(118 days)
Not Found
No
The summary describes a mechanical implant system (plates and screws) for bone fixation. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are non-clinical (laboratory/performance) and do not involve data analysis typical of AI/ML devices.
No
The device is described as an internal fixation plate system for stabilizing fractures and osteotomies of long bones, which is a structural support and not a therapeutic function.
No
The device is a system for internal fixation of fractures, meaning it is used for treatment (holding bones together), not for diagnosing a condition.
No
The device description clearly states it is an "extramedullary internal fixation plate system" and includes "locking screws," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary internal fixation and stabilization of fractures and osteotomies of long bones." This describes a surgical implant used within the body to stabilize bone.
- Device Description: The description details an "extramedullary internal fixation plate system" and "locking screws" for use in proximal humeral fractures. This further confirms it's a surgical implant.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests.
The information provided clearly indicates this is a surgical implant for orthopedic use, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NCB Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones.
The Tivanium 3.5mm Locking Screws are intended to be used with the NCB Polyaxial Locking Plate System.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The NCB Polyaxial Locking Plate System is an extramedullary internal fixation plate system to be used for proximal humeral fractures. It is intended to be implanted either percutaneously or by a traditional open method.
The Tivanium 3.5mm locking screws are used to engage the proximal locking screw holes within the NCB Polyaxial Locking Plate System, Proximal Humeral Plates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal humeral fractures, long bones
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)
Non-Clinical Performance and Conclusions: The results of non-clinical (Laboratory / performance) testing demonstrate that the device is safe and effective.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
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.
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
K081759 #'
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OCT 1 6 2008
12
| Summary of Safety and Effectiveness | |
|---|---|
| Sponsor: | Zimmer, GmbH |
| Sulzer Allee 8 | |
| Winterthur, Switzerland CH-8404 | |
| Contact Person: | Eric S. Pittman |
| Associate, Regulatory Affairs | |
| Telephone: (574) 371-8369 | |
| Fax: (574) 372-4605 | |
| Date: | 06/20/2008 |
| Trade Name: | NCB® Polyaxial Locking Plate System; Proximal |
| Humeral Plates and Zimmer® Universal Locking | |
| System; 3.5mm Tivanium® Ti-6Al-4V Alloy | |
| Locking Screws | |
| Common Name: | Plating System |
| Classification Name | |
| and Reference: | Plate, Fixation, Bone (21 CFR § 888.3030) |
| Screw, Fixation, Bone (21 CFR § 888.3040) | |
| Predicate Device: | NCB Plating System, manufactured by Zimmer |
| GmbH, K042695, cleared October 29, 2004 | |
| Zimmer® Universal Locking System, manufactured | |
| by Zimmer Inc., K060710, cleared April 26, 2006 | |
| Device Description: | The NCB Polyaxial Locking Plate System is an |
| extramedullary internal fixation plate system to be | |
| used for proximal humeral fractures. It is intended | |
| to be implanted either percutaneously or by a | |
| traditional open method. | |
| The Tivanium 3.5mm locking screws are used to | |
| engage the proximal locking screw holes within the | |
| NCB Polyaxial Locking Plate System, Proximal | |
| Humeral Plates. |
.
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K081759 #2/2
Intended Use:
Comparison to Predicate Device:
Performance Data (Non-clinical and/or Clinical):
The NCB Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones.
The Tivanium 3.5mm Locking Screws are intended to be used with the NCB Polyaxial Locking Plate System.
The NCB plates have the same intended use, similar performance characteristics and are similar in design and materials to the predicate device.
The Universal Locking System screws have the same intended use, similar performance and design characteristics. The proposed device is made from Tivanium (Ti-6Al-4V) alloy versus the Stainless Steel of the predicate device.
Non-Clinical Performance and Conclusions:
The results of non-clinical (Laboratory / performance) testing demonstrate that the device is safe and effective.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 6 2008
Zimmer, GmbH % Zimmer, Inc. Mr. Anthony Francalancia, RAC P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K081759 Trade/Device Name: NCB® Polyaxial Locking Plate System, Proximal Humeral Plates and Zimmer® Universal Locking System; 3.5mm Tivanium® Ti-6A1-4V Alloy Locking Screws 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: September 19, 2008 Received: September 22, 2008
Dear Mr. Francalancia:
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. Iisting 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
3
Page 2 - Mr. Anthony Francalancia, RAC
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.
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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mulkeen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): KO81759
Device Name:
NCB® Polyaxial Locking Plate System, Proximal Humeral Plates Zimmer® Universal Locking System, 3.5mm Tivanium Ti-6AL-4V Alloy Screws
Indications for Use:
The NCB Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones.
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)
Neil R. Concurrence of CDRH, Office of Device Evaluation (ODE)
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| (Division Sign-Off) | |
|---|---|
| Division of General, Restorative, | |
| and Neurological Devices | |
| 510(k) Number | K081759 |
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