is described as a system for stabilization of fractures and reconstruction of bones, which indicates it is a therapeutic or reconstructive device, not a diagnostic one. Its intended use focuses on treatment rather than identifying or diagnosing a condition.
No
The device description clearly states it consists of physical components like plates and screws made of Titanium and Titanium Alloy, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The ORTHOLOC® 2.0 / 2.4 Plate System is a surgical implant used to stabilize bones. It is a physical device implanted into the body, not a test performed on a sample outside the body.
- Intended Use: The intended use is for the stabilization of fractures and reconstruction of bones, which is a surgical procedure, not a diagnostic test.
Therefore, based on the provided information, the ORTHOLOC® 2.0 / 2.4 Plate System is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ORTHOLOC® 2.0 / 2.4 Plate System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system can be used in both adult and pediatric patients. Examples include: Metatarsal or metacarpal fractures and osteotomies Phalanges fractures and osteotomies
Product codes
HRS, HWC
Device Description
- Consists of a variety of flat and pre-contoured plate geometries .
- Plates feature compression slots and locking screw holes .
- Manufactured from Titanium and Titanium Alloy .
- Screws are available in both locking and non-locking designs .
- Screws are available in 2 diameters and 7 lengths in the small diameter and 12 lengths in . the large diameter
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
small bones of the hand, feet, wrist, ankles, fingers and toes. Metatarsal or metacarpal fractures and osteotomies Phalanges fractures and osteotomies
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 ー 8 2009
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 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the ORTHOLOC® 2.0 / 2.4 System.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | March 13, 2009 |
| Contact Person: | Fred W. Bowman, P.E. |
| Senior Regulatory Affairs Specialist | |
| Proprietary Name: | ORTHOLOC® 2.0/2.4 Plate & ORTHOLOC® 2.0/2.4 Screw |
| Common Name: | Bone Fixation Plate & Bone Screw |
| Classification Name and Reference: | 21 CFR 888.3030 Plate, Fixation, Bone - Class II |
| 21 CFR 888.3040 Screw, Fixation, Bone - Class II | |
| Device Product Code and Panel Code: | Orthopedics/87/HRS |
| Orthopedics/87/HWC |
DEVICE INFORMATION
A. INTENDED USE
The ORTHOLOC® 2.0 / 2.4 Plate System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system can be used in both adult and pediatric patients. Examples include:
Metatarsal or metacarpal fractures and osteotomies Phalanges fractures and osteotomies
B. DEVICE DESCRIPTION
The design features of the ORTHOLOC® 2.0 / 2.4 System are described below.
- Consists of a variety of flat and pre-contoured plate geometries .
- Plates feature compression slots and locking screw holes .
- Manufactured from Titanium and Titanium Alloy .
- Screws are available in both locking and non-locking designs .
- Screws are available in 2 diameters and 7 lengths in the small diameter and 12 lengths in . the large diameter
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Image /page/1/Picture/0 description: The image shows a sequence of handwritten characters. The sequence starts with the letter 'K', followed by the numbers '090692'. The characters are written in black ink on a white background and appear to be part of a serial number or identification code.
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The design features, material, and indications for use of the ORTHOLOC® 2.0/2.4 System are substantially equivalent to previously cleared predicate devices. The safety and effectiveness of the ORTHOLOC® 2.0/2.4 System is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
MAY - 8 2009
AY - 8 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Wright Medical Technology, Inc. % Mr. Fred W. Bowman, P.E. Senior Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002
Re: K090692
Trade/Device Name: Ortholoc 2.0/2.4 Plate & Ortholoc 2.0/2.4 Screw Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: March 13, 2009 Received: March 16, 2009
Dear Mr. Bowman:
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.
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 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.
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Page 2- - Mr. Fred W. Bowman, P.E.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Daniel Keane
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: ORTHOLOC® 2.0 / 2.4 Plate System
Indications For Use:
The ORTHOLOC® 2.0 / 2.4 Plate System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system can be used in both adult and pediatric patients. Examples include:
Metatarsal or metacarpal fractures and osteotomies Phalanges fractures and osteotomies
Prescription Use (Part 21 CFR 801 Subpart D)
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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)
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090692
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