(55 days)
Not Found
No
The device description and intended use clearly describe a mechanical plating system for bone fixation. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes
The device is intended for fixation of fractures and osteotomies, which are medical treatments designed to restore health or proper function.
No
Explanation: The device, the OptiLock Upper Extremity Plating System, is described as an "internal fixation device" for "fixation of fractures and osteotomies." Its purpose is to stabilize bones, not to diagnose medical conditions.
No
The device description clearly states it is an "internal fixation device used to provide surgeons with bone plates" and mentions "locking screws," "non-locking screws," and "instruments." These are all physical 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 states the device is for "fixation of fractures and osteotomies" and is an "internal fixation device." This describes a surgical implant used directly on the patient's bone.
- Device Description: The description details bone plates, screws, and instruments used in surgery. This aligns with a surgical device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used for structural support and fixation within the body.
N/A
Intended Use / Indications for Use
The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies.
The System is intended for fractures and fracture dislocations, osteotomies and nonunions of the proximal humerus, particularly in osteopenic bone.
The System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius, ulna, particularly in osteopenic bone.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The EBI OptiLock Upper Extremity Plating System is an internal fixation device used to provide surgeons with bone plates that are capable of using locking screws for better stability and non-locking screws for compression. Threaded slots are also available for non-locking screws to hold the plate to the bone while adjusting the plate along the length of the bone. The shapes of the plates are pre-contoured to the shape of the bone and the holes on the plate are threaded in such a way as to permit surgeons a choice of locking or non-locking screws. Instruments allow minimum incision during surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal humerus, olecranon, humerus, radius, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
Synthes Small Fragment Dynamic Compression Locking (DCL) System 0 (K000684), Synthes LCP Proximal Humerus Plate (K011815), Synthes LCP Proximal Humerus Plate, Long (K041860), D Synthes 3.5 mm LCP Distal Humerus System (K033995), C Synthes 3.5 mm Cortex Screws (K043185)
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
K0624994
OCT 1.9 2006
510(k) Summary
This 510(k) Summary for the EBI® OptiLock Upper Extremity Plating System is provided as required per Section 513(3) of the Food, Drug and Cosmetic Act.
| 1. | Submitter: | EBI, L.P. |
|---|---|---|
| 2. | Submission Prepared by: | Amy-Ahlam Chaibi |
| Regulatory Affairs Specialist | ||
| 3. | Contact Person: | Debra Bing |
| 100 Interpace Parkway | ||
| Parsippany, NJ 07054 | ||
| Phone: (973) 299-9300, ext. 3964 |
Date prepared: August 18, 2006
| 4. Proprietary Name: | EBI® OptiLock Upper Extremity Plating System |
|---|---|
| Common Name: | Internal Fixation Device |
| Classification Names: | Smooth or Threaded Metallic Bone |
| Fixation Fastener, 21 CFR 888.3040 | |
| Single/Multiple Component Metallic Bone Fixation | |
| Appliances and Accessories, 21 CFR 888.3030 |
5. Predicate or legally marketed devices that are substantially equivalent:
- Synthes Small Fragment Dynamic Compression Locking (DCL) System 0 (K000684)
- Synthes LCP Proximal Humerus Plate (K011815) o
- Synthes LCP Proximal Humerus Plate, Long (K041860) ם
- D Synthes 3.5 mm LCP Distal Humerus System (K033995)
- C Synthes 3.5 mm Cortex Screws (K043185)
6. Description of the device:
The EBI OptiLock Upper Extremity Plating System is an internal fixation device used to
provide surgeons with bone plates that are capable of using locking screws for better
stability and non-locking screws for compression. Threaded slots are also available for
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non-locking screws to hold the plate to the bone while adjusting the plate along the length of the bone. The shapes of the plates are pre-contoured to the shape of the bone and the holes on the plate are threaded in such a way as to permit surgeons a choice of locking or non-locking screws. Instruments allow minimum incision during surgery.
7. Intended Use:
The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies.
The System is intended for fractures and fracture dislocations, osteotomies and nonunions of the proximal humerus, particularly in osteopenic bone.
The System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius, ulna, particularly in osteopenic bone.
8. Materials:
The EBI® OptiLock Upper Extremity Plating System is manufactured from Stainless Steel as per ASTM F621-02, ASTM F138-03 and ASTM F139-03, and Titanium as per ASTM F136 and F620.
9. Comparison of the technological characteristics of the device to predicate
devices: There are no significant differences between the EBI® OptiLock Upper Extremity Plating System and other currently marketed internal fixation systems. It is substantially equivalent* to the predicate devices in regard to intended use, materials. and function.
- Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to relate to whether the product can be lawfully marketed without pre-market approval or reclassification and is not interpreted as an admission or any other type of evidence in patent infringement litigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EBI, L.P. % Ms. Amy Ahlam Chaibi Regulatory Affairs Director 100 Interface Parkway Parsippany, New Jersey 07054
OCT 1 9 2006
Re: K062494
Trade/Device Name: EBI® OptiLock Upper Extremity Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Pedicle screw spinal system Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: August 21, 2006 Received: August 25, 2006
Dear Ms. Chaibi:
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 such 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); 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 – Ms. Amy Ahlam Chaibi
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Pen Cult
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
Page __ 1 __ of __ 1
510(k) Number (if known): _____________________________
Device Name: EBI® OptiLock Upper Extremity Plating System
Indications For Use:
The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies.
The System is intended for fractures and fracture dislocations, osteotomies and nonunions of the proximal humerus, particularly in osteopenic bone.
The System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius, ulna, particularly in osteopenic bone.
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
(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 General, Restorative,
and Neurological Devices
510(k) Number K062447
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